[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15765-15779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 028
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 028'' (Recognition List Number: 028), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments concerning this
document at any time. See section VII of this document for the
effective date of the recognition of standards announced in this
document.
ADDRESSES: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 028'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993. Send two self-addressed adhesive labels to assist that office in
processing your requests, or fax your request to 301-847-8149. Submit
electronic comments concerning this document to [email protected].
Submit written comments concerning this document, or recommendations
for additional standards for recognition, to the contact person (see
FOR FURTHER INFORMATION CONTACT). This document may also be accessed on
FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 028 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire
[[Page 15766]]
Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993, 301-796-6574.
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1 of this
document.
Table 1--Previous Publication of Standard Recognition Lists
------------------------------------------------------------------------
-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561)
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718)
May 21, 2007 (72 FR 28500)
September 12, 2007 (72 FR 52142)
December 19, 2007 (72 FR 71924)
September 9, 2008 (73 FR 52358)
March, 18, 2009 (74 FR 11586)
September 8, 2009 (74 FR 46203)
May 5, 2010 (75 FR 24711)
June 10, 2010 (75 FR 32943)
October 4, 2010 (75 FR 61148)
March 14, 2011 (76 FR 13631)
August 2, 2011 (76 FR 46300)
------------------------------------------------------------------------
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the Agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 028
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 028'' to identify these current
modifications.
In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III of this document, FDA lists modifications the Agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 2--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-15.................................. .............. ISO 5361-4 Second edition 1987- Contact person.
12-15 Tracheal tubes--Part 4:
Cole type.
1-18.................................. .............. ISO 8359 Second edition 1996- Contact person.
12-15 Oxygen concentrators
for medical use--Safety
requirements.
1-35.................................. .............. ISO 5361 First edition 1999-09- Contact person.
15 Corrected and reprinted
1999-12-15 Anaesthetic and
respiratory equipment--
Tracheal tubes and connectors.
1-36.................................. .............. ISO 5366-3 Second edition 2001- Contact person.
08-15 Anaesthetic and
respiratory equipment--
Tracheostomy tubes--Part 3:
Pediatric tracheostomy tubes.
1-44.................................. .............. ISO 5366-1 Fourth edition 2000- Contact person.
12-15 Anaesthetic and
respiratory equipment--
Tracheostomy tubes--Part 1:
Tubes and connectors for use
in adults.
1-46.................................. .............. ISO 5367 Fourth edition 2000- Contact person.
06-01 Breathing tubes
intended for use with
anaesthetic apparatus and
ventilators.
1-56.................................. .............. CGA V-7.1:1997 (Reaffirmed Contact person.
2008) Standard Method of
Determining Cylinder Valve
Outlet Connections for
Medical Gases.
1-57.................................. .............. ASTM F1101-90 (Reapproved Contact person.
2003) \1\ Standard
Specification for Ventilators
Intended for Use During
Anesthesia.
1-58.................................. .............. ASTM G175-03 (Reapproved 2011) Reaffirmation.
Standard Test Method for
Evaluating the Ignition
Sensitivity and Fault
Tolerance of Oxygen
Regulators Used for Medical
and Emergency Applications.
1-60.................................. .............. IEC 60601-2-12 [ISO 10651-1] Contact person.
Second edition 2001-10
Medical electrical equipment--
Part 2-12: Particular
requirements for the safety
of lung ventilators--Critical
care ventilators.
1-62.................................. .............. ISO 5356-1 Third edition 2004- Contact person.
05-15 Anaesthetic and
respiratory equipment--
Conical connectors: Part 1:
Cones and sockets.
[[Page 15767]]
1-69.................................. .............. ASTM F 1464-93 (Reapproved Contact person.
2005) Standard Specification
for Oxygen Concentrators for
Domiciliary Use.
1-70.................................. .............. ASTM F 1246-91 (Reapproved Contact person.
2005) Standard Specification
for Electrically Powered Home
Care Ventilators, Part 1--
Positive-Pressure Ventilators
and Ventilator Circuits.
1-72.................................. .............. ISO 10651-5 First edition 2006- Contact person.
02-01 Lung ventilators for
medical use--Particular
requirements for basic safety
and essential performance--
Part 5: Gas-powered emergency
resuscitators.
1-73.................................. .............. ISO 10651-4 First edition 2002- Contact person.
03-01 Lung ventilators--Part
4: Particular requirements
for operator-powered
resuscitators.
1-75.................................. .............. ISO 5362 Fourth edition 2006- Contact person.
06-01 Anaesthetic reservoir
bags.
1-79.................................. .............. ISO 26825 First edition 2008- Contact person.
08-15 Corrected version 2009-
09-15 Anaesthetic and
respiratory equipment--User-
applied labels for syringes
containing drugs used during
anaesthesia--Colours, design
and performance.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-87.................................. 2-174 ISO 10993-10 Third Edition Withdrawn and replaced
2010-08-01 Biological with newer version.
evaluation of medical
devices--Part 10: Tests for
irritation and skin
sensitization.
2-93.................................. .............. ASTM F763-04 (Reapproved 2010) Reaffirmation.
Standard Practice for Short-
Term Screening of Implant
Materials.
2-94.................................. .............. ASTM F981-04 (Reapproved 2010) Reaffirmation.
Standard Practice for
Assessment of Compatibility
of Biomaterials for Surgical
Implants with Respect to
Effect of Materials on Muscle
and Bone.
2-108................................. .............. ASTM F1905-98 Standard Withdrawn.
Practice for Selecting Tests
for Determining the
Propensity of Materials to
Cause Immunotoxicity.
2-114................................. .............. ASTM F1877-05 (Reapproved Reaffirmation.
2010) Standard Practice for
Characterization of Particles.
2-117................................. .............. ANSI/AAMI/ISO 10993- Extent of recognition
3:2003(R)2009 Biological and Contact person.
evaluation of medical
devices--Part 3: Tests for
genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-118................................. .............. ANSI/AAMI/ISO 10993-11:2006/ Reaffirmation.
(R)2010 Biological evaluation
of medical devices--Part 11:
Tests for systemic toxicity.
2-120................................. .............. ANSI/AAMI/ISO 10993-6:2007/ Reaffirmation.
(R)2010 Biological evaluation
of medical devices--Part 6:
Tests for local effects after
implantation.
2-126................................. .............. ASTM F748-06 (Reapproved 2010) Reaffirmation.
Standard Practice for
Selecting Generic Biological
Test Methods for Materials
and Devices.
2-134................................. .............. ASTM F2065-00 (Reapproved Reaffirmation.
2010) Standard Practice for
Testing for Alternative
Pathway Complement Activation
in Serum by Solid Materials.
2-155................................. .............. ASTM F2147-01 (Reapproved Reaffirmation.
2010) Standard Practice for
Guinea Pig: Split Adjuvant
and Closed Patch Testing for
Contact Allergens.
2-157................................. 2-184 USP34-NF29:2011<87> Biological Withdrawn and replaced
Reactivity Tests, In Vitro-- with newer version.
Direct Contact Test.
2-158................................. 2-185 USP 34-NF29:2011 Biological Withdrawn and replaced
Tests <87> Biological with newer version.
Reactivity Test, In Vitro--
Elution Test.
2-159................................. 2-186 USP 34-NF29:2011 Biological Withdrawn and replaced
Tests <88> Biological with newer version.
Reactivity Tests, In Vivo,
Procedure Preparation of
Sample.
2-160................................. 2-187 USP 34-NF29:2011 Biological Withdrawn and replaced
Tests <88> Biological with newer version.
Reactivity Test, In Vitro,
Classification of Plastics--
Intracutaneous Test.
2-161................................. 2-188 USP 34-NF29:2011 Biological Withdrawn and replaced
Tests <88> Biological with newer version.
Reactivity Tests, In Vivo
Classification of Plastics--
Systemic Injection Test.
2-165................................. .............. ANSI/AAMI/ISO 10993-14:2001 Reaffirmation.
(Reapproved 2006) Biological
evaluation of medical
devices--Part 14:
Identification and
quantification of degradation
products from ceramics.
2-166................................. 2-180 ANSI/AAMI/ISO 10993-16:2010 Withdrawn and replaced
Biological evaluation of with newer version.
medical devices--Part 16:
Toxicokinetic study design
for degradation products and
leachables.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-52.................................. .............. ANSI/AAMI EC12:2000/(R)2010 Reaffirmation.
Disposable ECG electrodes.
3-61.................................. 3-95 IEC 60601-2-27 Edition 3.0 Newer version with
2011-03 Medical electrical transition period.
equipment--Part 2-27:
Particular requirements for
the basic safety and
essential performance of
electrocardiographic
monitoring equipment.
----------------------------------------------------------------------------------------------------------------
[[Page 15768]]
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-76.................................. .............. ISO 7785-2 Second edition 1995- Contact person.
08-01 Dental handpieces--Part
2: Straight and geared angle
handpieces.
4-83.................................. .............. ISO 11498 First edition 1997- Contact person.
02-15 Dental handpieces--
Dental low-voltage electrical
motors.
4-84.................................. .............. ISO 13294 First edition 1997- Contact person.
05-01 Dental handpieces--
Dental air-motors.
4-90.................................. .............. ANSI S3.39 Reaffirmed by ANSI Contact person.
May 18, 2007 Specifications
for Instruments to Measure
Aural Acoustic Impedance and
Admittance (Aural Acoustic
Immittance).
4-119................................. .............. ANSI/ADA Specification No. 82- Reaffirmation.
1998 (R2009) Reversible/
Irreversible Hydrocolloid
Impression Material Systems.
4-121................................. .............. ISO 7494-2 First edition 2003- Contact person.
03-01 Dentistry--Dental
units--Part 2: Water and air
supply.
4-123................................. .............. ANSI/ASA S3.6-2004 Contact person.
Specification for Audiometers.
4-126................................. .............. ISO 10477 Second edition 2004- Contact person.
10-01 Dentistry--Polymer-
based crown and bridge
materials.
4-134................................. .............. ISO 7494-1 First edition 2004- Contact person.
08-15 Dentistry--Dental
units--Part 1: General
requirements and test methods.
4-136................................. .............. ASTM Designation: F2504-05 Contact person.
Standard Practice for
Describing System Output of
Implantable Middle Ear
Hearing Devices.
4-150................................. .............. ANSI/ADA Specification No. 19- Contact person.
2003 Dental Elastometric
Impression Material:2003.
4-154................................. .............. ISO 4823 Third edition 2000-12- Contact person.
15 Dentistry--Elastometric
impression materials.
4-155................................. .............. ISO 4823:2000 Technical Contact person.
Corrigendum 1 Published 2004-
07-15 Dentistry--Elastomeric
impression materials.
4-156................................. .............. ISO 4823 Third edition 2000-12- Contact person.
15 Amendment 1 2007-07-01
Dentistry--Elastometric
impression materials.
4-160................................. .............. ANSI S3.1-1999 (Reaffirmed by Contact person.
ANSI October 28, 2008)
American National Standard
Maximum Permissible Ambient
Noise Levels for Audiometric
Test Rooms.
4-162................................. .............. ANSI S3.4-2007 American Contact person.
National Standard Procedure
for the Computation of
Loudness of Steady Sounds.
4-163................................. .............. ANSI S3.5-1997 (R1986) Contact person.
Reaffirmed by ANSI May 18,
2007 American National
Standard Methods for
Calculation of the Speech
Intelligibility Index.
4-164................................. .............. ANSI S3.7-1995 (Reaffirmed by Contact person.
ANSI October 28, 2008)
American National Standard
Method for Coupler
Calibration of Earphones.
4-165................................. .............. ANSI S3.13-1987 Reaffirmed by Contact person.
ANSI June 1, 2007 American
National Standard Mechanical
Coupler for Measurement of
Bone Vibrators.
4-170................................. .............. ANSI S3.36-1985 Reaffirmed by Contact person.
ANSI on 4/27/2006 American
National Standard
Specification for a Manikin
for Simulated in-situ
Airborne Acoustic
Measurements.
4-171................................. .............. ANSI S3.37-1987 (Reaffirmed by Contact person.
ANSI May 18, 2007) American
National Standard Preferred
Earhook Nozzle Thread for
Postauricular Hearing Aids.
4-172................................. .............. ANSI S3.42-1992 Reaffirmed by Contact person.
ANSI May 18, 2007 American
National Standard Testing
Hearing Aids with a Broad-
Band Noise Signal.
4-173................................. .............. ANSI S3.44-1996 Reaffirmed by Contact person.
ANSI on 27 April 2006
American National Standard
Determination of Occupational
Noise Exposure and Estimation
of Noise-Induced Hearing
Impairment.
4-175................................. .............. ANSI S3.46-1997 American Contact person.
National Standard Methods of
Measurement of Real-Ear
Performance Characteristics
of Hearing Aids.
4-177................................. .............. ANSI S12.65-2006 (Reaffirmed Reaffirmation.
by ANSI March 30, 2011)
American National Standard
For Rating Noise with Respect
to Speech Interference.
4-179................................. .............. ISO 7405 Second edition 2008- Contact person.
12-15 Dentistry--Evaluation
of biocompatibility of
medical devices used in
dentistry.
4-180................................. .............. ISO 9168 Third edition 2009-07- Contact person.
15 Dentistry--Hose connectors
for air driven dental
handpieces.
4-183................................. .............. ANSI S3.2-2009 American Contact person.
National Standard Method for
Measuring the Intelligibility
of Speech over Communication
Systems.
4-184................................. .............. ANSI/ASA S3.25-2009 American Contact person.
National Standard For an
Occluded Ear Simulator.
4-185................................. .............. ANSI/ASA S3.45-2009 American Contact person.
National Standard Procedures
for Testing Basic Vestibular
Function.
[[Page 15769]]
4-186................................. .............. ANSI/ASA S12.2-2008 American Contact person.
National Standard Criteria
for Evaluating Room Noise.
4-190................................. .............. ANSI/ASA S3.35-2010 American Contact person.
National Standard Method of
Measurement of Performance
Characteristics of Hearing
Aids Under Simulated Real-Ear
Working Conditions.
4-192................................. .............. ANSI/ADA Specification No. 58- Contact person.
2010 Root Canal Files Type H
(Hedstrom): 2007.
----------------------------------------------------------------------------------------------------------------
E. General
----------------------------------------------------------------------------------------------------------------
5-29.................................. .............. AAMI/ANSI HE74-2001 (R 2009) Withdrawn, see 5-67.
Human factors design process
for medical devices.
5-39.................................. .............. IEC 60812 Second edition 2006- Contact person.
01 Analysis techniques for
system reliability--Procedure
for failure mode and effects
analysis (FMEA).
5-40.................................. .............. ISO 14971 Second edition 2007- Contact person.
03-01 Medical devices--
Application of risk
management to medical devices.
5-42.................................. .............. ASTM D903-98 (Reapproved 2010) Reaffirmation.
Standard Test Methods for
Peel or Stripping Strength of
Adhesive Bonds.
5-58.................................. .............. IEC 60601-1-11 Edition Extent of recognition
1.0:2010 Medical electrical and relevant guidance.
equipment--Part 1-11: General
requirements for basic safety
and essential performance--
Collateral Standard:
Requirements for medical
electrical equipment and
medical electrical systems
used in the home healthcare
environment.
----------------------------------------------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-117................................. .............. ASTM F2172-02(2011) Standard Reaffirmation and
Specification for Blood/ Contact person.
Intravenous Fluid/Irrigation
Fluid Warmers.
6-161................................. .............. ISO 10555-1 First edition 1995- Title and Contact
06-15 Sterile, Single-use person.
intravascular catheters--Part
1: General requirements.
6-164................................. .............. ISO 10555-5 First edition 1996- Title and Contact
06-15 Sterile, single-use person.
intravascular catheters--Part
5: Over-needle peripheral
catheters.
6-164................................. 6-266 ISO 10555-5 First edition 1996- See 6-164.
06-15 AMENDMENT 1 1999-01-15
Corrected and reprinted 1999-
07-15 Sterile, single-use
intravascular catheters--Part
5: Over-needle peripheral
catheters.
6-164................................. 6-267 ISO 10555-5:1996 TECHNICAL See 6-164.
CORRIGENDUM 1 Published 2002-
06-15 Sterile, single-use
intravascular catheters--Part
5: Over-needle peripheral
catheters TECHNICAL
CORRIGENDUM.
6-176................................. .............. ASTM D7103-06 \1\ Standard Editorial change.
Guide for Assessment of
Medical Gloves.
6-177................................. .............. ASTM E1112-00 (Reapproved Reaffirmation.
2011) Standard Specification
for Electronic Thermometer
for Intermittent
Determination of Patient
Temperature.
6-198................................. 6-254 ASTM F2100-11, Standard Withdrawn and replaced
Specification for Performance with newer version.
of Materials Used in Medical
Face Masks.
6-203................................. .............. ASTM D6499-07, Standard Test Extent of recognition.
Method for The Immunological
Measurement of Antigenic
Protein in Natural Rubber and
its Products.
6-219................................. 6-255 USP 34-NF 29<11>:2011 Sodium Withdrawn and replaced
Chloride Irrigation. with newer version.
6-226................................. 6-256 USP 34-NF 29<11>:2011 Sodium Withdrawn and replaced
Chloride Injection. with newer version.
6-246................................. 6-257 USP 34-NF 29 2011 Withdrawn and replaced
Nonabsorbable Surgical Suture. with newer version.
6-248................................. 6-258 USP 34-NF 29 2011 <881> Withdrawn and replaced
Tensile Strength. with newer version.
6-249................................. 6-259 USP 34-NF 29 2011 <861> Withdrawn and replaced
Sutures Diameter. with newer version.
6-250................................. 6-260 USP 34-NF 29 2011 <871> Withdrawn and replaced
Sutures--Needle. with newer version.
6-251................................. 6-261 USP 34-NF 29 <11>:2011 Sterile Withdrawn and replaced
Water for Irrigation. with newer version.
6-252................................. 6-262 USP 34-NF 29 <11>:2011 Heparin Withdrawn and replaced
Lock Flush Solution. with newer version.
----------------------------------------------------------------------------------------------------------------
G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-102................................. 7-221 CLSI H01-A6 Tubes and Withdrawn and replaced
Additives for Venous and with newer version.
Capillary Blood Specimen
Collection; Approved
Standard--Sixth Edition.
7-112................................. .............. CLSI H49-A Point-of-Care Withdrawn duplicate, see
Monitoring of Anticoagulation 7-162.
Therapy; Approved Guideline.
[[Page 15770]]
7-126................................. 7-222 CLSI M24-A2 Susceptibility Withdrawn and replaced
Testing of Mycobacteria, with newer version
Nocardiae, and Other Aerobic Contact person.
Actinomycetes; Approved
Standards--Second Edition.
7-128................................. .............. CLSI EP14-A2 Evaluation of Withdrawn duplicate, see
Matrix Effects; Approved 7-143.
Guideline--Second Edition.
7-130................................. .............. CLSI H20-A2 Reference Withdrawn duplicate, see
Leukocyte (WBC) Differential 7-165.
Count (Proportional) and
Evaluation of Instrumental
Methods; Approved Standard--
Second Edition.
7-134................................. .............. CLSI GP20-A2 Fine Needle Withdrawn duplicate, see
Aspiration Biopsy (FNAB) 7-166.
Techniques; Approved
Guideline--Second Edition.
7-140................................. 7-223 GP22-A3--Quality Management Withdrawn and replaced
System: Continual with newer version.
Improvement; Approved
Guideline--Third Edition.
7-143................................. .............. CLSI EP14-A2 Evaluation of Contact person, Type of
Matrix Effects; Approved standard, Processes
Guideline--Second Edition. impacted.
7-147................................. .............. CLSI M22-A3 Quality Control Withdrawn duplicate, see
for Commercially Prepared 7-178.
Microbiological Culture
Media; Approved Standard--
Third Edition.
7-150................................. .............. CLSI H43-A2 Clinical Flow Title, Contact person.
Cytometric Analysis of
Neoplastic Hematolymphoid
Cells; Approved Guideline--
Second Edition.
7-162................................. .............. CLSI H49-A Point-of-Care Contact person, Devices
Monitoring of Anticoagulation affected, Processes
Therapy; Approved Guideline. affected, Type of
standard, CFR citation
and product codes.
7-165................................. .............. CLSI H20-A2 Reference Contact person, Devices
Leukocyte (WBC) Differential affected, Processes
Count (Proportional) and affected, Type of
Evaluation of Instrumental standard, CFR citation
Methods; Approved Standard-- and product codes.
Second Edition.
7-166................................. .............. CLSI GP20-A2 Fine Needle Devices affected,
Aspiration Biopsy (FNAB) Process affected, CFR
Techniques; Approved citation and product
Guideline--Second Edition. codes.
7-169................................. .............. CLSI M27-A3 Reference Method Withdrawn duplicate, see
for Broth Dilution Antifungal 7-204.
Susceptibility Testing of
Yeasts; Approved Standard--
Third Edition.
7-172................................. .............. CLSI C28-A3 Defining, Withdrawn duplicate, see
Establishing, and Verifying 7-224.
Reference Intervals in the
Clinical Laboratory; Approved
Guideline--Third Edition.
7-202................................. 7-224 CLSI C28-A3c Defining, Withdrawn and replaced
Establishing, and Verifying with newer version.
Reference Intervals in the
Clinical Laboratory; Approved
Guideline--Third Edition.
7-178................................. .............. CLSI M22-A3 Quality Control Extent of recognition,
for Commercially Prepared CFR citation and
Microbiological Culture product codes.
Media; Approved Standard--
Third Edition.
7-204................................. .............. CLSI M27-A3 Reference Method Contact person.
for Broth Dilution Antifungal
Susceptibility Testing of
Yeasts; Approved Standard--
Third Edition.
7-206................................. .............. CLSI I/LA 20-A2 Analytical Title, Contact person.
Performance Characteristics
and Clinical Utility of
Immunological Assays for
Human Immunoglobulin E (IgE)
Antibodies and Defined
Allergen Specificities;
Approved Guideline--Second
Edition.
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
11-219................................ 8-203 ASTM F2026-08 Standard Transferred.
Specification for
Polyetheretherketone (PEEK)
Polymers for Surgical Implant
Applications.
8-101................................. 8-204 ASTM F2118-10 Standard Test Withdrawn and replaced
Method for Constant Amplitude with newer version.
of Force Controlled Fatigue
Testing of Acrylic Bone
Cement Materials.
8-105................................. 8-205 ASTM F1635-11 Standard Test Withdrawn and replaced
Method for in vitro with newer version.
Degradation Testing of
Hydrolytically Degradable
Polymer Resins and Fabricated
Forms for Surgical Implants.
8-114................................. .............. ASTM F2255-05 (Reapproved Reaffirmation.
2010) Standard Test Method
for Strength Properties of
Tissue Adhesives in Lap-Shear
by Tension Loading.
8-115................................. .............. ASTM F2256-05 (Reapproved Reaffirmation.
2010) Standard Test Method
for Strength Properties of
Tissue Adhesives in T-Peel by
Tension Loading.
8-116................................. .............. ASTM F2258-05 (Reapproved Reaffirmation.
2010) Standard Test Method
for Strength Properties of
Tissue Adhesives in Tension.
8-119................................. 8-206 ASTM F688-10 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-35 Nickel-20 Chromium-
10 Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035).
8-121................................. .............. ASTM F2005-05 (Reapproved Reaffirmation.
2010) Standard Terminology
for Nickel-Titanium Shape
Memory Alloys.
8-125................................. .............. ASTM F2004-05 (Reapproved Reaffirmation.
2010) Standard Test Method
for Transformation
Temperature of Nickel-
Titanium Alloys by Thermal
Analysis.
[[Page 15771]]
8-126................................. .............. ASTM F561-05a (Reapproved Reaffirmation.
2010) Standard Practice for
Retrieval and Analysis of
Medical Devices, and
Associated Tissues and Fluids.
8-132................................. .............. ASTM F1088-04a (Reapproved Reaffirmation and
2010) Standard Specification contact person.
for Beta-Tricalcium Phosphate
for Surgical Implantation.
8-135................................. .............. ASTM F2392-04 (Reapproved Reaffirmation.
2010) Standard Test Method
for Burst Strength of
Surgical Sealants.
8-136................................. .............. ASTM F2458-05 (Reapproved Reaffirmation.
2010) Standard Test Method
for Wound Closure Strength of
Tissue Adhesives and Sealants.
8-172................................. 8-207 ASTM F1926/F1926M-10 Standard Withdrawn and replaced
Test Method for Evaluation of with newer version.
the Environmental Stability
of Calcium Phosphate
Granules, Fabricated Forms,
and Coatings.
8-178................................. 8-208 ASTM F648-10a Standard Withdrawn and replaced
Specification for Ultra-High- with newer version.
Molecular-Weight Polyethylene
Powder and Fabricated Form
for Surgical Implants.
8-181................................. 8-209 ASTM F899-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Stainless Steels for Surgical
Instruments.
8-191................................. 8-210 ASTM F2182-11 Standard Test Withdrawn and replaced
Method for Measurement of with newer version.
Radio Frequency Induced
Heating On or Near Passive
Implants During Magnetic
Resonance Imaging.
8-195................................. .............. ASTM F2024-10, Standard Extent of Recognition,
Practice for X-Ray devices affected, CFR
Diffraction Determination of citations and
Phase Content of Plasma- associated procodes and
Sprayed Hydroxyapatite contact person.
Coatings.
----------------------------------------------------------------------------------------------------------------
I. Neurology
----------------------------------------------------------------------------------------------------------------
17-1.................................. .............. ANSI/AAMI NS28:1988/(R) 2010 Reaffirmation.
Intracranial pressure
monitoring devices.
17-3.................................. .............. ISO 7197:2006 Third edition Contact person.
2006-06-01 Neurosurgical
implants--Sterile, single-use
hydrocephalus shunts and
components.
17-4.................................. .............. ASTM F 647-94 (Reapproved Contact person.
2006) Standard Practice for
Evaluating and Specifying
Implantable Shunt Assemblies
for Neurosurgical Application.
17-7.................................. .............. ISO 7197:2006 Technical Contact person.
Corrigendum 1 Published:2007-
07-01 Neurological implants--
Sterile, single-use
hydrocephalus shunts and
components.
----------------------------------------------------------------------------------------------------------------
J. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-21.................................. .............. ISO 8600-4 First edition 1997- Contact person.
07-01 Optics and optical
instruments--Medical
endoscopes and certain
accessories--Part 4:
Determination of maximum
width of insertion portion.
9-37.................................. .............. ISO 8600-1 Second edition 2005- Contact person.
05-01 Optics and photonics--
Medical endoscopes and
endotherapy devices--Part 1:
General requirements.
9-38.................................. .............. ISO 8600-3 First edition 1997- Contact person.
07-01 AMENDMENT 1 2003-12-01
Optics and optical
instruments--Medical
endoscopes and endoscopic
accessories Part 3:
Determination of field of
view and direction of view of
endoscopes with optics.
9-39.................................. .............. ISO 8600-5 First edition 2005- Contact person.
03-15 Optics and photonics--
Medical endoscopes and
endotherapy devices--Part 5:
Determination of optical
resolution of rigid
endoscopes with optics.
9-40.................................. .............. ISO 8600-6 First edition 2005- Contact person.
03-15 Optics and photonics--
Medical endoscopes and
endotherapy devices--Part 6:
Vocabulary.
9-44.................................. .............. ASTM Designation: F 623-99 Contact person.
(Reapproved 2006) Standard
Performance Specification for
Foley Catheter.
9-49.................................. .............. AAMI/ANSI RD61:2006, Withdrawn, see 9-73.
Concentrates for hemodialysis.
9-50.................................. .............. ANSI/AAMI RD52:2004/(R)2010 Withdrawn, see 9-70 and
Dialysate for Hemodialysis. 9-71.
9-53.................................. .............. ASTM F 1992-99 (Reapproved Contact person.
2007) Standard Practice for
Reprocessing of Reusable,
Heat-Stable Endoscopic
Accessory Instruments (EAI)
Used with Flexible Endoscopes.
9-55.................................. .............. AAMI/ANSI RD62:2006 and ANSI/ Withdrawn, see 9-69.
AAMI RD62:2006/A1:2009, Water
treatment equipment for
hemodialysis applications.
9-61.................................. .............. IEC 60601-2-18 Edition 3.0 Contact person.
2009-08 Medical electrical
equipment--Part 2-18:
Particular requirements for
the basic safety and
essential performance of
endoscopic equipment.
9-59.................................. .............. AAMI/ANSI RD5:2003/(R)2008, Withdrawn, see 9-72.
Hemodialysis.
----------------------------------------------------------------------------------------------------------------
[[Page 15772]]
K. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-15................................. .............. ISO 9394 Second edition 1998- Contact person.
08-15 Ophthalmic optics--
Contact lenses and contact
lens care products--
Determination of
biocompatibility by ocular
study using rabbit eyes.
10-24................................. 10-67 ISO 11986 Second edition 2010- Withdrawn and replaced
11-01 Ophthalmic optics-- with newer version.
Contact lenses and contact
lens care products--
Determination of preservative
uptake and release.
10-26................................. 10-68 ISO 13212 Second edition 2011- Withdrawn and replaced
05-15 Ophthalmic optics-- with newer version.
Contact lens care products--
Guidelines for determination
of shelf-life.
10-28................................. .............. ISO 14729 First edition 2001- Contact person.
04-15 Ophthalmic optics--
Contact lens care products--
Microbiological requirements
and test methods for products
and regimens for hygienic
management of contact lenses.
10-29................................. .............. ISO 14730 First edition 2000- Contact person.
09-15 Ophthalmic optics--
Contact lens care products--
Antimicrobial preservative
efficacy testing and guidance
on determining discard date.
10-33................................. 10-69 ANSI Z80.18-2010 for Withdrawn and replaced
Ophthalmics--Contact Lens with newer version.
Care Products--Vocabulary,
Performance Specifications,
and Test Methodology.
10-38................................. 10-70 ISO 10943 Third edition 2011- Withdrawn and replaced
08-15 Ophthalmic instruments-- with newer version.
Indirect ophthalmoscopes.
10-59................................. .............. ISO 11980 Second edition 2009- Contact person.
10-15 Ophthalmic optics--
Contact lenses and contact
lens care products--Guidance
for clinical investigations.
----------------------------------------------------------------------------------------------------------------
L. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-167................................ 11-226 ASTM F1089-10 Standard Test Withdrawn and replaced
Method for Corrosion of with newer version.
Surgical Instruments.
11-180................................ 11-227 ASTM F366-10 Standard Withdrawn and replaced
Specification for Fixation with newer version;
Pins and Wires. change contact.
11-196................................ .............. ASTM F1672-95 (Reapproved Reaffirmation.
2011) Standard Specification
for Resurfacing Patellar
Prosthesis.
11-201................................ 11-228 ASTM F564-10 Standard Withdrawn and replaced
Specification and Test with newer version.
Methods for Metallic Bone
Staples.
11-217................................ 11-229 ASTM F2083-10 Standard Withdrawn and replaced
Specification for Total Knee with newer version.
Prosthesis.
11-221................................ 11-230 ASTM F1717-10 Standard Test Withdrawn and replaced
Methods for Spinal Implant with newer version.
Constructs in a Vertebrectomy
Model.
11-155................................ 11-231 ISO 7207-2 Second edition 2011- Withdrawn and replaced
07-01 Implants for surgery-- with newer version.
Components for partial and
total knee joint prostheses--
Part 2: Articulating surfaces
made of metal, ceramic and
plastics materials.
11-219................................ 8-203 ASTM F2026-10 Standard Transferred and replaced
Specification for with a newer version.
Polyetheretherketone (PEEK)
Polymers for Surgical Implant
Applications.
----------------------------------------------------------------------------------------------------------------
M. Radiology
----------------------------------------------------------------------------------------------------------------
12-52................................. .............. UL 544 (1998), Standard for Withdrawn, see 5-4 and 5-
Medical and Dental Equipment-- 52.
Ed. 4.0.
12-62................................. .............. UL 187 (1998), Standard for X- Withdrawn, see 5-4 and 5-
ray Equipment--Ed. 7.0. 52.
12-100................................ .............. NEMA UD 3-2004 (R2009), Reaffirmation.
Standard for Real Time
Display of Thermal and
Mechanical Acoustic Output
Indices on Diagnostic
Ultrasound Equipment,
Revision 2.
12-105................................ .............. NEMA UD 2-2004 (R2009), Reaffirmation.
Acoustic Output Measurement
Standard for Diagnostic
Ultrasound Equipment,
Revision 3.
12-106................................ .............. ISO 17526 First edition 2003- Contact person.
06-15, Optics and optical
instruments--Lasers and laser-
related equipment--Lifetime
of lasers.
12-108................................ 12-246 ISO 21254-2 First edition 2011- Withdrawn and replaced
07-15 Lasers and laser- with newer version.
related equipment--Test
methods for laser-induced
damage threshold--Part 2:
Threshold determination.
12-109................................ 12-245 ISO 21254-1 First edition 2011- Withdrawn and replaced
07-15 Lasers and laser- with newer version.
related equipment--Test
methods for laser-induced
damage threshold--Part 1:
Definitions and general
principles.
12-110................................ .............. ISO 11551 Second edition 2003- Contact person.
12-01, Optics and optical
instruments--Lasers and laser-
related equipment--Test
method for absorptance of
optical laser components.
12-113................................ .............. ISO 12005 Second edition 2003- Contact person.
04-01, Lasers and laser-
related equipment--Test
methods for laser beam
parameters--Polarization.
12-115................................ .............. ISO 13695 First edition 2004- Contact person.
06-01, Optics and photonics--
Lasers and laser-related
equipment--Test methods for
the spectral characteristics
of lasers.
[[Page 15773]]
12-117................................ .............. ISO 15367-1 First edition 2003- Contact person.
09-15, Lasers and laser-
related equipment--Test
methods for determination of
the shape of a laser beam
wavefront--Part 1:
Terminology and fundamental
aspects.
12-134................................ .............. ISO 11146-1 First edition 2005- Contact person.
01-15, Lasers and laser-
related equipment--Test
methods for laser beam
widths, divergence angles and
beam propagation ratios--Part
1: Stigmatic and simple
astigmatic beams.
12-140................................ .............. AIUM RTD2-2004, Standard for Title.
Real-Time Display of Thermal
and Mechanical Acoustic
Output Indices on Diagnostic
Ultrasound Equipment Revision
2.
12-142................................ .............. ISO 11146-2 First edition 2005- Contact person.
02-15, Lasers and laser-
related equipment--Test
methods for laser beam
widths, divergence angles and
beam propagation ratios--Part
2: General astigmatic beams.
12-143................................ .............. ISO 15367-2 First edition 2005- Contact person.
03-15, Lasers and laser-
related equipment--Test
methods for determination of
the shape of a laser beam
wavefront--Part 2: Shack-
Hartman sensors.
12-144................................ 12-247 ISO 11990-1 First edition 2011- Withdrawn and replaced
08-01 Lasers and laser- with newer version.
related equipment--
Determination of laser
resistance of tracheal tubes--
Part 1: Tracheal tube shaft.
12-154................................ 12-248 ISO 21254-3 First edition 2011- Withdrawn and replaced
07-15 Lasers and laser- with newer version.
related equipment--Test
methods for laser-induced
damage threshold--Part 3:
Assurance of laser power
(energy) handling
capabilities.
12-155................................ .............. ISO 11554 Third edition 2006- Contact person.
05-01, Optics and photonics--
Lasers and laser-related
equipment--Test methods for
laser beam power, energy and
temporal characteristics.
12-156................................ .............. ISO 11670:2003 Technical Contact person.
Corrigendum 1 Published 2004-
05-15, Lasers and laser-
related equipment--Test
methods for laser beam
parameters--Beam positional
stability.
12-157................................ .............. ISO 13694:2000 Technical Contact person.
Corrigendum 1 Published 2005-
11-01, Optics and optical
instruments--Lasers and laser-
related equipment--Test
methods for laser beam power
(energy) density distribution.
12-174................................ .............. ISO 13697 First edition 2006- Contact person.
05-15, Optics and photonics--
Lasers and laser-related
equipment--Test methods for
specular reflectance and
regular transmittance of
optical laser components.
12-175................................ .............. ISO 24013 First edition 2006- Contact person.
11-15, Optics and photonics--
Lasers and laser-related
equipment--Measurement of
phase retardation of optical
components for polarized
laser radiation.
12-177................................ 12-249 ANSI/UL 122-2007 Standard for Withdrawn and replaced
Photographic Equipment--Ed. with newer version.
5.0.
12-125................................ 12-231 NEMA MS 5-2010, Determination Withdrawn and replaced
of Slice Thickness in with newer version.
Diagnostic Magnetic Resonance
Imaging.
12-151................................ 12-232 NEMA MS 4-2010, Acoustic Noise Withdrawn and replaced
Measurement Procedure for with newer version.
Diagnosing Magnetic Resonance
Imaging Devices.
12-160................................ 12-234 NEMA MS 12-2010, Withdrawn and replaced
Quantification and Mapping of with newer version.
Geometric Distortion for
Special Applications.
12-162................................ 12-235 IEC 60731 Edition 3.0 2011-02, Withdrawn and replaced
Amendment 1, Medical with newer version.
electrical equipment--
Dosimeters with ionization
chambers as used in
radiotherapy.
12-178................................ 12-236 IEC 60601-2-45 Edition 3.0 Newer version with
2011-02, Medical electrical transition period.
equipment--Part 2-45:
Particular requirements for
the basic safety and
essential performance of
mammographic X-ray equipment
and mammographic stereotactic
devices.
12-191................................ 12-237 IEC 62359 Edition 2.0 2010-10, Withdrawn and replaced
Ultrasonics--Field with newer version.
characterization--Test
methods for the determination
of thermal and mechanical
indices related to medical
diagnostic ultrasonic fields.
12-218................................ 12-238 NEMA PS 3.1-3.20 (2011), Withdrawn and replaced
Digital Imaging and with newer version.
Communications in Medicine
(DICOM) Set.
----------------------------------------------------------------------------------------------------------------
N. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-11................................. 13-30 CLSI AUTO3-A2 Laboratory Withdrawn and replaced
Automation: Communications with newer version.
with Automated Clinical
Laboratory Systems,
Instruments, Devices, and
Information Systems; Approved
Standard, Second Edition 2009.
----------------------------------------------------------------------------------------------------------------
O. Sterility
----------------------------------------------------------------------------------------------------------------
14-135................................ .............. AAMI/ANSI ST63:2002, Withdrawn, see 14-339.
Sterilization of health care
products--Requirements for
the development, validation
and routine control of an
industrial sterilization
process for medical devices--
Dry heat.
[[Page 15774]]
14-169................................ .............. ASTM F2391-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Measuring Package and
Seal Integrity Using Helium
as the Tracer Gas.
14-170................................ 14-313 ASTM F2475-11 Standard Guide Withdrawn and replaced
for Biocompatibility with newer version.
Evaluation of Medical Device
Packaging Materials.
14-181................................ .............. ANSI/AAMI ST58:2005/(R)2010 Reaffirmation and
Chemical sterilization and contact person.
high-level disinfection in
health care facilities.
14-193................................ .............. ANSI/AAMI/ISO 11607-1:2006/ Reaffirmation.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 1: Requirements
for materials, sterile
barrier systems, and
packaging systems.
14-194................................ .............. ANSI/AAMI/ISO 11607-2:2006/ Reaffirmation.
(R)2010 Packaging for
terminally sterilized medical
devices--Part 2: Validation
requirements for forming,
sealing, and assembly
processes.
14-195................................ .............. ANSI/AAMI/ISO 11140- Reaffirmation, extent of
1:2005(R)2010 Sterilization recognition, and type
of health care products-- of standard.
Chemical indicators--Part 1:
General requirements.
14-201................................ .............. ANSI/AAMI ST77:2006/(R)2010 Reaffirmation and
Containment devices for contact person.
reusable medical device
sterilization.
14-214................................ .............. AOAC 6.2.04:2009 Official Reaffirmation.
Method 955.15, Testing
Disinfectants Against
Staphylococcus aureus, Use--
Dilution Method.
14-216................................ .............. AOAC 6.2.06:2009 Official Reaffirmation.
Method 964.02, Testing
Disinfectants Against
Pseudomonas aeruginosa, Use--
Dilution Method.
14-219................................ .............. AOAC 6.3.06:2008 Official Reaffirmation.
Method 965.12, Tuberculocidal
Activity of Disinfectants.
14-222................................ .............. ANSI/AAMI/ISO 18472:2006/ Reaffirmation, and
(R)2010 Sterilization of contact person.
health care products--
Biological and chemical
indicators--Test equipment.
14-225................................ .............. ANSI/AAMI/ISO 11137-2:2006 Extent of recognition
Sterilization of health care and relevant guidance.
products--Radiation--Part 2:
Establishing the
sterilization dose.
14-227................................ .............. ANSI/AAMI/ISO 11737-1:2006 Extent of recognition
Sterilization of health care and title.
products--Microbiological
methods--Part 1:
Determination of the
population of microorganisms
on product.
14-228................................ .............. ANSI/AAMI/ISO 11135-1:2007 Extent of recognition.
Sterilization of health care
products--Ethylene oxide--
Part 1: Requirements for
development, validation, and
routine control of a
sterilization process for
medical devices.
14-238................................ .............. ANSI/AAMI/ISO 11140-5:2007, Relevant guidance.
Sterilization of health care
products--Chemical
indicators--Part 5: Class 2
indicators for Bowie and Dick-
type air removal tests.
14-261................................ .............. ANSI/AAMI/ISO 17665-1:2006 Extent of recognition,
Sterilization of health care relevant guidance and
products--Moist heat--Part 1: contact person.
Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-274................................ .............. ANSI/AAMI/ISO 15882:2008 Extent of recognition.
Sterilization of health care
products--Chemical
indicators--Guidance for
selection, use, and
interpretation of results.
14-276................................ 14-314 ANSI/AAMI ST67:2011 Withdrawn and replaced
Sterilization of health care with newer version.
products--Requirements and
guidance for selecting a
sterility assurance level
(SAL) for products labeled
``sterile''.
14-285................................ .............. ANSI/AAMI/ISO 14161:2009 Title, contact person.
Sterilization of health care
products--Biological
indicators--Guidance for the
selection, use and
interpretation of results.
14-287................................ .............. ANSI/AAMI/ISO 11737-2:2009 Extent of recognition
Sterilization of medical and title.
devices--Microbiological
methods--Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a
sterilization process.
14-291................................ .............. ANSI/AAMI/ISO 14937:2009 Extent of recognition.
Sterilization of health care
products--General
requirements for
characterization of a
sterilizing agent and the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-295................................ .............. ANSI/AAMI ST81:2004/(R)2010, Relevant guidance and
Sterilization of medical contact person.
devices--Information to be
provided by the manufacturer
for the processing of
resterilizable medical
devices.
14-296................................ .............. ANSI/AAMI/ISO 11138-1:2006/ Extent of recognition,
(R)2010 Sterilization of contact person and
health care products-- relevant guidance.
Biological indicators--Part
1: General requirements.
14-297................................ .............. ANSI/AAMI/ISO 11137-1:2006/ Extent of recognition,
(R)2010 Sterilization of and relevant guidance.
health care products--
Radiation--Part 1:
Requirements for development,
validation, and routine
control of a sterilization
process for medical devices.
14-298................................ .............. ANSI/AAMI/ISO 11137-3:2006/ Extent of recognition
(R)2010 Sterilization of and relevant guidance.
health care products--
Radiation--Part 3: Guidance
on dosimetric aspects.
14-301................................ 14-315 USP 34:2011 <61> Withdrawn and replaced
Microbiological Examination with newer version.
of Nonsterile Products:
Microbial Enumeration Tests.
14-302................................ 14-316 USP 34:2011 <71> Sterility Withdrawn and replaced
Tests. with newer version.
[[Page 15775]]
14-303................................ 14-317 USP 34:2011 <85> Bacterial Withdrawn and replaced
Endotoxins Test. with newer version.
14-304................................ 14-318 USP 34:2011 <151> Pyrogen Test Withdrawn and replaced
(USP Rabbit Test). with newer version.
14-305................................ 14-319 USP 34:2011 <161> Transfusion Withdrawn and replaced
and Infusion Assemblies and with newer version.
Similar Medical Devices.
14-306................................ 14-320 USP 34:2011 Biological Withdrawn and replaced
Indicator for Steam with newer version.
Sterilization--Self Contained.
14-307................................ 14-321 USP 34:2011 Biological Withdrawn and replaced
Indicator for Dry-Heat with newer version.
Sterilization, Paper Carrier.
14-308................................ 14-322 USP 34:2011 Biological Withdrawn and replaced
Indicator for Ethylene Oxide with newer version.
Sterilization, Paper Carrier.
14-309................................ 14-323 USP 34:2011 Biological Withdrawn and replaced
Indicator for Steam with newer version.
Sterilization, Paper Carrier.
14-310................................ 14-324 USP 34:2011 <62> Withdrawn and replaced
Microbiological Examination with newer version.
of Nonsterile Products: Tests
for Specified Microorganisms.
----------------------------------------------------------------------------------------------------------------
P. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-7.................................. 15-27 ASTM F2315-11 Standard Guide Withdrawn and replaced
for Immobilization or with newer version.
Encapsulation of Living Cells
or Tissue in Alginate Gels.
15-8.................................. .............. ASTM F2064-00 (Reapproved Editorial change.
2006) \1\ Standard Guide for
Characterization and Testing
of Alginates as Starting
Materials Intended for Use in
Biomedical and Tissue-
Engineered Medical Products
Application.
15-10................................. .............. ASTM F2451-05 (Reapproved Reaffirmation.
2010) Standard Guide for in
vivo Assessment of
Implantable Devices Intended
to Repair or Regenerate
Articular Cartilage.
15-12................................. 15-28 ASTM F2103-11 Standard Guide Withdrawn and replaced
for Characterization and with newer version.
Testing of Chitosan Salts as
Starting Materials Intended
for Use in Biomedical and
Tissue-Engineered Medical
Product Applications.
15-15................................. 15-29 ASTM F2259-10 Standard Test Withdrawn and replaced
Method for Determining the with newer version.
Chemical Composition and
Sequence in Alginate by
Proton Nuclear Magnetic
Resonance (1H NMR)
Spectroscopy.
15-18................................. 15-30 ASTM F2212-11 Standard Guide Withdrawn and replaced
for Characterization of Type with newer version.
I Collagen as Starting
Material for Surgical
Implants and Substrates for
Tissue Engineered Medical
Products (TEMPs).
15-25................................. 15-31 ASTM F2312-11 Standard Withdrawn and replaced
Terminology Relating to with newer version.
Tissue Engineered Medical
Products.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 028.
Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference
Recognition No. Title of standard \1\ Number and date
------------------------------------------------------------------------
A. Biocompatibility
------------------------------------------------------------------------
2-173......................... Biological evaluation ANSI/AAMI/ISO
of medical devices-- 10993-10:2010.
Part 10: Tests for
irritation and skin
sensitization.
2-175......................... Biological evaluation ISO 10993-3
of medical devices Second edition
Part 3: Tests for 2003-10-15.
genotoxicity,
carcinogenicity and
reproductive toxicity.
2-176......................... Biological evaluation ISO 10993-11
of medical devices Second edition
Part 11: Tests for 2006-08-15.
systemic toxicity.
2-177......................... Biological evaluation ISO 10993-6
of medical devices-- Second edition
Part 6: Tests for 2007-04-15.
local effects after
implantation.
2-178......................... Biological evaluation ISO 10993-12
of medical devices-- Third edition
Part 12: Sample 2007-11-15
preparation and Corrected
reference materials. version 2008-02-
15.
2-179......................... Biological evaluation ISO 10993-1
of medical devices-- Fourth edition
Part 1: Evaluation 2009-10-15.
and testing within a
risk management
process.
2-181......................... Clinical investigation ANSI/AAMI/ISO
of medical devices 14155:2011.
for human subjects--
Good clinical
practice.
[[Page 15776]]
2-182......................... Clinical investigation ISO 14155 Second
of medical devices edition 2011-02-
for human subjects-- 01.
Good clinical
practice.
2-183......................... Clinical investigation ISO 14155: 2011
of medical devices Technical
for human subjects-- Corrigendum 1
Good clinical Published 2011-
practice TECHNICAL 07-15.
CORRIGENDUM 1.
------------------------------------------------------------------------
B. Cardiovascular
------------------------------------------------------------------------
3-96.......................... Non-invasive ISO 81060-1
sphygmomanometers--Pa First edition
rt 1: Requirements 2007-12-01.
and test methods for
non-automated
measurement type.
3-97.......................... Non-invasive ISO 81060-2
sphygmomanometers--Pa First edition
rt 2: Clinical 2009-05-01.
validation of
automated measurement
type.
3-98.......................... Non-invasive ISO 81060-2:2009
sphygmomanometers--Pa TECHNICAL
rt 2: Clinical CORRIGENDUM 1
validation of Published 2011-
automated measurement 02-15.
type TECHNICAL
CORRIGENDUM 1.
3-99.......................... Evaluation of AAMI TIR42:2010.
particulates
associated with
vascular medical
devices.
3-100......................... Medical electrical ANSI/AAMI/IEC
equipment--Part 2-27: 60601-2-27:2011
Particular .
requirements for the
basic safety and
essential performance
of
electrocardiographic
monitoring equipment.
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
5-68.......................... Medical devices-- ANSI/AAMI/ISO
Symbols to be used 15223-2:2010.
with medical device
labels, labelling,
and information to be
supplied--Part 2:
Symbol development,
selection and
validation.
5-69.......................... Medical electrical IEC 60601-1-11
equipment--Part 1-11: (First edition--
General requirements 2010) April
for basic safety and 2011.
essential
performance--Collater
al Standard:
Requirements for
medical electrical
equipment and medical
electrical systems
used in the home
healthcare
environment
Corrigendum 1.
5-70.......................... Medical devices-- ANSI/AAMI/ISO
Application of risk 14971:2007/
management to medical (R)2010.
devices.
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-263......................... Absorbable Surgical USP 34-NF 28
Suture. 2011.
6-264......................... Sterile, single-use ISO 10555-1
intravascular First edition
catheters--Part 1: 1995-06-15
General requirements. Amendment 1
1999-07-15.
6-265......................... Sterile, single-use ISO 10555-1
intravascular First edition
catheters--Part 1: 1995-06-15
General requirements. AMENDMENT 2
2004-05-15.
6-268......................... Standard Terminology ASTM F921--10
Relating to (Reapproved
Hemostatic Forceps. 2011).
6-269......................... Standard Terminology ASTM F1078--10
for Surgical (Reapproved
Scissors--Inserted 2011).
and Non-Inserted
Blades.
6-270......................... Standard Terminology ASTM F1840-10
for Surgical Suture \1\.
Needles.
6-271......................... Standard Test Method ASTM F1874--98
for Bend Testing of (Reapproved
Needles Used in 2011).
Surgical Sutures.
6-272......................... Standard Specification ASTM F2062--00
for Square Drive (Reapproved
Interconnections on 2011).
Surgical Instruments.
6-273......................... Sharps injury ISO 23908 First
protection--Requireme edition 2011-06-
nts and test methods-- 11.
Sharps protection
features for single-
use hypodermic
needles, introducers
for catheters and
needles used for
blood sampling.
------------------------------------------------------------------------
E. In Vitro Diagnostics
------------------------------------------------------------------------
7-225......................... Validation and CLSI GP34-A.
Verification of Tubes
for Venous and
Capillary Blood
Specimen Collection;
Approved Guideline.
7-226......................... Quality Management CLSI GP26-A4.
System: A Model for
Laboratory Services;
Approved Guideline--
Fourth Edition.
7-227......................... Criteria for CLSI M53-A.
Laboratory Testing
and Diagnosis of
Human
Immunodeficiency
Virus Infection;
Approved Guideline.
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
8-211......................... Implants for surgery-- ISO 5834-1 Third
Ultra-high-molecular- edition 2005-06-
weight polyethylene-- 01.
Part 1: Powder form.
[[Page 15777]]
8-212......................... Implants for surgery-- ISO 5834-1:2005
Ultra-high-molecular- TECHNICAL
weight polyethylene-- CORRIGENDUM 1
Part 1: Powder form Published 2007-
TECHNICAL CORRIGENDUM 05-01.
1.
8-213......................... Implants for surgery-- ISO 5834-3 First
Ultra-high-molecular- edition 2005-07-
weight polyethylene-- 15.
Part 3: Accelerated
ageing methods.
8-214......................... Implants for surgery-- ISO 5834-4 First
Ultra-high molecular edition 2005-05-
weight polyethylene-- 01.
Part 4: Oxidation
index measurement
method.
8-215......................... Implants for surgery-- ISO 5834-5 First
Ultra-high-molecular- edition 2005-06-
weight polyethylene-- 01.
Part 5: Morphology
assessment method.
------------------------------------------------------------------------
G. Neurology
------------------------------------------------------------------------
17-9.......................... Implants for surgery-- ANSI/AAMI/ISO
Active implantable 14708-3:2008.
medical devices Part
3: Implantable
neurostimulators.
------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-69.......................... Water for hemodialysis ANSI/AAMI/ISO
and related therapies. 13959:2009.
9-70.......................... Guidance for the ANSI/AAMI/ISO
preparation and 23500:2011.
quality management of
fluids for
hemodialysis and
related therapies.
9-71.......................... Quality of dialysis ANSI/AAMI/ISO
fluid for 11663:2009.
hemodialysis and
related therapies.
9-72.......................... Medical electrical ANSI/AAMI/IEC
equipment, Part 2-16: 60601-2-16:2008
Particular .
requirements for
basic safety and
essential performance
of hemodialysis,
hemodiafiltration and
hemofiltration
equipment.
9-73.......................... Concentrates for ANSI/AAMI/ISO
haemodialysis and 13958:2009.
related therapies.
9-74.......................... Concentrates for ISO 13958 Second
haemodialysis and edition 2009-4-
related therapies. 15.
------------------------------------------------------------------------
I. Ophthalmic
------------------------------------------------------------------------
10-71......................... Ophthalmic optics-- ISO 14729 First
Contact lens care edition 2001-04-
products--Microbiolog 15 AMENDMENT 1
ical requirements and 2010-10-01.
test methods for
products and regimens
for hygienic
management of contact
lenses.
10-72......................... Ophthalmic ISO 15004-1
instruments--Fundamen First edition
tal requirements and 200-606-01.
test methods--Part 1:
General requirements
applicable to all
ophthalmic
instruments.
------------------------------------------------------------------------
J. Orthopedic
------------------------------------------------------------------------
11-232........................ Implants for surgery-- ISO 7207-1 Third
Components for edition 2007-02-
partial and total 01.
knee joint
prostheses--Part 1:
Classification,
definitions and
designation of
dimensions.
11-233........................ Standard ASTM F384--06
Specifications and (Reapproved
Test Methods for 2011).
Metallic Angled
Orthopedic Fracture
Fixation Devices.
11-234........................ Standard Test Method ASTM F732--00
for Wear Testing of (Reapproved
Polymeric Materials 2011).
Used in Total Joint
Prostheses.
------------------------------------------------------------------------
K. Radiology
------------------------------------------------------------------------
12-233........................ Lasers and laser- ISO 11670 Second
related equipment-- edition 2003-04-
Test methods for 01.
laser beam
parameters--Beam
positional stability.
12-239........................ SAFETY OF LASER IEC 60825-1
PRODUCTS--Part 1: (Second
Equipment edition--2007)
classification and I-SH 01
requirements, December 2009.
INTERPRETATION SHEET
1.
12-240........................ SAFETY OF LASER IEC 60825-1
PRODUCTS--Part 1: (2007), second
Equipment edition/I-SH 02
classification and January 2011.
requirements,
INTERPRETATION SHEET
2.
12-241........................ Medical electrical IEC 62274 First
equipment--Safety of edition 2005-
radiotherapy record 05.
and verify systems.
12-242........................ Medical electrical IEC 60601-2-57
equipment--Part 2-57: Edition 1.0
Particular 2011-01.
requirements for the
basic safety and
essential performance
of non-laser light
source equipment
intended for
therapeutic,
diagnostic,
monitoring and
cosmetic/aesthetic
use.
12-243........................ Optics and optical ISO 13694, First
instruments--Lasers edition 2000-04-
and laser-related 01.
equipment--Test
methods for laser
beam power [energy]
density distribution.
12-244........................ Ultrasonics--Field IEC 62359
characterization--Tes (Second
t methods for the edition--2010).
determination of
thermal and
mechanical indices
related to medical
diagnostic ultrasonic
fields CORRIGENDUM 1.
------------------------------------------------------------------------
[[Page 15778]]
L. Sterility
------------------------------------------------------------------------
14-325........................ Sterilization of ISO/TS 11139
health care products-- Second edition
Vocabulary. 2006-01-15.
14-326........................ Sterilization of ISO 11737-1
medical devices-- Second edition
Microbiological 2006-04-01.
methods--Part 1:
Determination of a
population of
microorganisms on
products.
14-327........................ Sterilization of ISO 11737-2
medical devices-- Second edition
Microbiological 2009-11-15.
methods--Part 2:
Tests of sterility
performed in the
definition,
validation and
maintenance of a
sterilization process.
14-328........................ Sterilization of ISO 11137-1
health care products-- First edition
Radiation--Part 1: 2006-04-15.
Requirements for
development,
validation and
routine control of a
sterilization process
for medical devices.
14-329........................ Sterilization of ISO 11137-2
health care products-- First edition
Radiation--Part 2: 2006-04-15.
Establishing the
sterilization dose.
14-330........................ Sterilization of ISO 11137-3
health careproducts-- First edition
Radiation--Part 3: 2006-04-15.
Guidance on
dosimetric aspects.
14-331........................ Sterilization of ISO 11135-1
health care products-- First edition
Ethylene oxide--Part 2007-05-01.
1: Requirements for
development,
validation and
routine control of a
sterilization process
for medical devices.
14-332........................ Sterilization of ISO 11140-5
health care products-- Second edition
Chemical indicators-- 2007-03-15.
Part 5: Class 2
indicators for Bowie
and Dick-type air
removal tests.
14-333........................ Sterilization of ISO 17665-1
health care products-- First edition
Moist heat--Part 1: 2006-08-15.
Requirements for the
development,
validation and
routine control of a
sterilization process
for medical devices.
14-334........................ Sterilization of ISO 15882 Second
health care products-- edition 2008-09-
Chemical indicators-- 01.
Guidance for
selection, use and
interpretation of
results.
14-335........................ Biological evaluation ISO 10993-7
of medical devices-- Second edition
Part 7: Ethylene 2008-10-15.
oxide sterilization
residuals.
14-336........................ Sterilization of ISO 14161 Second
health care products-- edition 2009-09-
Biological 15.
indicators--Guidance
for the selection,
use and
interpretation of
results.
14-337........................ Sterilization of ISO 14937 Second
health care products-- edition 2009-10-
General requirements 15.
for characterization
of a sterilizing
agent and the
development,
validation and
routine control of a
sterilization process
for medical devices.
14-338........................ Sterilization of ISO 11138-1
health care products-- Second edition
Biological 2006-07-01.
indicators--Part 1:
General requirements.
14-339........................ Sterilization of ANSI/AAMI/ISO
health care products-- 20857:2010.
Dry heat--
Requirements for the
development,
validation and
routine control of a
sterilization process
for medical devices.
14-340........................ Sterilization of ISO 20857 First
health care products-- edition 2010-08-
Dry heat-- 15.
Requirements for the
development,
validation and
routine control of a
sterilization process
for medical devices.
14-341........................ Standard Guide for ASTM E2303--11.
Absorbed-Dose Mapping
in Radiation
Processing Facilities.
14-342........................ Standard Practice for ASTM E2628--09
Dosimetry in \1\.
Radiation Processing.
14-343........................ Standard Guide for ASTM E2701--09.
Performance
Characterization of
Dosimeters and
Dosimetry Systems for
Use in Radiation
Processing.
14-344........................ Standard Practice for ASTM F2825--10
Climatic Stressing of \1\.
Packaging Systems for
Single Parcel
Delivery.
14-345........................ Standard guide for ISO/ASTM 51261
selection and First edition
calibration of 2002-03-15.
dosimetry systems for
radiation processing.
14-346........................ Standard Practice for ISO/ASTM 51276
Use of a Second edition
Polymethylmethacrylat 2002-12-15.
e Dosimetry System.
14-347........................ Standard Practice for ISO/ASTM 51702
Dosimetry in Gamma Second edition
Irradiation 2004-08-15.
Facilities for
Radiation Processing.
14-348........................ Aseptic processing of ANSI/AAMI/ISO
health care products-- 13408-2:2003.
Part 2: Filtration.
14-349........................ Aseptic processing of ANSI/AAMI/ISO
health care products-- 13408-3:2006.
Part 3:
Lyophilization.
14-350........................ Aseptic processing of ANSI/AAMI/ISO
health care products-- 13408-4:2005.
Part 4: Clean-in-
place technologies.
14-351........................ Aseptic processing of ANSI/AAMI/ISO
health care products-- 13408-5:2006.
Part 5: Sterilization
in place.
14-352........................ Aseptic processing of ANSI/AAMI/ISO
health care products-- 13408-6:2005.
Part 6: Isolator
systems.
14-353........................ Sterilization of ISO 11140-1
health care products-- Second edition
Chemical indicators-- 2005-07-15.
Part 1: General
requirements.
14-354........................ Sterilization of ISO 18472 First
health care products-- edition 2006-06-
Biological and 01.
chemical indicators--
Test equipment.
14-355........................ Packaging for ISO 11607-1
terminally sterilized First edition
medical devices--Part 2006-04-15.
1: Requirements for
materials, sterile
barrier systems and
packaging systems.
14-356........................ Packaging for ISO 11607-2
terminally sterilized First edition
medical devices--Part 2006-04-15.
2: Validation
requirements for
forming, sealing and
assembly processes.
14-357........................ Sterilization of ISO 11737-1:2006
medical devices-- TECHNICAL
Microbiological CORRIGENDUM 1
methods--Part 1: Published 2007-
Determination of a 05-15.
population of
microorganisms on
products.
------------------------------------------------------------------------
[[Page 15779]]
M. Tissue Engineering
------------------------------------------------------------------------
15-32......................... Standard Test Method ASTM F2260-03
for Determining (Reapproved
Degree of 2008).
Deacetylation in
Chitosan Salts by
Proton Nuclear
Magnetic Resonance
(\1\ H NMR)
Spectroscopy.
15-33......................... Standard Test Method ASTM F2602-08
for Determining the \1\.
Molar Mass of
Chitosan and Chitosan
Salts by Size
Exclusion
Chromatography with
Multi-angle Light
Scattering Detection
(SEC-MALS).
15-34......................... Standard Test Method ASTM F2605-08
for Determining the \1\.
Molar Mass of Sodium
Alginate by Size
Exclusion
Chromatography with
Multi-angle Light
Scattering Detection
(SEC-MALS).
15-35......................... Standard Guide for ASTM F2900-11.
Characterization of
Hydrogels used in
Regenerative Medicine.
15-36......................... Standard Guide for ASTM F2383-11.
Assessment of
Adventitious Agents
in Tissue Engineered
Medical Products
(TEMPs).
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the FD&C Act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be
properly considered, such recommendations should contain, at a minimum,
the following information: (1) Title of the standard; (2) any reference
number and date; (3) name and address of the national or international
standards development organization; (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply; and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards-related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 028'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. FDA will consider any comments received
in determining whether to amend the current listing of modifications to
the list of recognized standards, Recognition List Number: 028. These
modifications to the list or recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6389 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P