83 FR 53264 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range		53264-53271
FR Document		2018-22977

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: 050'' (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Federal Register, Volume 83 Issue 204 (Monday, October 22, 2018)

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53264-53271]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22977]

-----------------------------------------------------------------------

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: 050

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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: 050'' (Recognition List Number: 050), 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 October 22, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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: 050.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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: 050.
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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 050 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA recognized consensus standards, including Recognition List Number:
050 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: 050'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
CDRHStandardsStaff@fda.hhs.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

[[Page 53265]]

premarket review submissions or other requirements.
In the Federal Register notice of September 13, 2018 (83 FR 46738),
FDA announced the availability of a guidance entitled ``Appropriate use
of Voluntary Consensus Standards in Premarket Submission for Medical
Devices.'' The guidance describes how FDA has implemented its standard
recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized
standards, as published in the Federal Register, can be accessed at
https://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. Additional information
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 050

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 050'' to identify the 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 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 recognition Title of standard Change \2\
No. No. \1\
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-85.............. 1-139 ISO 80601-2-61 Withdrawn and
Second edition replaced with
2017-12 newer version.
(Corrected
version 2018-02)
Medical
electrical
equipment--Part
2-61: Particular
requirements for
basic safety and
essential
performance of
pulse oximeter
equipment.
1-96.............. 1-140 ISO 80601-2-55 Withdrawn and
Second edition replaced with
2018-02 Medical newer version.
electrical
equipment--Part
2-55: Particular
requirements for
the basic safety
and essential
performance of
respiratory gas
monitors.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-176............. 2-255 ISO 10993-11 Withdrawn and
Third edition replaced with
2017-09 newer version.
Biological
evaluation of
medical devices--
Part 11: Tests
for systemic
toxicity.
2-204............. 2-256 ASTM F720-17 Withdrawn and
Standard replaced with
Practice for newer version.
Testing Guinea
Pigs for Contact
Allergens:
Guinea Pig
Maximization
Test.
2-233............. 2-257 ASTM F2382-17e1 Withdrawn and
Standard Test replaced with
Method for newer version.
Assessment of
Circulating
Blood-Contacting
Medical Device
Materials on
Partial
Thromboplastin
Time (PTT).
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-110............. .............. AAMI TIR41:2011/ Reaffirmation.
(R)2017
Technical
Information
Report Active
implantable
medical devices--
Guidance for
designation of
left ventricle
and implantable
cardioverter
defibrillator
lead connectors
and pulse
generator
connector
cavities for
implantable
pacemakers and
implantable
cardioverter
defibrillators.
3-123............. 3-152 IEC 80601-2-30 Withdrawn and
Edition 1.1 2013- replaced with
07 Medical newer version.
electrical
equipment--Part
2-30: Particular
requirements for
the basic safety
and essential
performance of
automated non-
invasive
sphygmomanometer
s.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-214............. 4-242 ISO 10139-1 Third Withdrawn and
edition 2018-03 replaced with
Dentistry--Soft newer version.
lining materials
for removable
dentures--Part
1: Materials for
short-term use.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-42.............. .............. ASTM D903-98 Reaffirmation.
(Reapproved
2017) Standard
Test Method for
Peel or
Stripping
Strength of
Adhesive Bonds.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-8.............. .............. IEC 60601-1-2 Extent of
Edition 4.0 2014- recognition.
02 Medical
electrical
equipment--Part
1-2: General
requirements for
basic safety and
essential
performance--Col
lateral
Standard:
Electromagnetic
disturbances--Re
quirements and
tests.
19-19............. .............. IEC TR 60601-4-2 Extent of
Edition 1.0 2016- recognition.
05 Medical
electrical
equipment--Part
4-2: Guidance
and
interpretation--
Electromagnetic
immunity:
performance of
medical
electrical
equipment and
medical
electrical
systems.

[[Page 53266]]

19-21............. 19-30 AIM Standard Withdrawn and
7351731 Rev. replaced with
2.00 Medical newer version.
Electrical
Equipment and
System
Electromagnetic
Immunity Test
for Exposure to
Radio Frequency
Identification
Readers--An AIM
Standard.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-123............. .............. ASTM E667-98 Reaffirmation.
(Reapproved
2017) Standard
Specification
for
Mercury[hyphen]i
n[hyphen]Glass,
Maximum
Self[hyphen]Regi
stering Clinical
Thermometers.
6-254............. .............. ASTM F2100-11 Reaffirmation.
(Reapproved
2018) Standard
Specification
for Performance
of Materials
Used in Medical
Face Masks.
6-301............. 6-408 ISO 10555-1 Withdrawn and
Second edition replaced with
2013-06-15 newer version
Intravascular including
catheters--Steri amendment.
le and single-
use catheters--
Part 1: General
requirements
[Including
AMENDMENT 1
(2017)].
6-352............. 6-409 ASTM F703-18 Withdrawn and
Standard replaced with
Specification newer version.
for Implantable
Breast
Prostheses.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-127............. 7-275 CLSI EP07 3rd Withdrawn and
Edition replaced with
Interference newer version.
Testing in
Clinical
Chemistry.
7-171............. 7-276 CLSI M38 3rd Withdrawn and
Edition replaced with
Reference Method newer version.
for Broth
Dilution
Antifungal
Susceptibility
Testing of
Filamentous
Fungi.
7-201............. 7-277 CLSI GP41 7th Withdrawn and
Edition replaced with
Collection of newer version.
Diagnostic
Venous Blood
Specimens.
7-204............. 7-278 CLSI M27 4th Withdrawn and
Edition replaced with
Reference Method newer version.
for Broth
Dilution
Antifungal
Susceptibility
Testing of
Yeasts.
7-217............. .............. CLSI M60 1st Title change.
Edition
Performance
Standards for
Antifungal
Susceptibility
Testing of
Yeasts.
7-240............. .............. CLSI M27-S4 Withdrawn. See 7-
Reference Method 217.
for Broth
Dilution
Antifungal
Susceptibility
Testing of
Yeasts; Fourth
Informational
Supplement.
7-245............. .............. CLSI EP09-A3 Withdrawn.
Measurement
Procedure
Comparison and
Bias Estimation
Using Patient
Samples;
Approved
Guideline--Third
Edition.
7-254............. 7-279 CLSI M07 11th Withdrawn and
Edition Methods replaced with
for Dilution newer version.
Antimicrobial
Susceptibility
Tests for
Bacteria That
Grow Aerobically.
7-258............. 7-280 CLSI M02 13th Withdrawn and
Edition replaced with
Performance newer version.
Standards for
Antimicrobial
Disk
Susceptibility
Tests.
7-271............. 7-281 CLSI M100 28th Withdrawn and
Edition replaced with
Performance newer version.
Standards for
Antimicrobial
Susceptibility
Testing.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-57.............. 8-465 ISO 5832-2 Fourth Withdrawn and
edition 2018-03 replaced with
Implants for newer version.
surgery--Metalli
c materials--
Part 2:
Unalloyed
titanium.
8-112............. .............. ASTM F1044-05 Reaffirmation.
(Reapproved
2017)e1 Standard
Test Method for
Shear Testing of
Calcium
Phosphate
Coatings and
Metallic
Coatings.
8-128............. 8-466 ASTM F2213-17 Withdrawn and
Standard Test replaced with
Method for newer version.
Measurement of
Magnetically
Induced Torque
on Medical
Devices in the
Magnetic
Resonance
Environment.
8-330............. 8-467 ASTM F1978-18 Withdrawn and
Standard Test replaced with
Method for newer version.
Measuring
Abrasion
Resistance of
Metallic Thermal
Spray Coatings
by Using the
Taber Abraser.
8-334............. 8-468 ASTM F2459-18 Withdrawn and
Standard Test replaced with
Method for newer version.
Extracting
Residue from
Metallic Medical
Components and
Quantifying via
Gravimetric
Analysis.
8-372............. 8-469 ASTM F560-17 Withdrawn and
Standard replaced with
Specification newer version.
for Unalloyed
Tantalum for
Surgical Implant
Applications
(UNS R05200, UNS
R05400).
8-380............. .............. ASTM F1160-14 Reaffirmation.
(Reapproved
2017)e1 Standard
Test Method for
Shear and
Bending Fatigue
Testing of
Calcium
Phosphate and
Metallic Medical
and Composite
Calcium
Phosphate/
Metallic
Coatings.
8-382............. 8-470 ASTM F2102-17 Withdrawn and
Standard Guide replaced with
for Evaluating newer version.
the Extent of
Oxidation in
Polyethylene
Fabricated Forms
Intended for
Surgical
Implants.
8-390............. 8-471 ASTM F1925-17 Withdrawn and
Standard replaced with
Specification newer version.
for Semi-
Crystalline
Poly(lactide)
Polymer and
Copolymer Resins
for Surgical
Implants.
8-412............. .............. ASTM F2537-06 Reaffirmation.
(Reapproved
2017) Standard
Practice for
Calibration of
Linear
Displacement
Sensor Systems
Used to Measure
Micromotion.
8-414............. 8-472 ASTM F2847-17 Withdrawn and
Standard replaced with
Practice for newer version.
Reporting and
Assessment of
Residues on
Single-Use
Implants and
Single-Use
Sterile
Instruments.
8-419............. 8-473 ASTM F2885-17 Withdrawn and
Standard replaced with
Specification newer version.
for Metal Extent of
Injection Molded recognition.
Titanium-
6Aluminum-
4Vanadium
Components for
Surgical Implant
Applications.
8-420............. 8-474 ASTM F2886-17 Withdrawn and
Standard replaced with
Specification newer version.
for Metal
Injection Molded
Cobalt-
28Chromium-
6Molybdenum
Components for
Surgical Implant
Applications.

[[Page 53267]]

8-436............. 8-475 ASTM F2026-17 Withdrawn and
Standard replaced with
Specification newer version.
for
Polyetheretherke
tone (PEEK)
Polymers for
Surgical Implant
Applications.
8-448............. 8-476 ASTM F2004-17 Withdrawn and
Standard Test replaced with
Method for newer version.
Transformation
Temperature of
Nickel-Titanium
Alloys by
Thermal Analysis.
8-454............. 8-477 ASTM F2129-17b Withdrawn and
Standard Test replaced with
Method for newer version.
Conducting
Cyclic
Potentiodynamic
Polarization
Measurements to
Determine the
Corrosion
Susceptibility
of Small Implant
Devices.
------------------------------------------------------------------------
J. Nanotechnology
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-43.............. 9-117 ISO 16038 Second Withdrawn and
edition 2017-11 replaced with
Male condoms-- newer version.
Guidance on the
use of ISO 4074
and ISO 23409 in
the quality
management of
condoms.
9-67.............. .............. ASTM D7661-10 Reaffirmation.
(Reapproved
2017) Standard
Test Method for
Determining
Compatibility of
Personal
Lubricants with
Natural Rubber
Latex Condoms.
9-92.............. 9-118 ISO 8637-1 First Withdrawn and
edition 2017-11 replaced with
Extracorporeal newer version.
systems for
blood
purification--Pa
rt 1:
Haemodialysers,
haemodiafilters,
haemofilters and
haemoconcentrato
rs.
9-95.............. 9-119 IEC 60601-2-36 Withdrawn and
Edition 2.0 2014- replaced with
04 Medical new recognition
electrical number.
equipment--Part
2-36: Particular
requirements for
the safety of
equipment for
extracorporeally
induced
lithotripsy.
9-112............. 9-120 ASTM D3492-16 Withdrawn and
Standard replaced with
Specification newer version.
for Rubber
Contraceptives
(Male Condoms).
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-56............. .............. ANSI Z80.12-2007 Reaffirmation.
(R2017) American
National
Standard for
Ophthalmics--Mul
tifocal
Intraocular
Lenses.
10-57............. .............. ANSI Z80.13-2007 Reaffirmation.
(R2017) American
National
Standard for
Ophthalmics--Pha
kic Intraocular
Lenses.
10-60............. 10-111 ISO 11981 Third Withdrawn and
edition 2017-11 replaced with
Ophthalmic newer version.
optics--Contact
lenses and
contact lens
care products--
Determination of
physical
compatibility of
contact lens
care products
with contact
lenses.
10-67............. 10-112 ISO 11986 Third Withdrawn and
edition 2017-11 replaced with
Ophthalmic newer version.
optics--Contact
lenses and
contact lens
care products--
Determination of
preservative
uptake and
release.
10-84............. .............. ANSI Z80.11-2012 Reaffirmation.
(R2017) American
National
Standard for
Ophthalmics--Las
er Systems for
Corneal
Reshaping.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-185............ .............. ASTM F2267-04 Reaffirmation.
(Reapproved
2018) Standard
Test Method for
Measuring Load
Induced
Subsidence of
Intervertebral
Body Fusion
Device Under
Static Axial
Compression.
11-197............ .............. ASTM F983-86 Reaffirmation.
(Reapproved
2018) Standard
Practice for
Permanent
Marking of
Orthopaedic
Implant
Components.
11-199............ .............. ASTM F565-04 Reaffirmation.
(Reapproved
2018) Standard
Practice for
Care and
Handling of
Orthopedic
Implants and
Instruments.
11-203............ 11-322 ASTM F1541-17 Withdrawn and
Standard replaced with
Specification newer version.
and Test Methods
for External
Skeletal
Fixation Devices.
11-224............ 11-323 ASTM F2706-17 Withdrawn and
Standard Test replaced with
Methods for newer version.
Occipital-
Cervical and
Occipital-
Cervical-
Thoracic Spinal
Implant
Constructs in a
Vertebrectomy
Model.
11-226............ 8-478 ASTM F1089-18 Withdrawn and
Standard Test replaced with
Method for newer version.
Corrosion of Transferred.
Surgical
Instruments.
11-227............ 11-324 ASTM F366-17 Withdrawn and
Standard replaced with
Specification newer version.
for Fixation
Pins and Wires.
11-228............ 11-325 ASTM F564-17 Withdrawn and
Standard replaced with
Specification newer version.
and Test Methods
for Metallic
Bone Staples.
11-245............ 11-326 ASTM F384-17 Withdrawn and
Standard replaced with
Specifications newer version.
and Test Methods
for Metallic
Angled
Orthopedic
Fracture
Fixation Devices.
11-257............ 11-327 ASTM F543-17 Withdrawn and
Standard replaced with
Specification newer version.
and Test Methods
for Metallic
Medical Bone
Screws.
11-261............ 11-328 ASTM F1378-17 Withdrawn and
Standard replaced with
Specification newer version.
for Shoulder
Prostheses.

[[Page 53268]]

11-271............ 11-329 ASTM F2180-17 Withdrawn and
Standard replaced with
Specification newer version.
for Metallic
Implantable
Strands and
Cables.
11-284............ 11-330 ASTM F2028-17 Withdrawn and
Standard Test replaced with
Methods for newer version.
Dynamic
Evaluation of
Glenoid
Loosening or
Disassociation.
11-288............ 11-331 ASTM F2077-17 Withdrawn and
Test Methods for replaced with
Intervertebral newer version.
Body Fusion
Devices.
11-296............ 11-332 ASTM F2193-18 Withdrawn and
Standard replaced with
Specification newer version.
and Test Methods
for Components
Used in the
Surgical
Fixation of the
Spinal Skeletal
System.
11-297............ 11-333 ASTM F382-17 Withdrawn and
Standard replaced with
Specification newer version.
and Test Method
for Metallic
Bone Plates.
11-310............ .............. ASTM F1611-00 Reaffirmation.
(Reapproved
2018) Standard
Specification
for
Intramedullary
Reamers.
11-315............ 11-334 ASTM F1829-17 Withdrawn and
Standard Test replaced with
Method for newer version.
Static
Evaluation of
Anatomic Glenoid
Locking
Mechanism in
Shear.
11-318............ 11-335 ASTM F3141-17a Withdrawn and
Standard Guide replaced with
for Total Knee newer version.
Replacement
Loading Profiles.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-159............ 16-202 ISO 7176-2 Third Withdrawn and
edition 2017-10 replaced with
Wheelchairs--Par newer version.
t 2:
Determination of
dynamic
stability of
electric
wheelchairs.
16-185............ .............. ANSI RESNA WC- Extent of
2:2009 American recognition.
National
Standard for
Wheelchairs--Vol
ume 2,
Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical
Systems Section
21: Requirements
and test methods
for
electromagnetic
compatibility of
electrically
powered
wheelchairs and
motorized
scooters.
16-193............ 16-203 ASME A18.1-2017 Withdrawn and
Safety Standard replaced with
for Platform newer version.
Lifts and
Stairway
Chairlifts.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-202............ .............. IEC 60601-2-43 Recognition
Edition 2.0 2010- restored with
03 Medical transition
electrical period.
equipment--Part
2-43: Particular
requirements for
the safety and
essential
performance of X-
ray equipment
for
interventional
procedures.
12-204............ .............. IEC 60601-2-28 Recognition
Edition 2.0 2010- restored with
03 Medical transition
electrical period.
equipment--Part
2-28: Particular
requirements for
the basic safety
and essential
performance of X-
ray tube
assemblies for
medical
diagnosis.
12-296............ 12-317 IEC 60601-2-54 Withdrawn and
CONSOLIDATED replaced with
VERSION Edition newer version
1.1 2015-04 including
Medical amendment.
electrical
equipment--Part
2-54: Particular
requirements for
the basic safety
and essential
performance of X-
ray equipment
for radiography
and radioscopy
[Including:
Amendment 2
(2018)].
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-138............ 14-512 ISO 13408-2 Withdrawn and
Second edition replaced with
2018-01 Aseptic newer version.
processing of
health care
products--Part
2: Sterilizing
filtration.
14-275............ .............. ANSI/AAMI Reaffirmation.
ST41:2008/
(R)2018 Ethylene
oxide
sterilization in
health care
facilities:
Safety and
effectiveness.
14-293............ .............. ANSI/AAMI Reaffirmation.
ST50:2004/
(R)2018 Dry heat
(heated air)
sterilizers.
14-294............ .............. ANSI/AAMI Reaffirmation.
ST40:2004/
(R)2018 Table-
top dry heat
(heated air)
sterilization
and sterility
assurance in
health care
facilities.
14-295............ .............. ANSI/AAMI Withdrawn. See 14-
ST81:2004/ 515.
(R)2016
Sterilization of
medical devices--
Information to
be provided by
the manufacturer
for the
processing of
resterilizable
medical devices.
14-344............ 14-513 ASTM F2825-18 Withdrawn and
Standard replaced with
Practice for newer version.
Climatic
Stressing of
Packaging
Systems for
Single Parcel
Delivery.
14-407............ 14-514 ISO 11737-1 Third Withdrawn and
edition 2018-01 replaced with
Sterilization of newer version.
health care
products--Microb
iological
methods--Part 1:
Determination of
a population of
microorganisms
on products.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
\2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with
newer version'' will have a transition period with an expiration date
as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

[[Page 53269]]

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: 050.

Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-153................. Standard Guide for Coating ASTM F2743-11.
Inspection and Acute
Particulate
Characterization of
Coated Drug-Eluting
Vascular Stent Systems.
3-154................. Standard Guide for Fatigue- ASTM F3211-17.
to-Fracture (FtF)
Methodology for
Cardiovascular Medical
Devices.
3-155................. Medical electrical IEC 60601-2-47
equipment--Part 2-47: Edition 2.0 2012-
Particular requirements 02.
for the basic safety and
essential performance of
ambulatory
electrocardiographic
systems.
3-156................. Implants for surgery-- ISO 14708-1 Second
Active implantable edition 2014-08-15.
medical devices--Part 1:
General requirements for
safety, marking and for
information to be
provided by the
manufacturer.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-243................. Corrosion Test Methods.... ANSI/ADA Standard
No. 97:2002/ISO
10271:2001
Reaffirmed by ANSI:
May 29, 2013.
4-244................. Dentistry--Test methods ISO 8325 Second
for rotary instruments. edition 2004-09-15.
4-245................. Dentistry--Corrosion test ISO 10271 Second
methods for metallic edition 2011-08-01.
materials.
4-246................. Dentistry--Pre-capsulated ISO 20749 First
dental amalgam. edition 2017-03.
4-247................. Dentistry--Laser welding ISO 28319 Second
and filler materials. edition 2018-04.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-118................. Guidance for the creation AAMI TIR66:2017.
of physiologic data and
waveform databases to
demonstrate reasonable
assurance of the safety
and effectiveness of
alarm system algorithms.
5-119................. Medical devices-- ISO 18250-3 First
Connectors for reservoir edition 2018-06.
delivery systems for
healthcare applications--
Part 3: Enteral
application.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-31................. American National Standard ANSI C63.15-2017
Recommended Practice for (Revision of ANSI
the Immunity Measurement C63.15-2016).
of Electrical and
Electronic Equipment.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-282................. Performance Standards for CLSI M60 1st
Antifungal Susceptibility Edition.
Testing of Yeasts.
7-283................. Essential Tools for CLSI POCT04 3rd
Implementation and Edition.
Management of a Point-of-
Care Testing Program.
7-284................. Supplemental Tables for CLSI EP37 1st
Interference Testing in Edition.
Clinical Chemistry.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-479................. Implants for surgery-- ISO 13781 Second
Homopolymers, copolymers edition 2017-07.
and blends on
poly(lactide)--In vitro
degradation testing.
------------------------------------------------------------------------

[[Page 53270]]

J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-113................ American National Standard ANSI Z80.30-2018.
for Ophthalmics--Toric
Intraocular Lenses.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-336................ Wear of implant materials-- ISO 17853 Third
Polymer and metal wear edition 2011-03-01.
articles--Isolation and
characterization.
11-337................ Implants for surgery-- ISO 16087 First
Roentgen edition 2013-10-01.
stereophotogrammetric
analysis for the
assessment of migration
of orthopaedic implants.
11-338................ Implants for surgery-- ISO 11491 First
Determination of impact edition 2017-07.
resistance of ceramic
femoral heads for hip
joint prostheses.
11-339................ Implants for surgery-- ISO 7206-2 Third
Partial and total hip edition 2011-04-01
joint prostheses--Part 2: AMENDMENT 1 2016-09-
Articulating surfaces 15.
made of metallic, ceramic
and plastics materials
[Including AMENDMENT1
(2016)].
11-340................ Standard Guide for ASTM F3018-17.
Assessment of Hard-on-
Hard Articulation Total
Hip Replacement and Hip
Resurfacing Arthroplasty
Devices.
11-341................ Standard Test Method for ASTM F3140-17.
Cyclic Fatigue Testing of
Metal Tibial Tray
Components of Unicondylar
Knee Joint Replacements.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-318................ Medical electrical IEC 60601-2-64
equipment--Part 2-64: Edition 1.0 2014-
Particular requirements 09.
for the basic safety and
essential performance of
light ion beam medical
electrical equipment.
12-319................ Medical electrical IEC 60601-2-68
equipment--Part 2-68: Edition 1.0 2014-
Particular requirements 09.
for the basic safety and
essential performance of
X-ray-based image-guided
radiotherapy equipment
for use with electron
accelerators, light ion
beam therapy equipment
and radionuclide beam
therapy equipment.
12-320................ Medical electrical IEC 62667 Edition
equipment--Medical light 1.0 2017-08.
ion beam equipment--
Performance
characteristics.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-515................ Processing of health care ISO 17664 Second
products--Information to edition 2017-10.
be provided by the
medical device
manufacturer for the
processing of medical
devices.
14-516................ Standard Test Method for ASTM F3039-15.
Detecting Leaks in
Nonporous Packaging or
Flexible Barrier
Materials by Dye
Penetration.
14-517................ Standard Guide for ASTM F3293-18.
Application of Test Soils
for the Validation of
Cleaning Methods for
Reusable Medical Devices.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
15-55................. Standard Guide for Micro- ASTM F3259-17.
computed Tomography of
Tissue Engineered
Scaffolds.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

IV. List of Recognized Standards

FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet

[[Page 53271]]

appeared in the Federal Register). 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.

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
CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations
should contain, at a minimum, the following information available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22977 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53265

premarket review submissions or other These notices describe the addition, modifications to the list of FDA
requirements. withdrawal, and revision of certain Recognized Consensus Standards in the
In the Federal Register notice of standards recognized by FDA. The Agency’s searchable database. FDA is
September 13, 2018 (83 FR 46738), FDA Agency maintains hypertext markup using the term ‘‘Recognition List
language (HTML) and portable Number: 050’’ to identify the current
announced the availability of a guidance
document format (PDF) versions of the modifications.
entitled ‘‘Appropriate use of Voluntary
list of FDA Recognized Consensus In table 1, FDA describes the
Consensus Standards in Premarket Standards. Additional information on
Submission for Medical Devices.’’ The following modifications: (1) The
the Agency’s standards program is withdrawal of standards and their
guidance describes how FDA has available at https://www.fda.gov/
implemented its standard recognition replacement by others, if applicable; (2)
MedicalDevices/DeviceRegulationand the correction of errors made by FDA in
program and is available at https:// Guidance/Standards/default.htm.
www.fda.gov/downloads/Medical listing previously recognized standards;
Devices/DeviceRegulationandGuidance/ II. Modifications to the List of and (3) the changes to the
Recognized Standards, Recognition List supplementary information sheets of
GuidanceDocuments/ucm077295.pdf.
Number: 050 recognized standards that describe
Modifications to the initial list of
FDA is announcing the addition, revisions to the applicability of the
recognized standards, as published in standards.
the Federal Register, can be accessed at withdrawal, correction, and revision of
https://www.fda.gov/MedicalDevices/ certain consensus standards the Agency In section III, FDA lists modifications
DeviceRegulationandGuidance/ is recognizing for use in premarket the Agency is making that involve the
Standards/ucm123792.htm. submissions and other requirements for initial addition of standards not
devices. FDA is incorporating these previously recognized by FDA.

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old Replacement
recognition recognition Title of standard 1 Change 2
No. No.

A. Anesthesiology

1–85 .............. 1–139 ISO 80601–2–61 Second edition 2017–12 (Corrected version 2018–02) Medical Withdrawn and replaced
electrical equipment—Part 2–61: Particular requirements for basic safety and with newer version.
essential performance of pulse oximeter equipment.
1–96 .............. 1–140 ISO 80601–2–55 Second edition 2018–02 Medical electrical equipment—Part Withdrawn and replaced
2–55: Particular requirements for the basic safety and essential performance with newer version.
of respiratory gas monitors.

B. Biocompatibility

2–176 ............ 2–255 ISO 10993–11 Third edition 2017–09 Biological evaluation of medical devices— Withdrawn and replaced
Part 11: Tests for systemic toxicity. with newer version.
2–204 ............ 2–256 ASTM F720–17 Standard Practice for Testing Guinea Pigs for Contact Aller- Withdrawn and replaced
gens: Guinea Pig Maximization Test. with newer version.
2–233 ............ 2–257 ASTM F2382–17e1 Standard Test Method for Assessment of Circulating Blood- Withdrawn and replaced
Contacting Medical Device Materials on Partial Thromboplastin Time (PTT). with newer version.

C. Cardiovascular

3–110 ............ ........................ AAMI TIR41:2011/(R)2017 Technical Information Report Active implantable Reaffirmation.
medical devices—Guidance for designation of left ventricle and implantable
cardioverter defibrillator lead connectors and pulse generator connector cav-
ities for implantable pacemakers and implantable cardioverter defibrillators.
3–123 ............ 3–152 IEC 80601–2–30 Edition 1.1 2013–07 Medical electrical equipment—Part 2–30: Withdrawn and replaced
Particular requirements for the basic safety and essential performance of with newer version.
automated non-invasive sphygmomanometers.

D. Dental/Ear, Nose, and Throat (ENT)

4–214 ............ 4–242 ISO 10139–1 Third edition 2018–03 Dentistry—Soft lining materials for remov- Withdrawn and replaced
able dentures—Part 1: Materials for short-term use. with newer version.

E. General I (Quality Systems/Risk Management) (QS/RM)

5–42 .............. ........................ ASTM D903–98 (Reapproved 2017) Standard Test Method for Peel or Stripping Reaffirmation.
Strength of Adhesive Bonds.
daltland on DSKBBV9HB2PROD with NOTICES

F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)

19–8 .............. ........................ IEC 60601–1–2 Edition 4.0 2014–02 Medical electrical equipment—Part 1–2: Extent of recognition.
General requirements for basic safety and essential performance—Collateral
Standard: Electromagnetic disturbances—Requirements and tests.
19–19 ............ ........................ IEC TR 60601–4–2 Edition 1.0 2016–05 Medical electrical equipment—Part 4– Extent of recognition.
2: Guidance and interpretation—Electromagnetic immunity: performance of
medical electrical equipment and medical electrical systems.

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53266 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old Replacement
recognition recognition Title of standard 1 Change 2
No. No.

19–21 ............ 19–30 AIM Standard 7351731 Rev. 2.00 Medical Electrical Equipment and System Withdrawn and replaced
Electromagnetic Immunity Test for Exposure to Radio Frequency Identifica- with newer version.
tion Readers—An AIM Standard.

G. General Hospital/General Plastic Surgery (GH/GPS)

6–123 ............ ........................ ASTM E667–98 (Reapproved 2017) Standard Specification for Mer- Reaffirmation.
cury-in-Glass, Maximum Self-Registering Clinical Thermometers.
6–254 ............ ........................ ASTM F2100–11 (Reapproved 2018) Standard Specification for Performance of Reaffirmation.
Materials Used in Medical Face Masks.
6–301 ............ 6–408 ISO 10555–1 Second edition 2013–06–15 Intravascular catheters—Sterile and Withdrawn and replaced
single-use catheters—Part 1: General requirements [Including AMENDMENT with newer version includ-
1 (2017)]. ing amendment.
6–352 ............ 6–409 ASTM F703–18 Standard Specification for Implantable Breast Prostheses ......... Withdrawn and replaced
with newer version.

H. In Vitro Diagnostics (IVD)

7–127 ............ 7–275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry ....................... Withdrawn and replaced
with newer version.
7–171 ............ 7–276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Suscepti- Withdrawn and replaced
bility Testing of Filamentous Fungi. with newer version.
7–201 ............ 7–277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens ......... Withdrawn and replaced
with newer version.
7–204 ............ 7–278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Suscepti- Withdrawn and replaced
bility Testing of Yeasts. with newer version.
7–217 ............ ........................ CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Test- Title change.
ing of Yeasts.
7–240 ............ ........................ CLSI M27–S4 Reference Method for Broth Dilution Antifungal Susceptibility Withdrawn. See 7–217.
Testing of Yeasts; Fourth Informational Supplement.
7–245 ............ ........................ CLSI EP09–A3 Measurement Procedure Comparison and Bias Estimation Withdrawn.
Using Patient Samples; Approved Guideline—Third Edition.
7–254 ............ 7–279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests Withdrawn and replaced
for Bacteria That Grow Aerobically. with newer version.
7–258 ............ 7–280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Suscepti- Withdrawn and replaced
bility Tests. with newer version.
7–271 ............ 7–281 CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Withdrawn and replaced
Testing. with newer version.

I. Materials

8–57 .............. 8–465 ISO 5832–2 Fourth edition 2018–03 Implants for surgery—Metallic materials— Withdrawn and replaced
Part 2: Unalloyed titanium. with newer version.
8–112 ............ ........................ ASTM F1044–05 (Reapproved 2017)e1 Standard Test Method for Shear Test- Reaffirmation.
ing of Calcium Phosphate Coatings and Metallic Coatings.
8–128 ............ 8–466 ASTM F2213–17 Standard Test Method for Measurement of Magnetically In- Withdrawn and replaced
duced Torque on Medical Devices in the Magnetic Resonance Environment. with newer version.
8–330 ............ 8–467 ASTM F1978–18 Standard Test Method for Measuring Abrasion Resistance of Withdrawn and replaced
Metallic Thermal Spray Coatings by Using the Taber Abraser. with newer version.
8–334 ............ 8–468 ASTM F2459–18 Standard Test Method for Extracting Residue from Metallic Withdrawn and replaced
Medical Components and Quantifying via Gravimetric Analysis. with newer version.
8–372 ............ 8–469 ASTM F560–17 Standard Specification for Unalloyed Tantalum for Surgical Im- Withdrawn and replaced
plant Applications (UNS R05200, UNS R05400). with newer version.
8–380 ............ ........................ ASTM F1160–14 (Reapproved 2017)e1 Standard Test Method for Shear and Reaffirmation.
Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and
Composite Calcium Phosphate/Metallic Coatings.
8–382 ............ 8–470 ASTM F2102–17 Standard Guide for Evaluating the Extent of Oxidation in Poly- Withdrawn and replaced
ethylene Fabricated Forms Intended for Surgical Implants. with newer version.
8–390 ............ 8–471 ASTM F1925–17 Standard Specification for Semi-Crystalline Poly(lactide) Poly- Withdrawn and replaced
mer and Copolymer Resins for Surgical Implants. with newer version.
8–412 ............ ........................ ASTM F2537–06 (Reapproved 2017) Standard Practice for Calibration of Linear Reaffirmation.
daltland on DSKBBV9HB2PROD with NOTICES

Displacement Sensor Systems Used to Measure Micromotion.
8–414 ............ 8–472 ASTM F2847–17 Standard Practice for Reporting and Assessment of Residues Withdrawn and replaced
on Single-Use Implants and Single-Use Sterile Instruments. with newer version.
8–419 ............ 8–473 ASTM F2885–17 Standard Specification for Metal Injection Molded Titanium- Withdrawn and replaced
6Aluminum-4Vanadium Components for Surgical Implant Applications. with newer version. Extent
of recognition.
8–420 ............ 8–474 ASTM F2886–17 Standard Specification for Metal Injection Molded Cobalt- Withdrawn and replaced
28Chromium-6Molybdenum Components for Surgical Implant Applications. with newer version.

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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53267

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old Replacement
recognition recognition Title of standard 1 Change 2
No. No.

8–436 ............ 8–475 ASTM F2026–17 Standard Specification for Polyetheretherketone (PEEK) Poly- Withdrawn and replaced
mers for Surgical Implant Applications. with newer version.
8–448 ............ 8–476 ASTM F2004–17 Standard Test Method for Transformation Temperature of Withdrawn and replaced
Nickel-Titanium Alloys by Thermal Analysis. with newer version.
8–454 ............ 8–477 ASTM F2129–17b Standard Test Method for Conducting Cyclic Withdrawn and replaced
Potentiodynamic Polarization Measurements to Determine the Corrosion Sus- with newer version.
ceptibility of Small Implant Devices.

J. Nanotechnology
No new entries at this time.

K. Neurology
No new entries at this time.

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)

9–43 .............. 9–117 ISO 16038 Second edition 2017–11 Male condoms—Guidance on the use of Withdrawn and replaced
ISO 4074 and ISO 23409 in the quality management of condoms. with newer version.
9–67 .............. ........................ ASTM D7661–10 (Reapproved 2017) Standard Test Method for Determining Reaffirmation.
Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
9–92 .............. 9–118 ISO 8637–1 First edition 2017–11 Extracorporeal systems for blood purifi- Withdrawn and replaced
cation—Part 1: Haemodialysers, haemodiafilters, haemofilters and with newer version.
haemoconcentrators.
9–95 .............. 9–119 IEC 60601–2–36 Edition 2.0 2014–04 Medical electrical equipment—Part 2–36: Withdrawn and replaced
Particular requirements for the safety of equipment for extracorporeally in- with new recognition num-
duced lithotripsy. ber.
9–112 ............ 9–120 ASTM D3492–16 Standard Specification for Rubber Contraceptives (Male Withdrawn and replaced
Condoms). with newer version.

M. Ophthalmic

10–56 ............ ........................ ANSI Z80.12–2007 (R2017) American National Standard for Ophthalmics— Reaffirmation.
Multifocal Intraocular Lenses.
10–57 ............ ........................ ANSI Z80.13–2007 (R2017) American National Standard for Ophthalmics— Reaffirmation.
Phakic Intraocular Lenses.
10–60 ............ 10–111 ISO 11981 Third edition 2017–11 Ophthalmic optics—Contact lenses and con- Withdrawn and replaced
tact lens care products—Determination of physical compatibility of contact with newer version.
lens care products with contact lenses.
10–67 ............ 10–112 ISO 11986 Third edition 2017–11 Ophthalmic optics—Contact lenses and con- Withdrawn and replaced
tact lens care products—Determination of preservative uptake and release. with newer version.
10–84 ............ ........................ ANSI Z80.11–2012 (R2017) American National Standard for Ophthalmics— Reaffirmation.
Laser Systems for Corneal Reshaping.

N. Orthopedic

11–185 .......... ........................ ASTM F2267–04 (Reapproved 2018) Standard Test Method for Measuring Reaffirmation.
Load Induced Subsidence of Intervertebral Body Fusion Device Under Static
Axial Compression.
11–197 .......... ........................ ASTM F983–86 (Reapproved 2018) Standard Practice for Permanent Marking Reaffirmation.
of Orthopaedic Implant Components.
11–199 .......... ........................ ASTM F565–04 (Reapproved 2018) Standard Practice for Care and Handling of Reaffirmation.
Orthopedic Implants and Instruments.
11–203 .......... 11–322 ASTM F1541–17 Standard Specification and Test Methods for External Skeletal Withdrawn and replaced
Fixation Devices. with newer version.
11–224 .......... 11–323 ASTM F2706–17 Standard Test Methods for Occipital-Cervical and Occipital- Withdrawn and replaced
Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. with newer version.
11–226 .......... 8–478 ASTM F1089–18 Standard Test Method for Corrosion of Surgical Instruments .. Withdrawn and replaced
with newer version. Trans-
ferred.
11–227 .......... 11–324 ASTM F366–17 Standard Specification for Fixation Pins and Wires .................... Withdrawn and replaced
with newer version.
daltland on DSKBBV9HB2PROD with NOTICES

11–228 .......... 11–325 ASTM F564–17 Standard Specification and Test Methods for Metallic Bone Withdrawn and replaced
Staples. with newer version.
11–245 .......... 11–326 ASTM F384–17 Standard Specifications and Test Methods for Metallic Angled Withdrawn and replaced
Orthopedic Fracture Fixation Devices. with newer version.
11–257 .......... 11–327 ASTM F543–17 Standard Specification and Test Methods for Metallic Medical Withdrawn and replaced
Bone Screws. with newer version.
11–261 .......... 11–328 ASTM F1378–17 Standard Specification for Shoulder Prostheses ...................... Withdrawn and replaced
with newer version.

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$Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53269 III. Listing of New Entries added as modifications to the list of In table 2, FDA provides the listing of recognized standards under Recognition new entries and consensus standards List Number: 050. TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition Title of standard 1 Reference No. and date No. A. Anesthesiology No new entries at this time. B. Biocompatibility No new entries at this time. C. Cardiovascular 3–153 ........... Standard Guide for Coating Inspection and Acute Particulate Characterization of ASTM F2743–11. Coated Drug-Eluting Vascular Stent Systems. 3–154 ........... Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Med- ASTM F3211–17. ical Devices. 3–155 ........... Medical electrical equipment—Part 2–47: Particular requirements for the basic safe- IEC 60601–2–47 Edition 2.0 2012–02. ty and essential performance of ambulatory electrocardiographic systems. 3–156 ........... Implants for surgery—Active implantable medical devices—Part 1: General require- ISO 14708–1 Second edition 2014–08– ments for safety, marking and for information to be provided by the manufacturer. 15. D. Dental/Ear, Nose, and Throat (ENT) 4–243 ........... Corrosion Test Methods ................................................................................................ ANSI/ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013. 4–244 ........... Dentistry—Test methods for rotary instruments ........................................................... ISO 8325 Second edition 2004–09–15. 4–245 ........... Dentistry—Corrosion test methods for metallic materials ............................................ ISO 10271 Second edition 2011–08–01. 4–246 ........... Dentistry—Pre-capsulated dental amalgam ................................................................. ISO 20749 First edition 2017–03. 4–247 ........... Dentistry—Laser welding and filler materials ............................................................... ISO 28319 Second edition 2018–04. E. General I (Quality Systems/Risk Management) (QS/RM) 5–118 ........... Guidance for the creation of physiologic data and waveform databases to dem- AAMI TIR66:2017. onstrate reasonable assurance of the safety and effectiveness of alarm system algorithms. 5–119 ........... Medical devices—Connectors for reservoir delivery systems for healthcare applica- ISO 18250–3 First edition 2018–06. tions—Part 3: Enteral application. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–31 ........... American National Standard Recommended Practice for the Immunity Measurement ANSI C63.15–2017 (Revision of ANSI of Electrical and Electronic Equipment. C63.15–2016). G. General Hospital/General Plastic Surgery (GH/GPS) No new entries at this time. H. In Vitro Diagnostics (IVD) 7–282 ........... Performance Standards for Antifungal Susceptibility Testing of Yeasts ...................... CLSI M60 1st Edition. 7–283 ........... Essential Tools for Implementation and Management of a Point-of-Care Testing CLSI POCT04 3rd Edition. Program. 7–284 ........... Supplemental Tables for Interference Testing in Clinical Chemistry ........................... CLSI EP37 1st Edition. I. Materials 8–479 ........... Implants for surgery—Homopolymers, copolymers and blends on poly(lactide)—In ISO 13781 Second edition 2017–07. vitro degradation testing. daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1$

$53270 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition Title of standard 1 Reference No. and date No. J. Nanotechnology No new entries at this time. K. Neurology No new entries at this time. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) No new entries at this time. M. Ophthalmic 10–113 ......... American National Standard for Ophthalmics—Toric Intraocular Lenses .................... ANSI Z80.30–2018. N. Orthopedic 11–336 ......... Wear of implant materials—Polymer and metal wear articles—Isolation and charac- ISO 17853 Third edition 2011–03–01. terization. 11–337 ......... Implants for surgery—Roentgen stereophotogrammetric analysis for the assessment ISO 16087 First edition 2013–10–01. of migration of orthopaedic implants. 11–338 ......... Implants for surgery—Determination of impact resistance of ceramic femoral heads ISO 11491 First edition 2017–07. for hip joint prostheses. 11–339 ......... Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating sur- ISO 7206–2 Third edition 2011–04–01 faces made of metallic, ceramic and plastics materials [Including AMENDMENT1 AMENDMENT 1 2016–09–15. (2016)]. 11–340 ......... Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replace- ASTM F3018–17. ment and Hip Resurfacing Arthroplasty Devices. 11–341 ......... Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components ASTM F3140–17. of Unicondylar Knee Joint Replacements. O. Physical Medicine No new entries at this time. P. Radiology 12–318 ......... Medical electrical equipment—Part 2–64: Particular requirements for the basic safe- IEC 60601–2–64 Edition 1.0 2014–09. ty and essential performance of light ion beam medical electrical equipment. 12–319 ......... Medical electrical equipment—Part 2–68: Particular requirements for the basic safe- IEC 60601–2–68 Edition 1.0 2014–09. ty and essential performance of X-ray-based image-guided radiotherapy equip- ment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment. 12–320 ......... Medical electrical equipment—Medical light ion beam equipment—Performance IEC 62667 Edition 1.0 2017–08. characteristics. Q. Software/Informatics No new entries at this time. R. Sterility 14–515 ......... Processing of health care products—Information to be provided by the medical de- ISO 17664 Second edition 2017–10. vice manufacturer for the processing of medical devices. 14–516 ......... Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Bar- ASTM F3039–15. rier Materials by Dye Penetration. 14–517 ......... Standard Guide for Application of Test Soils for the Validation of Cleaning Methods ASTM F3293–18. for Reusable Medical Devices. S. Tissue Engineering 15–55 ........... Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds .... ASTM F3259–17. 1 All standard titles in this table conform to the style requirements of the respective organizations. daltland on DSKBBV9HB2PROD with NOTICES IV. List of Recognized Standards accessed at https://www.accessdata.fda. published in the Federal Register or gov/scripts/cdrh/cfdocs/cfStandards/ that FDA has decided to recognize but FDA maintains the current list of FDA search.cfm. Such standards are those for which recognition is pending Recognized Consensus Standards in a that FDA has recognized by notice (because a periodic notice has not yet searchable database that may be VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1$

Document Created: 2018-10-20 01:49:33
Document Modified: 2018-10-20 01:49:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018.
Contact		Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected]
FR Citation		83 FR 53264

83 FR 53264 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration