|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
12/18/2023 |
Cardiovascular |
3-190 |
Complete |
ISO |
PAS 7020 First edition 2023-05 |
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
12/18/2023 |
Orthopedic |
11-402 |
Complete |
ASTM |
F1798-21 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
08/14/2015 |
InVitro Diagnostics |
7-257 |
Complete |
CLSI |
M56-A |
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
01/30/2014 |
Physical Medicine |
16-164 |
Complete |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
09/17/2018 |
Ophthalmic |
10-84 |
Complete |
ANSI |
Z80.11-2012 (R2022) |
American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping |
09/17/2018 |
Ophthalmic |
10-113 |
Complete |
ANSI |
Z80.30-2018 (R2023) |
American National Standard for Ophthalmics - Toric Intraocular Lenses |
06/27/2016 |
Radiology |
12-301 |
Complete |
IEC |
60601-2-8 Edition 2.1 b:2015 |
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
06/07/2018 |
Materials |
8-464 |
Complete |
ISO |
TS 10974 Second edition 2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
01/14/2014 |
Radiology |
12-268 |
Complete |
IEC |
60601-2-22 Edition 3.1 2012-10 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
05/29/2024 |
Radiology |
12-354 |
Complete |
NEMA |
MS 4-2023 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
12/23/2024 |
Materials |
8-618 |
Complete |
ASTM |
F1350-24 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
04/04/2016 |
Materials |
8-393 |
Complete |
ASTM |
F1350-15 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
12/23/2024 |
Materials |
8-625 |
Complete |
ASTM |
F1295-24 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
08/14/2015 |
Software/ Informatics |
13-78 |
Complete |
INCITS ISO IEC |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
06/27/2016 |
Sterility |
14-481 |
Complete |
ISO |
14644-2 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
06/27/2016 |
Sterility |
14-483 |
Complete |
ISO ASTM |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
04/04/2016 |
Tissue Engineering |
15-43 |
Complete |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-407 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
06/07/2018 |
Tissue Engineering |
15-53 |
Complete |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
06/07/2018 |
Materials |
8-463 |
Complete |
ISO ASTM |
52901 First edition 2017-08 |
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts |
12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
06/07/2018 |
Anesthesiology |
1-136 |
Complete |
ISO |
18562-3 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
07/06/2020 |
Software/ Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
07/09/2014 |
General I (QS/ RM) |
5-88 |
Complete |
ISO |
2859-1 Second edition 1999-11-15 |
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)] |
06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
06/27/2016 |
Dental/ ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
01/30/2014 |
Physical Medicine |
16-167 |
Complete |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
01/30/2014 |
Radiology |
12-262 |
Complete |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
07/09/2014 |
InVitro Diagnostics |
7-48 |
Complete |
CLSI |
C60-A |
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
05/29/2024 |
Sterility |
14-600 |
Complete |
ASTM |
F1929-23 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
08/14/2015 |
InVitro Diagnostics |
7-251 |
Complete |
CLSI |
EP05-A3 (Reaffirmed: September 2019) |
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
08/14/2015 |
InVitro Diagnostics |
7-252 |
Complete |
CLSI |
EP14-A3 |
Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
04/04/2016 |
Materials |
8-135 |
Complete |
ASTM |
F2392-04 (Reapproved 2015) |
Standard Test Method for Burst Strength of Surgical Sealants |
01/27/2015 |
Materials |
8-383 |
Complete |
ASTM |
F1926/F1926M-14 |
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
12/23/2019 |
Materials |
8-494 |
Complete |
ISO |
6474-1 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
12/23/2019 |
Materials |
8-522 |
Complete |
ASTM |
F2129-19a |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
12/23/2024 |
Materials |
8-627 |
Complete |
ASTM |
F3604-23 |
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion. |
12/23/2024 |
Materials |
8-626 |
Complete |
ASTM |
E2948-24 |
Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire |
09/17/2018 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
09/17/2018 |
Dental/ ENT |
4-242 |
Complete |
ISO |
10139-1 Third edition 2018-03 |
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
ANSI ADA |
Standard No. 75-2020 |
Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-119 |
Complete |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
09/17/2018 |
Cardiovascular |
3-153 |
Complete |
ASTM |
F2743-11 |
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
09/17/2018 |
InVitro Diagnostics |
7-284 |
Complete |
CLSI |
EP37 1st Edition |
Supplemental Tables for Interference Testing in Clinical Chemistry |
09/17/2018 |
InVitro Diagnostics |
7-277 |
Complete |
CLSI |
GP41 7th Edition |
Collection of Diagnostic Venous Blood Specimens |
09/17/2018 |
InVitro Diagnostics |
7-278 |
Complete |
CLSI |
M27 4th Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
12/18/2023 |
Orthopedic |
11-406 |
Complete |
ASTM |
F3141-23 |
Standard Guide for Total Knee Replacement Loading Profiles |
09/09/2008 |
Sterility |
14-239 |
Complete |
ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
06/07/2018 |
Neurology |
17-15 |
Complete |
ISO |
14708-3 Second edition 2017-04 |
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
06/07/2018 |
Neurology |
17-16 |
Complete |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
05/29/2024 |
Sterility |
14-601 |
Complete |
ISO |
17665 First edition 2024-03 |
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
07/09/2014 |
Sterility |
14-434 |
Complete |
ASTM |
F2228-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method |
07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
07/09/2014 |
Sterility |
14-435 |
Complete |
ASTM |
F2251-13 (Reapproved 2023) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
07/15/2019 |
Tissue Engineering |
15-58 |
Complete |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
01/14/2019 |
Software/ Informatics |
13-107 |
Complete |
ISO IEEE |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services |
05/29/2023 |
Radiology |
12-351 |
Complete |
IEC |
60601-2-43 Edition 3.0 2022-12 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
05/29/2024 |
Sterility |
14-603 |
Complete |
AAMI |
TIR28:2016/(R)2020 |
Product adoption and process equivalence for ethylene oxide sterilization |
09/17/2018 |
Orthopedic |
11-338 |
Complete |
ISO |
11491 First edition 2017-07 |
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-117 |
Complete |
ISO |
16038 Second edition 2017-11 |
Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-120 |
Complete |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
09/17/2018 |
Physical Medicine |
16-202 |
Complete |
ISO |
7176-2 Third edition 2017-10 |
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
05/29/2024 |
Sterility |
14-602 |
Complete |
AAMI |
TIR12:2020/(R)2023 |
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
11/08/2005 |
Radiology |
12-6 |
Complete |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
05/29/2023 |
InVitro Diagnostics |
7-315 |
Complete |
CLSI |
EP12 3rd Edition |
Evaluation of Qualitative, Binary Output Examination Performance |
01/30/2014 |
InVitro Diagnostics |
7-152 |
Complete |
CLSI |
EP12-A2 |
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
01/30/2014 |
InVitro Diagnostics |
7-244 |
Complete |
CLSI |
NBS01-A6 (Replaces LA04-A5) |
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
08/14/2015 |
InVitro Diagnostics |
7-253 |
Complete |
CLSI |
EP15-A3 (Reaffirmed: September 2019) |
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
06/27/2016 |
Radiology |
12-297 |
Complete |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
06/27/2016 |
Radiology |
12-298 |
Complete |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-380 |
Complete |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
01/14/2019 |
Sterility |
14-518 |
Complete |
AAMI ANSI |
ST55:2016/(R)2023 |
Table-top steam sterilizers |
09/17/2018 |
Orthopedic |
11-335 |
Complete |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
04/04/2016 |
Cardiovascular |
3-125 |
Complete |
ISO |
5841-3 Third edition 2013-04-15 |
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers |
03/16/2012 |
InVitro Diagnostics |
7-166 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
01/15/2013 |
Software/ Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
01/15/2013 |
General Plastic Surgery/ General Hospital |
6-122 |
Complete |
ISO |
8536-5 Second edition 2004-02-01 |
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
03/16/2012 |
InVitro Diagnostics |
7-227 |
Complete |
CLSI |
M53-A (Replaces M53-P) |
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
03/16/2012 |
Radiology |
12-242 |
Complete |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
12/23/2024 |
Materials |
8-619 |
Complete |
ISO |
5832-4 Fourth edition 2024-04 |
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy |
12/23/2024 |
Materials |
8-620 |
Complete |
ISO |
5832-11 Third edition 2024-03 |
Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
12/23/2024 |
Materials |
8-622 |
Complete |
ASTM |
F2004-24 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
09/17/2018 |
Materials |
8-476 |
Complete |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
01/15/2013 |
Software/ Informatics |
13-35 |
Complete |
ANSI AAMI |
SW87:2012 |
Application of quality management system concepts to medical device data systems |
01/15/2013 |
Software/ Informatics |
13-36 |
Complete |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
01/15/2013 |
Sterility |
14-213 |
Complete |
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 |
Complete |
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 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
03/16/2012 |
Anesthesiology |
1-72 |
Complete |
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 |
12/20/2021 |
Materials |
8-565 |
Complete |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
12/19/2022 |
Nanotechnology |
18-21 |
Complete |
ISO |
TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |