|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/20/2021 |
Biocompatibility |
2-292 |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/20/2021 |
Biocompatibility |
2-293 |
USP-NF |
M98833_01_01 |
<87> Biological Reactivity Test, In Vitro - Elution Test |
03/16/2012 |
Radiology |
12-134 |
ISO |
11146-1 First edition 2005-01-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
08/20/2012 |
InVitro Diagnostics |
7-148 |
CLSI |
M28-A2 (Replaces M28-A) |
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. |
03/16/2012 |
Software/ Informatics |
13-30 |
CLSI |
AUTO3-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard |
03/16/2012 |
General Plastic Surgery/ General Hospital |
6-268 |
ASTM |
F921-10 (Reapproved 2018) |
Standard Terminology Relating to Hemostatic Forceps |
01/30/2014 |
Orthopedic |
11-274 |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
03/16/2012 |
Dental/ ENT |
4-173 |
ANSI ASA |
S3.44-1996 (Reaffirmed 2006) |
American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment |
04/04/2016 |
Materials |
8-399 |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
01/15/2013 |
Sterility |
14-213 |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-215 |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-217 |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
03/16/2012 |
Anesthesiology |
1-72 |
ANSI AAMI ISO |
10651-5:2006 |
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
ISO |
10651-5 First edition 2006-02-01 |
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
08/06/2013 |
Ophthalmic |
10-78 |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
01/27/2015 |
Sterility |
14-242 |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
03/16/2012 |
Radiology |
12-106 |
ISO |
17526 First edition 2003-06-15 |
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers |
03/16/2012 |
Radiology |
12-246 |
ISO |
21254-2 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination |
03/16/2012 |
Radiology |
12-245 |
ISO |
21254-1 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles |
08/20/2012 |
General Plastic Surgery/ General Hospital |
6-242 |
ISO |
8536-2 Third edition 2010-03-15 |
Infusion equipment for medical use - Part 2: Closures for infusion bottles |
01/15/2013 |
Sterility |
14-359 |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
03/16/2012 |
General Plastic Surgery/ General Hospital |
6-269 |
ASTM |
F1078-10 (Reapproved 2018) |
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
03/16/2012 |
General Plastic Surgery/ General Hospital |
6-271 |
ASTM |
F1874-98 (Reapproved 2011) |
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
12/23/2016 |
Orthopedic |
11-311 |
ISO |
14243-2 Third edition 2016-09-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement |
03/31/2006 |
Radiology |
12-141 |
IEEE |
N42.13-2004 |
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
12/23/2016 |
Tissue Engineering |
15-48 |
ASTM |
F2605-16 |
Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-322 |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
01/30/2014 |
InVitro Diagnostics |
7-244 |
CLSI |
NBS01-A6 (Replaces LA04-A5) |
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
01/30/2014 |
InVitro Diagnostics |
7-224 |
CLSI |
EP28-A3c (Formerly C28-A3c) |
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
07/26/2016 |
Biocompatibility |
2-174 |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-390 |
ANSI AAMI IEC |
80601-2-35:2009/A1:2016 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use |
IEC |
80601-2-35 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)] |
12/19/2022 |
Orthopedic |
11-394 |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
01/30/2014 |
Orthopedic |
11-264 |
ASTM |
F1820-13 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
08/06/2013 |
Software/ Informatics |
13-60 |
IEC |
/TS 62443-1-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
08/06/2013 |
Software/ Informatics |
13-62 |
IEC |
/TR 62443-3-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems |
01/30/2014 |
Dental/ ENT |
4-199 |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
01/30/2014 |
Physical Medicine |
16-27 |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
01/30/2014 |
Physical Medicine |
16-163 |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-295 |
ANSI AAMI |
BF7:2012 |
Blood transfusion microfilters |
08/14/2015 |
Materials |
8-389 |
ISO |
15309 First edition 2013-12-01 |
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
08/14/2015 |
Orthopedic |
11-294 |
ASTM |
F1357 -14 (Reapproved 2019) |
Standard Specification for Articulating Total Wrist Implants |
08/14/2015 |
Radiology |
12-292 |
IEEE |
Std 3333.2.1-2015 |
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
06/07/2018 |
Ophthalmic |
10-109 |
ISO |
18369-1 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications |
01/30/2014 |
Anesthesiology |
1-81 |
CGA |
V-5:2008 (Reaffirmed 2013) |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
07/09/2014 |
Radiology |
12-194 |
ANSI HPS |
N43.6-2007 (R2013) |
Sealed Radioactive Sources - Classification |
05/30/2022 |
Radiology |
12-343 |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
07/09/2014 |
Radiology |
12-277 |
IEC |
62127-1 Edition 1.1 2013-02 |
Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz |
08/21/2017 |
Software/ Informatics |
13-90 |
IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
06/27/2016 |
Materials |
8-427 |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
12/23/2016 |
Physical Medicine |
16-199 |
ISO |
7176-28 First edition 2012-10-1 |
Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-402 |
ASTM |
F1670/F1670M-17 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
08/21/2017 |
Materials |
8-458 |
ASTM |
G5-14 |
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements |
01/30/2014 |
InVitro Diagnostics |
7-223 |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
12/23/2016 |
Sterility |
14-169 |
ASTM |
F2391-05 (Reapproved 2016) |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
07/09/2014 |
Sterility |
14-256 |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
09/17/2018 |
Dental/ ENT |
4-244 |
ISO |
8325 Second edition 2004-09-15 |
Dentistry - Test methods for rotary instruments |
09/17/2018 |
Orthopedic |
11-336 |
ISO |
17853 Third edition 2011-03-01 |
Wear of implant materials - Polymer and metal wear particles - Isolation and characterization |
12/20/2021 |
Cardiovascular |
3-178 |
ASTM |
F3067 - 14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
12/19/2022 |
Materials |
8-594 |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
04/04/2016 |
Materials |
8-405 |
ISO |
5832-4 Third edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
12/23/2016 |
Materials |
8-435 |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
12/23/2016 |
Materials |
8-368 |
ASTM |
F2625-10 (Reapproved 2016) |
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
01/30/2014 |
Sterility |
14-395 |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
01/30/2014 |
Sterility |
14-397 |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
01/30/2014 |
Sterility |
14-398 |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
01/30/2014 |
Sterility |
14-399 |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
12/19/2022 |
Cardiovascular |
3-183 |
ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
01/14/2019 |
Dental/ ENT |
4-217 |
ANSI ASA |
S3.36-2012 (Reaffirmed 2018) |
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
12/19/2022 |
Physical Medicine |
16-233 |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
09/17/2018 |
General II (ES/ EMC) |
19-31 |
ANSI IEEE |
C63.15-2017 (Revision of ANSI C63.15-2010) |
American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment |
09/17/2018 |
Radiology |
12-319 |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements 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 |
09/17/2018 |
General I (QS/ RM) |
5-42 |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
09/17/2018 |
Ophthalmic |
10-57 |
ANSI |
Z80.13-2007 (R2017) |
American National Standard for Ophthalmics - Phakic Intraocular Lenses |
09/17/2018 |
Ophthalmic |
10-111 |
ISO |
11981 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
12/21/2020 |
Materials |
8-551 |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
07/09/2014 |
Sterility |
14-435 |
ASTM |
F2251-13 (Reapproved 2018) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
07/09/2014 |
Sterility |
14-290 |
ANSI AAMI |
ST24:1999/(R)2018 |
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed. |
07/09/2014 |
Tissue Engineering |
15-40 |
ASTM |
F2211-13 |
Standard Classification for Tissue Engineered Medical Products (TEMPs) |
08/14/2015 |
InVitro Diagnostics |
7-253 |
CLSI |
EP15-A3 (Reaffirmed: September 2019) |
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
06/27/2016 |
Radiology |
12-297 |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
08/06/2013 |
Physical Medicine |
16-191 |
ISO |
7176-16 Second edition 2012-12-01 |
Wheelchairs - Part 16: Resistance to ignition of postural support devices |
08/14/2015 |
Sterility |
14-465 |
ASTM ISO |
51707 Third edition 2015-03-15 |
Guide for estimating uncertainties in dosimetry for radiation processing |
04/04/2016 |
Materials |
8-400 |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
04/04/2016 |
Materials |
8-403 |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
04/04/2016 |
Materials |
8-408 |
ASTM |
F3122-14 |
Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes |
08/06/2013 |
Orthopedic |
11-252 |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
09/21/2016 |
InVitro Diagnostics |
7-266 |
CLSI |
EP19 2nd Edition (Replaces EP19-R) |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
08/14/2015 |
Sterility |
14-463 |
ASTM ISO |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
ASTM |
D3772-15 |
Standard Specification for Industrial Rubber Finger Cots |
01/27/2015 |
Radiology |
12-230 |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
01/27/2015 |
Radiology |
12-286 |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
06/27/2016 |
Radiology |
12-294 |
IEC |
60601-2-45 Edition 3.1 2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
07/09/2014 |
General II (ES/ EMC) |
19-11 |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
08/06/2013 |
Physical Medicine |
16-190 |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
08/06/2013 |
Physical Medicine |
16-192 |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
04/04/2016 |
Radiology |
12-288 |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
07/09/2014 |
InVitro Diagnostics |
7-175 |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
07/09/2014 |
Dental/ ENT |
4-97 |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
01/30/2014 |
Physical Medicine |
16-165 |
ISO |
7176-14 Second edition 2008-02-15 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
05/30/2022 |
Radiology |
12-345 |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
07/15/2019 |
Cardiovascular |
3-137 |
ASTM |
F3036-13 |
Standard Guide for Testing Absorbable Stents |