|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 07/15/2019 |
Ophthalmic |
10-117 |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 07/15/2019 |
InVitro Diagnostics |
7-287 |
CLSI |
M44-S3 (2018) |
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement |
| 01/14/2019 |
Materials |
8-489 |
ASTM |
F3302-18 |
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
| 01/14/2019 |
Orthopedic |
11-343 |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| 12/23/2019 |
Materials |
8-524 |
ASTM |
F3276-19 |
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device |
| 07/15/2019 |
InVitro Diagnostics |
7-288 |
CLSI |
M24 3rd Edition |
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
| 01/14/2019 |
InVitro Diagnostics |
7-286 |
CLSI |
M11 9th Edition |
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| 07/06/2020 |
Orthopedic |
11-363 |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| 12/23/2019 |
Radiology |
12-309 |
IEC |
60601-2-28 Edition 3.0 2017-06 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| 12/23/2019 |
Radiology |
12-327 |
ISO |
11551 Third eidtion 2019-10 |
Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components |
| 12/23/2019 |
General II (ES/
EMC) |
19-33 |
IEC |
62133-2 Edition1.0 2017-02 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
| 07/06/2020 |
Tissue Engineering |
15-62 |
ASTM |
F2602-18 |
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
| 04/04/2016 |
Dental/
ENT |
4-190 |
ANSI ASA |
S3.35-2010 (Reaffirmed 2020) |
American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions |
| 08/21/2017 |
Dental/
ENT |
4-232 |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 08/06/2013 |
Software/
Informatics |
13-42 |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| 01/14/2019 |
Software/
Informatics |
13-79 |
ANSI AAMI IEC |
62304:2006/A1:2016 |
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
| IEC |
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
Medical device software - Software life cycle processes |
| 07/15/2019 |
Biocompatibility |
2-264 |
ASTM |
F2148-18 |
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). |
| 01/14/2019 |
Dental/
ENT |
4-163 |
ANSI ASA |
S3.5-1997 (Reaffirmed 2020) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 01/14/2019 |
Cardiovascular |
3-138 |
ASTM |
F2942-13 |
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents |
| 03/31/2006 |
Radiology |
12-137 |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
| 09/09/2008 |
Sterility |
14-142 |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
| 10/04/2010 |
Radiology |
12-215 |
IEC |
62494-1 Edition 1.0 (2008-08) |
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| 03/16/2012 |
Tissue Engineering |
15-31 |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
| 08/06/2013 |
Software/
Informatics |
13-53 |
IEEE ISO |
11073-10415 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
| 12/04/2017 |
Software/
Informatics |
13-101 |
IEC ISO |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
| 01/14/2019 |
Biocompatibility |
2-136 |
ASTM |
E1262-88 (Reapproved 2018) |
Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 07/06/2020 |
Dental/
ENT |
4-263 |
ISO |
9693 Third edition 2019-10 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| 07/09/2014 |
Software/
Informatics |
13-15 |
CLSI |
AUTO13-A2 (Formerly GP19-A2) |
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
| 06/27/2016 |
Dental/
ENT |
4-228 |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
| 08/14/2015 |
InVitro Diagnostics |
7-252 |
CLSI |
EP14-A3 |
Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
| 06/07/2018 |
Materials |
8-113 |
ASTM |
F1147-05 (Reapproved 2017)e1 |
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| 01/14/2019 |
Biocompatibility |
2-145 |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 08/21/2017 |
Biocompatibility |
2-247 |
ISO |
10993-6 Third edition 2016-12-01 |
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |
| 07/09/2014 |
Sterility |
14-433 |
ASTM |
F2227-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
| 01/27/2015 |
Orthopedic |
11-281 |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
| 08/14/2015 |
Software/
Informatics |
13-74 |
IEEE |
Std 11073-10424-2014 |
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) |
| 01/27/2015 |
Sterility |
14-141 |
ISO |
14644-4 First edition 2001-04-01 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
| 06/15/2016 |
General I (QS/
RM) |
5-102 |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
| 12/23/2019 |
General II (ES/
EMC) |
19-32 |
IEC |
62133-1 Edition 1.0 2017-02 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems |
| 07/06/2020 |
Software/
Informatics |
13-113 |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-439 |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 01/14/2014 |
Radiology |
12-268 |
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 |
| 04/04/2016 |
Materials |
8-135 |
ASTM |
F2392-04 (Reapproved 2015) |
Standard Test Method for Burst Strength of Surgical Sealants |
| 01/27/2015 |
Materials |
8-383 |
ASTM |
F1926/F1926M-14 |
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
| 07/09/2014 |
Software/
Informatics |
13-69 |
IEEE ISO |
11073-10472 First edition 2012-11-01 |
Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor |
| 07/09/2014 |
Sterility |
14-434 |
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 |
| 07/15/2019 |
Anesthesiology |
1-143 |
ISO |
80601-2-79 First edition 2018-07 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 03/16/2012 |
Anesthesiology |
1-62 |
ANSI AAMI ISO |
5356-1:2004 |
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets |
| ISO |
5356-1 Third edition 2004-05-15 |
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
| 09/17/2018 |
Materials |
8-472 |
ASTM |
F2847-17 |
Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 01/14/2019 |
Cardiovascular |
3-66 |
ASTM |
F2081-06 (Reapproved 2017) |
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 01/14/2019 |
Sterility |
14-518 |
ANSI AAMI |
ST55:2016 |
Table-top steam sterilizers |
| 07/26/2016 |
Biocompatibility |
2-170 |
ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
| ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
| 01/14/2019 |
Neurology |
17-14 |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 06/07/2018 |
Materials |
8-464 |
ISO |
/TS 10974 Second edition 2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| 04/04/2016 |
Sterility |
14-333 |
ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
| ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 07/26/2016 |
Biocompatibility |
2-213 |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
| 01/14/2019 |
Physical Medicine |
16-204 |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-441 |
ISO |
7886-3 Second edition 2020-05 |
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| 09/17/2018 |
Materials |
8-474 |
ASTM |
F2886-17 |
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications |
| 09/17/2018 |
Materials |
8-475 |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 01/14/2019 |
InVitro Diagnostics |
7-178 |
CLSI |
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
| 12/23/2019 |
Materials |
8-519 |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| 01/14/2019 |
Radiology |
12-102 |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
| 09/17/2018 |
InVitro Diagnostics |
7-275 |
CLSI |
EP07 3rd Edition |
Interference Testing in Clinical Chemistry. |
| 09/17/2018 |
InVitro Diagnostics |
7-276 |
CLSI |
M38 3rd Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi |
| 09/17/2018 |
Orthopedic |
11-337 |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
| 09/17/2018 |
Orthopedic |
11-339 |
ISO |
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
| 01/30/2014 |
Dental/
ENT |
4-181 |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
| 07/06/2020 |
Orthopedic |
11-369 |
ASTM |
F3292-19 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 08/21/2017 |
General I (QS/
RM) |
5-107 |
ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| IEC |
80369-5: Edition 1.0 2016-03 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] |
| 01/30/2014 |
Sterility |
14-427 |
ANSI AAMI ISO |
13408-1:2008 (R2011) |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| 06/07/2018 |
Nanotechnology |
18-10 |
ISO |
29701 First edition 2010-09-15 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test. |
| 07/15/2019 |
Orthopedic |
11-349 |
ISO |
14242-3 First edition 2009-03-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
| 12/21/2020 |
Materials |
8-542 |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| 09/17/2018 |
Orthopedic |
11-335 |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
| 08/06/2013 |
Software/
Informatics |
13-40 |
ANSI AAMI IEC |
TIR 80001-2-1 2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples |
| IEC |
TR 80001-2-1 Edition 1.0 2012-07 |
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples |
| 08/06/2013 |
Software/
Informatics |
13-44 |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-422 |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
| 07/06/2020 |
Sterility |
14-543 |
ANSI AAMI ISO |
TIR 11139:2006 |
Sterilization of health care products - Vocabulary |
| ISO |
11139 First edition 2018-08 |
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
| 07/06/2020 |
Sterility |
14-544 |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-421 |
ISO |
80601-2-56 Second edition 2017-03 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
| 12/21/2020 |
Dental/
ENT |
4-266 |
ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| 09/17/2018 |
Orthopedic |
11-322 |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 09/17/2018 |
Materials |
8-467 |
ASTM |
F1978-18 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
| 09/17/2018 |
Materials |
8-468 |
ASTM |
F2459-18 |
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| 01/14/2019 |
Dental/
ENT |
4-162 |
ANSI ASA |
S3.4-2007 (Reaffirmed 2017) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 06/07/2018 |
Anesthesiology |
1-135 |
ISO |
18562-2 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
| 06/07/2018 |
Anesthesiology |
1-136 |
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 |
| 07/09/2014 |
Software/
Informatics |
13-68 |
ISO |
11073-90101 First edition 2008-01-15 |
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
| 04/04/2016 |
Software/
Informatics |
13-81 |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 07/15/2019 |
Materials |
8-510 |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-409 |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
| 09/17/2018 |
Sterility |
14-512 |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
| ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
| 09/17/2018 |
Sterility |
14-275 |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| 09/17/2018 |
Dental/
ENT |
4-242 |
ANSI ADA |
Standard No. 75-2020 |
Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
| ISO |
10139-1 Third edition 2018-03 |
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
| 01/14/2019 |
Orthopedic |
11-272 |
ASTM |
F1714-96 (Reapproved 2018) |
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| 01/30/2014 |
Sterility |
14-403 |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
| 08/14/2015 |
Orthopedic |
11-183 |
ASTM |
F1875-98 (Reapproved 2014) |
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface |
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