[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19196-19205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07467]
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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: 041
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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: 041'' (Recognition List Number: 041), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit electronic or written comments concerning this document
at any time. These modifications to the list of recognized standards
are effective April 4, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your
[[Page 19197]]
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 041.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. 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: 041.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 041 is available on
the Internet 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: 041 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 041'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
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 standards recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
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: 041
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions 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: 041'' to identify these current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(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
[[Page 19198]]
revisions to the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-92............................. 1-106 ISO 17510 First Edition 2015-08- Withdrawn and replaced with
01 Medical Devices--Sleep newer version.
Apnoea Breathing Therapy--Masks
and Application Accessories.
1-93............................. .............. ISO 5361 Second Edition 2012-10- Extent of recognition.
01 Anaesthetic and Respiratory
Equipment--Tracheal Tubes and
Connectors.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-180............................ .............. ANSI/AAMI/ISO 10993-16:2010/(R) Reaffirmation.
2014 Biological evaluation of
medical devices--Part 16:
Toxicokinetic study design for
degradation products and
leachables.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-119............................ .............. ISO 5841-3 Third Edition 2013-04- Withdrawn--Duplicate
15 Implants for surgery-- recognition--See 3-125.
Cardiac pacemakers--Part 3: Low-
profile connectors [is-i] for
implantable pacemakers.
3-138............................ .............. ASTM F2942-13 Standard Guide For Extent of recognition.
the In Vitro Axial, Bending,
and Rotational Durability Test
of Vascular Stents.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-121............................ 4-221 ISO 7494-2 Second Edition 2015- Withdrawn and replaced with
04-01 Dentistry--Dental units-- newer version.
Part 2: Air, water, suction and
wastewater system.
4-132............................ 4-222 ISO 6874 Third Edition 2015-09- Withdrawn and replaced with
01 Dentistry--Polymer-based pit newer version.
and fissure sealants.
4-178............................ 4-223 ISO 6872 Fourth Edition 2015-06- Withdrawn and replaced with
01 Dentistry--Ceramic materials. newer version.
4-190............................ .............. ANSI/ASA S3.35-2010 (R2015) Reaffirmation.
Method of Measurement of
Performance Characteristics of
Hearing Aids Under Simulated
Real-Ear Working Conditions.
4-194............................ .............. ANSI/ADA Specification No. 78: Extent of recognition.
2006, Dental Obturating Cones
(Modified adoption of ISO 6877-
1:1995, Dental Obturating
Points).
4-202............................ .............. ANSI/ADA Specification No. 58 Extent of recognition.
Root Canal Files, Type H
(Hedstrom).
4-209............................ 4-224 ISO 24234 Second Edition 2015-05- Withdrawn and replaced with
01 Dentistry--Dental amalgam. newer version.
4-210............................ 4-225 ISO 4823 Fourth Edition 2015-08- Withdrawn and replaced with
01 Dentistry--Elastomeric newer version.
impression materials.
4-213............................ .............. ISO 7494-1 Second Edition 2011- Extent of recognition.
08-15 Dentistry--Dental units--
Part 1: General requirements
and test methods.
4-214............................ .............. ISO 10139-1 Second Edition 2005- Extent of recognition.
02-15 Dentistry--Soft lining
materials for removable
dentures--Part 1: Materials for
short-term use [Including:
Technical Corrigendum 1 (2006)].
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-43............................. 5-98 ANSI/ESD S20.20-2014 Protection Withdrawn and replaced with
of Electrical and Electronic newer version.
Parts, Assemblies, and
Equipment (Excluding
Electrically Initiated
Explosive Devices).
5-80............................. 5-99 ASTM D4332-14 Standard Practice Withdrawn and replaced with
for Conditioning Containers, newer version.
Packages, or Packaging
Components for Testing.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility)(ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-7............................. 19-16 ANSI/AAMI HA60601-1-11:2015 (IEC Withdrawn and replaced with
60601-1-11:2015, MOD) MEDICAL newer version.
ELECTRICAL 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.
19-7............................. .............. AAMI/ANSI HA60601-1-11:2011, Transition period.
Medical electrical equipment--
Part 1-11: General requirements
for basic safety and essential
performance--Collateral
standard: Requirements for
medical electrical equipment
and medical electrical
equipment and medical
electrical systems used in the
home healthcare environment
(IEC 60601-1-11:2010 MOD).
----------------------------------------------------------------------------------------------------------------
[[Page 19199]]
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-169............................ 6-355 ASTM D3772--15 Standard Withdrawn and replaced with
Specification for Industrial newer version.
Rubber Finger Cots.
6-243............................ 6-356 ASTM D5712--15 Standard Test Withdrawn and replaced with
Method for Analysis of Aqueous newer version.
Extractable Protein in Latex,
Natural Rubber, and Elastomeric
Products Using the Modified
Lowry Method.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-167............................ 7-259 CLSI GP23-A Nongynecologic Withdrawn and replaced with
Cytologic Specimens: Collection newer version.
And Cytopreparatory Techniques;
Approved Guideline.
7-132............................ 7-260 CLSI MM03-A2 Molecular Withdrawn and replaced with
Diagnostic Methods for newer version.
Infectious Diseases; Approved
Guideline.
7-229............................ .............. CLSI M02-A11 Performance Withdrawn. See 7-258.
Standards for Antimicrobial
Disk Susceptibility Tests;
Approved Standard--Eleventh
Edition.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-103............................ .............. ASTM F1807-97 (Reapproved 2014) Reaffirmation.
Standard Practice for Corrosion
Fatigue Testing of Metallic
Implant Materials.
8-107............................ .............. ASTM F746-04 (Reapproved 2014) Reaffirmation.
Standard Test Method for
Pitting or Crevice Corrosion of
Metallic Surgical Implant
Materials.
8-114............................ .............. ASTM F2255-05 (Reapproved 2015) Reaffirmation.
Standard Test Method for
Strength Properties of Tissue
Adhesives in Lap-Shear by
Tension Loading.
8-115............................ .............. ASTM F2256-05 (Reapproved 2015) Reaffirmation.
Standard Test Method for
Strength Properties of Tissue
Adhesives in T-Peel by Tension
Loading.
8-116............................ .............. ASTM F2258-05 (Reapproved 2015) Reaffirmation.
Standard Test Method for
Strength Properties of Tissue
Adhesives in Tension.
8-121............................ .............. ASTM F2005-05 (Reapproved 2015) Reaffirmation.
Standard Terminology for Nickel-
Titanium Shape Memory Alloys.
8-134............................ 8-392 ASTM F2082-15 Standard Test Withdrawn and replaced with
Method for Determination of newer version.
Transformation Temperature of
Nickel-Titanium Shape Memory
Alloys by Bend and Free
Recovery.
8-135............................ .............. ASTM F2392-04 (Reapproved 2015) Reaffirmation.
Standard Test Method for Burst
Strength of Surgical Sealants.
8-136............................ .............. ASTM F2458-05 (Reapproved 2015) Reaffirmation.
Standard Test Method for Wound
Closure Strength of Tissue
Adhesives and Sealants.
8-167............................ 8-393 ASTM F1350-15 Standard Withdrawn and replaced with
Specification for Wrought newer version.
18Chromium-14Nickel-
2.5Molybdenum Stainless Steel
Surgical Fixation Wire (UNS
S31673).
8-168............................ 8-394 ASTM F1472-14 Standard Withdrawn and replaced with
Specification for Wrought newer version.
Titanium-6Aluminum-4Vanadium
Alloy for Surgical Implant
Applications (UNS R56400).
8-170............................ 8-395 ASTM F961-14 Standard Withdrawn and replaced with
Specification for 35Cobalt- newer version.
35Nickel-20Chromium-
10Molybdenum Alloy Forgings for
Surgical Implants (UNS R30035).
8-177............................ 8-396 ASTM F2129-15 Standard Test Withdrawn and replaced with
Method for Conducting Cyclic newer version.
Potentiodynamic Polarization
Measurements to Determine the
Corrosion Susceptibility of
Small Implant Devices.
8-179............................ .............. ASTM F754-08 (Reapproved 2015) Reaffirmation.
Standard Specification for
Implantable
Polytetrafluoroethylene (PTFE)
Sheet, Tube, and Rod Shapes
Fabricated from Granular
Molding Powders.
8-184............................ 8-397 ASTM F2516-14 Standard Test Withdrawn and replaced with
Method for Tension Testing of newer version.
Nickel-Titanium Superelastic
Materials.
8-189............................ 8-398 ASTM F1108-14 Standard Withdrawn and replaced with
Specification for Titanium- newer version.
6Aluminum-4Vanadium Alloy
Castings for Surgical Implants
(UNS R56406).
8-190............................ 8-399 ASTM F90-14 Standard Withdrawn and replaced with
Specification for Wrought newer version.
Cobalt-20Chromium-15Tungsten-
10Nickel Alloy for Surgical
Implant Applications (UNS
R30605).
8-192............................ 8-400 ASTM F1854-15 Standard Test Withdrawn and replaced with
Method for Stereological newer version.
Evaluation of Porous Coatings
on Medical Implants.
8-200............................ .............. ASTM F2003-02 (Reapproved 2015) Reaffirmation.
Standard Practice for
Accelerated Aging of Ultra-High
Molecular Weight Polyethylene
after Gamma Irradiation in Air.
8-204............................ 8-401 ASTM F2118-14 Standard Test Withdrawn and replaced with
Method for Constant Amplitude newer version.
of Force Controlled Fatigue
Testing of Acrylic Bone Cement
Materials.
[[Page 19200]]
8-206............................ 8-402 ASTM F688-14 Standard Withdrawn and replaced with
Specification for Wrought newer version.
Cobalt-35Nickel-20Chromium
10Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035).
8-225............................ .............. ASTM F2003-02 (Reapproved 2015) Withdrawn. See 8-200.
Standard Practice for
Accelerated Aging of Ultra-High
Molecular Weight Polyethylene
after Gamma Irradiation in Air.
8-363............................ 8-403 ASTM D638-14 Standard Test Withdrawn and replaced with
Method for Tensile Properties newer version.
of Plastics.
8-367............................ 8-404 ASTM E647-15 Standard Test Withdrawn and replaced with
Method for Measurement of newer version.
Fatigue Crack Growth Rates.
8-369............................ .............. ASTM F2003-02 (Reapproved 2015) Withdrawn. See 8-200.
Standard Practice for
Accelerated Aging of Ultra-High
Molecular Weight Polyethylene
after Gamma Irradiation in Air.
8-386............................ 8-405 ISO 5832-4 Third Edition 2014-09- Withdrawn and replaced with
15 Implants for surgery-- newer version.
Metallic materials--Part 4:
Cobalt-chromium-molybdenum
casting alloy.
8-387............................ 8-406 ISO 5832-11 Second Edition 2014- Withdrawn and replaced with
09-15 Implants for surgery-- newer version.
Metallic materials--Part 11:
Wrought titanium 6-aluminium 7-
niobium alloy.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-1............................. .............. ASTM E2490-09 (Reapproved 2015) Reaffirmation.
Standard Guide for Measurement
of Particle Size Distribution
of Nanomaterials in Suspension
by Photon Correlation
Spectroscopy (PCS).
----------------------------------------------------------------------------------------------------------------
K. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-61............................. .............. IEC 60601-2-18 Edition 3.0 2009- Withdrawn. Merged with 4-
08 Medical Electrical 187.
Equipment--Part 2-18:
Particular requirements for the
basic safety and essential
performance of endoscopic
equipment.
9-83............................. 9-110 ISO 8600-1 Fourth Edition 2015- Withdrawn and replaced with
10-15 Endoscopes--Medical newer version.
endoscopes and endotherapy
devices--Part 1: General
requirements.
9-96............................. .............. CEN EN 1618:1997 Catheters Other Duplicate recognition
Than Intravascular Catheters-- number. See 9-113.
Test Methods for Common
Properties.
9-102............................ 9-111 ISO 4074 Third Edition 2015-10- Withdrawn and replaced with
15 Natural rubber latex male newer version.
condoms--Requirements and test
methods.
9-109............................ 9-112 ASTM D3492-15 Standard Withdrawn and replaced with
Specification for Rubber newer version.
Contraceptives (Male Condoms).
----------------------------------------------------------------------------------------------------------------
L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-73............................ .............. ANSI Z80.21-2010 (R2015) Reaffirmation.
Ophthalmics--Instruments--Gener
al-Purpose Clinical Visual
Acuity Charts.
----------------------------------------------------------------------------------------------------------------
M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-207........................... 11-296 ASTM F2193-14 Standard Withdrawn and replaced with
Specifications and Test Methods newer version.
for Components Used in the
Surgical Fixation of the Spinal
Skeletal System.
11-214........................... 11-297 ASTM F382--14 Standard Withdrawn and replaced with
Specification and Test Method newer version.
for Metallic Bone Plates.
11-216........................... 11-298 ASTM F1264--14 Standard Withdrawn and replaced with
Specification and Test Methods newer version.
for Intramedullary Fixation
Devices.
11-220........................... 11-299 ASTM F2068--15 Standard Withdrawn and replaced with
Specification for Femoral newer version.
Prostheses--Metallic Implants.
11-227........................... .............. ASTM F366-10 (Reapproved 2015) Reaffirmation.
Standard Specification for
Fixation Pins and Wires.
11-228........................... .............. ASTM F564-10 (Reapproved 2015) Reaffirmation.
Standard Specification and Test
Methods for Metallic Bone
Staples.
11-247........................... .............. ASTM F2789-10 (Reapproved 2015) Reaffirmation.
Standard Guide for Mechanical
and Functional Characterization
of Nucleus Devices.
11-256........................... .............. ISO 14243-3 First Edition 2004- Withdrawn. See 11-292.
09-25 Implants for surgery--
Wear of total knee-joint
prostheses--Part 3: Loading and
displacement parameters for
wear-testing machines with
displacement control and
corresponding environmental
conditions for test [Including:
Technical Corrigendum 1(2006)].
11-262........................... 11-301 ASTM F2091-15 Standard Withdrawn and replaced with
Specification for Acetabular newer version.
Prostheses.
[[Page 19201]]
11-278........................... 11-302 ASTM F1717-15 Standard Test Withdrawn and replaced with
Methods for Spinal Implant newer version.
Constructs in a Vertebrectomy
Model.
----------------------------------------------------------------------------------------------------------------
N. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-158........................... 16-195 ISO 7176-1 Third Edition 2014-10- Withdrawn and replaced with
01 Wheelchairs--Part 1: newer version.
Determination of static
stability.
----------------------------------------------------------------------------------------------------------------
O. Radiology
----------------------------------------------------------------------------------------------------------------
12-139........................... .............. NEMA UD 2-2004 (R2009) Acoustic Reaffirmation.
output measurement standard for
diagnostic ultrasound
equipment, Revision 3.
12-187........................... .............. NEMA MS 3-2008 (R2014) Reaffirmation.
Determination of Image
Uniformity in Diagnostic
Magnetic Resonance Images.
12-188........................... .............. NEMA MS 1-2008 (R2014) Reaffirmation.
Determination of Signal-to-
Noise Ratio (SNR) in Diagnostic
Magnetic Resonance Imaging.
12-195........................... .............. NEMA MS 6-2008 (R2014) Reaffirmation.
Determination of Signal-to-
Noise Ratio and Image
Uniformity for Single-Channel,
Non-Volume Coils in Diagnostic
Magnetic Resonance Imaging
(MRI).
12-196........................... .............. NEMA MS 2-2008 (R2014) Reaffirmation.
Determination of Two-
Dimensional Geometric
Distortion in Diagnostic
Magnetic Resonance Images.
12-207........................... .............. IEC 60601-2-33 Ed. 3.0 2010 Extent of recognition.
Medical electrical equipment--
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for medical
diagnosis.
12-209........................... 12-293 IEC 60601-2-37 Ed. 2.1 b:2015 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Part 2-37: Particular
requirements for the basic
safety and essential
performance of ultrasonic
medical diagnostic and
monitoring equipment.
12-236........................... 12-294 IEC 60601-2-45 Ed. 3.1 b:2015 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Part 2-45: Particular
requirements for basic safety
and essential performance of
mammographic X-ray equipment
and mammographic stereotactic
devices.
12-257........................... 12-297 ISO 2919 Third Edition 2012-02- Duplicate recognition
15 Radiation protection--Sealed number. See 12-297.
radioactive sources--General
requirements and classification.
12-271........................... 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for medical
diagnosis.
12-274........................... 12-296 IEC 60601-2-54 Ed. 1.1 b:2015 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Part 2-54: Particular
requirements for the basic
safety and essential
performance of X-ray equipment
for radiography and radioscopy.
12-288........................... .............. NEMA MS 9-2008 (R2014) Reaffirmation.
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images (MRI).
----------------------------------------------------------------------------------------------------------------
P. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8............................. 13-79 IEC 62304 Edition 1.1 2015-06 Withdrawn and replaced with
Medical device software-- newer version.
Software life cycle processes.
13-50............................ 13-80 IEEE Std. 11073-20601: 2014 Withdrawn and replaced with
Health informatics--Personal newer version.
health device communication--
Part 20601: Application
profile--Optimized Exchange
Protocol [including:
Corrigendum 1 (2015)].
13-51............................ .............. IEEE Std. 11073-20601a-2010 Withdrawn. See 13-80.
Health informatics--Personal
health device communication--
Part 20601: Application
profile--Optimized Exchange
Protocol Amendment 1.
----------------------------------------------------------------------------------------------------------------
Q. Sterility
----------------------------------------------------------------------------------------------------------------
14-227........................... .............. ANSI/AAMI/ISO 11737-1:2006 Extent of recognition.
(R)2011 Sterilization of health
care products--Microbiological
methods--Part 1: Determination
of the population of
microorganisms on product.
14-261........................... .............. ANSI/AAMI/ISO 17665-1:2006/ Extent of recognition.
(R)2013 Sterilization of health
care products--Moist heat--Part
1: Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-277........................... .............. ISO/TS 17665-2 First Edition Extent of recognition.
2009-01-15 Sterilization of
health care products--Moist
heat--Part 2: Guidance on the
application of ISO 17665-1.
14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Extent of recognition.
(R)2014 Sterilization of
medical devices--
Microbiological methods--Part
2: Tests of sterility performed
in the definition, validation,
and maintenance of a
sterilization process.
[[Page 19202]]
14-291........................... .............. ANSI/AAMI/ISO 14937:2009/(R)2013 Extent of recognition.
Sterilization of healthcare
products--General requirements
for characterization of a
sterilizing agent and the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-296........................... .............. ANSI/AAMI/ISO 11138-1:2006/ Extent of recognition.
(R)2010 Sterilization of health
care products--Biological
indicators--Part 1: General
requirements.
14-298........................... .............. ANSI/AAMI/ISO 11137-3:2006/ Extent of recognition.
(R)2010 Sterilization of health
care products--Radiation--Part
3: Guidance on dosimetric
aspects.
14-327........................... .............. ISO 11737-2 Second Edition 2009- Extent of recognition.
11-15 Sterilization of medical
devices--Microbiological
methods--Part 2: Tests of
sterility performed in the
definition, validation, and
maintenance of a sterilization
process.
14-330........................... .............. ISO 11137-3 First Edition 2006- Extent of recognition.
04-15 Sterilization of health
care products--Radiation--Part
3: Guidance on dosimetric
aspects.
14-333........................... .............. ISO 17665-1 First Edition 2006- Extent of recognition.
08-15 Sterilization of health
care products--Moist heat--Part
1: Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-337........................... .............. ISO 14937 Second Edition 2009-10- Extent of recognition.
15 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.
14-338........................... .............. ISO 11138-1 Second Edition 2006- Extent of recognition.
07-01 Sterilization of health
care products--Biological
indicators--Part 1: General
requirements.
14-339........................... .............. ANSI/AAMI/ISO 20857:2010 Extent of recognition.
Sterilization of health care
products--Dry heat--
Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-340........................... .............. ISO 20857 First Edition 2010-08- Extent of recognition.
15 Sterilization of health care
products--Dry heat--
Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Reaffirmation.
(R)2015 Aseptic processing of
health care products--Part 3:
Lyophilization.
14-351........................... .............. ANSI/AAMI/ISO 13408-5:2006/ Reaffirmation.
(R)2015 Aseptic processing of
health care products--Part 5:
Sterilization in place.
14-376........................... .............. ANSI/AAMI/ISO TIR17665-2:2009 Extent of recognition.
Sterilization of health care
products--Moist heat--Part 2:
Guidance on the application of
ANSI/AAMI/ISO 17665-1.
14-407........................... .............. ISO 11737-1 Second Edition 2006- Extent of recognition.
04-01 Sterilization of medical
devices--Microbiological
methods--Part 1: Determination
of a population of
microorganisms on products
[Including: Technical
Corrigendum 1 (2007)].
14-409........................... .............. ISO 11137-2 Third Edition 2013- Extent of recognition.
06-01 Sterilization of health
care products--Radiation--Part
2: Establishing the
sterilization dose.
14-428........................... .............. ISO 11137-1 First Edition 2006- Extent of recognition.
04-15 Sterilization of health
care products--Radiation--Part
1: Requirements for
development, validation, and
routine control of a
sterilization process for
medical devices [Including:
Amendment 1 (2013)].
14-438........................... .............. ANSI/AAMI/ISO 11137-2:2013 Extent of recognition.
Sterilization of health care
products--Radiation--Part 2:
Establishing the sterilization
dose.
14-452........................... .............. ISO 11135 Second Edition 2014, Extent of recognition.
Sterilization of health care
products--Ethylene oxide--
Requirements for development,
validation, and routine control
of a sterilization process for
medical devices.
14-461........................... .............. ANSI/AAMI/ISO 11137-1:2006/(R) Extent of recognition.
2010 Sterilization of health
care products--Radiation--Part
1: Requirements for
development, validation, and
routine control of a
sterilization process for
medical devices [Including:
Amendment 1 (2013)].
----------------------------------------------------------------------------------------------------------------
R. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-8............................. 15-42 ASTM F2064-14 Standard Guide for Withdrawn and replaced with
Characterization and Testing of newer version.
Alginates as Starting Materials
Intended for Use in Biomedical
and Tissue Engineered Medical
Product Applications.
15-22............................ 15-43 ASTM F2791-15 Standard Guide for Withdrawn and replaced with
Assessment of Surface Texture newer version.
of Non-Porous Biomaterials in
Two Dimensions.
15-24............................ .............. ASTM F2721-09 (Reapproved 2014) Reaffirmation.
Standard Guide for Pre-clinical
in vivo Evaluation in Critical
Size Segmental Bone Defects.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
[[Page 19203]]
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 041.
Table 2--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-107............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5356-1:2004.
Equipment--Conical Connectors--
Part 1: Cones and Sockets.
1-108............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5361:2012.
Equipment--Tracheal Tubes and
Connectors.
1-109............................ Anaesthetic Reservoir Bags....... ANSI/AAMI/ISO 5362:2006.
1-110............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5366-1:2000.
Equipment--Tracheostomy Tubes--
Part 1: Tubes and Connectors for
Use in Adults.
1-111............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5366-3:2001.
Equipment--Tracheostomy Tubes--
Part 3: Paediatric Tracheostomy
Tubes.
1-112............................ Lung Ventilators--Part 4: ANSI/AAMI/ISO 10651-4:2002.
Particular Requirements for
Operator-Powered Resuscitators.
1-113............................ Lung Ventilators for Medical Use-- ANSI/AAMI/ISO 10651-5:2006.
Particular Requirements for
Basic Safety and Essential
Performance--Part 5: Gas-powered
Emergency Resuscitators.
1-114............................ Inhalational Anaesthesia Systems-- ISO 18835 First Edition 2015-04-01.
Draw-over Anaesthetic Systems.
1-115............................ Medical Electrical Equipment-- ISO 80601-2-70 First Edition 2015-01-15.
Part 2-70: Particular
Requirements for Basic Safety
and Essential Performance of
Sleep Apnoea Breathing Therapy
Equipment.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-223............................ Standard Guide for Selecting ASTM F2901-13.
Tests to Evaluate Potential
Neurotoxicity of Medical Devices.
2-225............................ Standard Practice for Testing for ASTM F2567-06 (Reapproved 2010).
Classical Complement Activation
in Serum By Solid Materials.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-140............................ Cardiovascular implants--Cardiac ANSI/AAMI/ISO 5840-3: 2013.
valve prostheses--Part 3: Heart
valve substitutes implanted by
transcatheter techniques.
3-141............................ Implants for surgery--Cardiac ANSI/AAMI/ISO 5841-3: 2013.
pacemakers--Part 3: Low-profile
connectors (IS-1) for
implantable pacemakers.
----------------------------------------------------------------------------------------------------------------
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-226............................ Dentistry--Powered polymerization ISO 10650 First Edition 2015-09-01.
activators.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management)
----------------------------------------------------------------------------------------------------------------
5-100............................ Small-bore connectors for liquids ANSI/AAMI/ISO 80369-20:2015.
and gases in healthcare
applications--Part 20: Common
test methods.
5-101............................ Small-bore connectors for liquids AAMI/CN6:2015.
and gases in healthcare
applications--Part 6: Connectors
for neuraxial applications.
----------------------------------------------------------------------------------------------------------------
F. General II (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-17............................ American National Standard ANSI/IEEE C63.18-2014.
Recommended Practice for an On-
Site, Ad Hoc Test Method for
Estimating Electromagnetic
Immunity of Medical Devices to
Radiated Radio-Frequency (RF)
Emissions from RF Transmitters.
19-18............................ Safety requirements for IEC 61010-1 Edition 3.0 2010-06.
electrical equipment for
measurement, control, and
laboratory use--Part 1: General
requirements [Including:
Corrigendum 1 (2011)].
----------------------------------------------------------------------------------------------------------------
[[Page 19204]]
G. GH/GPS
----------------------------------------------------------------------------------------------------------------
6-357............................ Intravascular Catheters--Sterile ISO 10555-6 First Edition 2015-04-15.
and Single-use Catheters--Part
6: Subcutaneous Implanted Ports.
6-358............................ Infusion Equipment for Medical ISO 8536-8 Second Edition 2015-06-15.
Use--Part 8: Infusion Sets for
Single Use with Pressure
Infusion Apparatus.
6-359............................ Infusion Equipment for Medical ISO 8536-9 Second Edition 2015-06-15.
Use--Part 9: Fluid Lines for
Single Use with Pressure
Infusion Equipment.
6-360............................ Infusion Equipment for Medical ISO 8536-10 Second Edition 2015-06-15.
Use--Part 10: Accessories for
Fluid Lines for Single Use with
Pressure Infusion Equipment.
6-361............................ Infusion Equipment for Medical ISO 8536-11 Second Edition 2015-06-15.
Use--Part 11: Infusion Filters
for Single Use with Pressure
Infusion Equipment.
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
8-407............................ Standard Specification for ISO/ASTM 52915 First Edition 2013-06-01.
Additive Manufacturing File
Format (AMF) Version 1.1.
8-408............................ Standard Guide for Evaluating ASTM F3122-14.
Mechanical Properties of Metal
Materials Made via Additive
Manufacturing Processes.
8-409............................ Standard Specification for ASTM F2924-14.
Additive Manufacturing Titanium-
6 Aluminum-4 Vanadium with
Powder Bed Fusion.
8-410............................ Standard Guide for Assessment of ASTM F2902-12.
Absorbable Polymeric Implants.
8-411............................ Specification for Amorphous ASTM F2579-10.
Poly(lactide) and Poly(lactide-
co-glycolide) Resins for
Surgical Implants.
8-412............................ Standard Practice for Calibration ASTM F2537-06 (Reapproved 2011).
of Linear Displacement Sensor
Systems Used to Measure
Micromotion.
8-413............................ Standard Test Methods for ASTM F2819-10 (Reapproved 2015).
Measurement of Straightness of
Bar, Rod, Tubing, and Wire to be
used for Medical Devices.
8-414............................ Standard Practice for Reporting ASTM F2847-10.
and Assessment of Residues on
Single Use Implants.
8-415............................ Standard Test Method for ASTM F2778-09 (Reapproved 2015).
Measurement of Percent
Crystallinity of
Polyetheretherketone (PEEK)
Polymers by Means of Specular
Reflectance Fourier Transform
Infrared Spectroscopy (R-FTIR)..
8-416............................ Standard Test Method for Small ASTM F2977-13.
Punch Testing of Polymeric
Biomaterials Used in Surgical
Implants.
8-417............................ Test Method for Standard Test ASTM F3044-14.
Method for Evaluating the
Potential for Galvanic Corrosion
for Medical Implants.
8-418............................ Standard Test Methods for ASTM F640-12.
Determining Radiopacity for
Medical Use.
8-419............................ Standard Specification for Metal ASTM F2885-11.
Injection Molded Titanium-6
Aluminum-4 Vanadium Components
for Surgical Implant
Applications.
8-420............................ Standard Specification for Metal ASTM F2886-10.
Injection Molded Cobalt-28
Chromium-6 Molybdenum Components
for Surgical Implant
Applications.
----------------------------------------------------------------------------------------------------------------
I. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-100........................... Ophthalmic optics--Contact lens ISO 18259 First Edition 2014-10-01.
care products--Method to assess
contact lens care products with
contact lenses in a lens case,
challenged with bacterial and
fungal organisms.
----------------------------------------------------------------------------------------------------------------
J. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-303........................... Standard Guide for High Demand ASTM F3047M-15.
Hip Simulator Wear Testing of
Hard-on-hard Articulations.
[[Page 19205]]
11-304........................... Measuring Accuracy after ASTM F3107-14.
Mechanical Disturbances.
----------------------------------------------------------------------------------------------------------------
K. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-196........................... Wheelchairs--Part 7: Measurement ISO 7176-7 First Edition 1998-05-15.
of seating and wheel dimensions.
16-197........................... Wheelchairs--Part 8: Requirements ISO 7176-8 Second Edition 2014-12-15.
and test methods for static,
impact, and fatigue strengths.
16-198........................... Wheelchairs--Part 22: Set-up ISO 7176-22 Second Edition 2014-09-01.
procedures.
----------------------------------------------------------------------------------------------------------------
L. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-81............................ Health informatics--Personal IEEE Std. 11073-10419: 2015.
health device communication--
Part 10419: Device
Specialization--Insulin Pump.
----------------------------------------------------------------------------------------------------------------
M. Sterility
----------------------------------------------------------------------------------------------------------------
14-479........................... Sterilization of health care ANSI/AAMI/ISO 11135:2014.
products--Ethylene oxide--
Requirements for development,
validation, and routine control
of a sterilization process for
medical devices.
----------------------------------------------------------------------------------------------------------------
N. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-44............................ Standard Guide for in vivo ASTM F2529-13.
Evaluation of Osteoinductive
Potential for Materials
Containing Demineralized Bone
(DBM) Active Standard.
----------------------------------------------------------------------------------------------------------------
\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 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 revisions to the list of recognized consensus standards, as needed,
in the Federal Register, once a year or more often if necessary.
Beginning with Recognition List: 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
standards@cdrh.fda.gov. 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. The Center for Devices and
Radiological Health (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, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 041'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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.
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07467 Filed 4-1-16; 8:45 am]
BILLING CODE 4164-01-P