|
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)
|
08/06/2013 |
Software/ Informatics |
13-62 |
Complete |
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 |
12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
12/23/2019 |
Materials |
8-502 |
Complete |
ASTM |
F2038-18 |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
08/21/2017 |
Software/ Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
01/27/2015 |
Dental/ ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2019) |
American National Standard Procedures for Testing Basic Vestibular Function |
07/09/2014 |
Dental/ ENT |
4-211 |
Complete |
ANSI ASA |
S3.46-2013 (Reaffirmed 2023) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
01/30/2014 |
Sterility |
14-403 |
Complete |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
01/14/2019 |
Materials |
8-487 |
Complete |
ISO ASTM |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
12/18/2023 |
Anesthesiology |
1-164 |
Complete |
ISO |
5361 Fourth edition 2023-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
12/18/2023 |
Materials |
8-606 |
Complete |
ASTM |
F2537-23 |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
09/17/2018 |
Radiology |
12-319 |
Complete |
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 |
Complete |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
08/21/2017 |
Materials |
8-451 |
Complete |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
12/18/2023 |
Dental/ ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
06/27/2016 |
Radiology |
12-294 |
Complete |
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 |
09/17/2018 |
InVitro Diagnostics |
7-283 |
Complete |
CLSI |
POCT04 3rd Edition |
Essential Tools for Implementation and Management of a Point-of-Care Testing Program |
09/17/2018 |
InVitro Diagnostics |
7-275 |
Complete |
CLSI |
EP07 3rd Edition |
Interference Testing in Clinical Chemistry. |
09/17/2018 |
InVitro Diagnostics |
7-276 |
Complete |
CLSI |
M38 3rd Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi |
09/17/2018 |
Orthopedic |
11-337 |
Complete |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
12/18/2023 |
Sterility |
14-595 |
Complete |
ISO |
11607-2 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]. |
12/18/2023 |
Sterility |
14-596 |
Complete |
ASTM |
F88/F88M-23 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
08/21/2017 |
Orthopedic |
11-280 |
Complete |
ASTM |
F2624-12 (Reapproved 2020) |
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
12/18/2023 |
Dental/ ENT |
4-312 |
Complete |
ANSI ASA |
S3.35-2021 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
06/07/2018 |
Physical Medicine |
16-201 |
Complete |
ISO |
7176-19 Second Edition 2008-07-15 |
Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] |
09/17/2018 |
Orthopedic |
11-334 |
Complete |
ASTM |
F1829-17 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
07/09/2014 |
Dental/ ENT |
4-160 |
Complete |
ANSI ASA |
S3.1-1999 (Reaffirmed 2023) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
09/17/2018 |
Orthopedic |
11-335 |
Complete |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
08/14/2015 |
Dental/ ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
08/14/2015 |
Dental/ ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2019) |
American National Standard For an Occluded Ear Simulator |
09/09/2008 |
Dental/ ENT |
4-145 |
Complete |
ISO |
22803 First edition 2004-09-01 |
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
08/14/2015 |
Ophthalmic |
10-98 |
Complete |
ISO |
11979-2 Second edition 2014-08-15 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
08/14/2015 |
Ophthalmic |
10-97 |
Complete |
ISO |
13212 Third edition 2014-09-01 |
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |
07/06/2020 |
Nanotechnology |
18-15 |
Complete |
ASTM |
E3025-16 |
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
07/06/2020 |
Materials |
8-531 |
Complete |
ASTM |
F3321-19 |
Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
07/15/2019 |
General I (QS/ RM) |
5-123 |
Complete |
ISO |
80369-3 First Edition 2016-07-01 |
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. |
12/21/2020 |
Dental/ ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
08/14/2015 |
Anesthesiology |
1-105 |
Complete |
ISO |
80601-2-72 First edition 2015-04-11 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-402 |
Complete |
ASTM |
F1670/F1670M-17 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
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 |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-128 |
Complete |
ISO CIE |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
07/09/2014 |
Radiology |
12-279 |
Complete |
IEC |
62127-03 Edition 1.1 2013-05 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
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 |
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 |
04/04/2016 |
Materials |
8-135 |
Complete |
ASTM |
F2392-04 (Reapproved 2015) |
Standard Test Method for Burst Strength of Surgical Sealants |
09/17/2018 |
Physical Medicine |
16-203 |
Complete |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
01/27/2015 |
Dental/ ENT |
4-218 |
Complete |
ISO |
27020 First edition 2010-12-15 |
Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA |
Standard No.100-2012 |
Orthodontic Brackets and Tubes |
12/23/2019 |
Radiology |
12-329 |
Complete |
IEC |
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
05/29/2023 |
Biocompatibility |
2-301 |
Complete |
ASTM |
F1983-23 |
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
01/30/2014 |
Neurology |
17-12 |
Complete |
ISO |
7197 Third edition 2006-06-01 |
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
01/30/2014 |
General I (QS/ RM) |
5-84 |
Complete |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
07/26/2016 |
Biocompatibility |
2-227 |
Complete |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
05/29/2023 |
Radiology |
12-347 |
Complete |
IEC |
60601-2-33 Edition 4.0 2022-08 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
09/17/2018 |
Dental/ ENT |
4-247 |
Complete |
ISO |
28319 Second edition 2018-04 |
Dentistry - Laser welding and filler materials |
ANSI ADA |
Standard No. 84-2020 |
Laser Welding and Filler Materials in Dentistry |
04/04/2016 |
Orthopedic |
11-304 |
Complete |
ASTM |
F3107-14 |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
04/04/2016 |
Materials |
8-114 |
Complete |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
04/04/2016 |
Materials |
8-116 |
Complete |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
01/27/2015 |
Orthopedic |
11-283 |
Complete |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-306 |
Complete |
ASTM |
F1671/F1671M-13 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-321 |
Complete |
IEC |
60601-2-52 Edition 1.0 2009-12 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
09/17/2018 |
Sterility |
14-512 |
Complete |
ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
09/17/2018 |
Cardiovascular |
3-156 |
Complete |
ISO |
14708-1 Second edition 2014-08-15 |
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ANSI AAMI ISO |
14708-1:2014 |
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
09/17/2018 |
Cardiovascular |
3-154 |
Complete |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
09/17/2018 |
Sterility |
14-294 |
Complete |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
09/17/2018 |
Sterility |
14-517 |
Complete |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
09/17/2018 |
Sterility |
14-513 |
Complete |
ASTM |
F2825-18 |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery |
09/17/2018 |
Radiology |
12-318 |
Complete |
IEC |
60601-2-64 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
09/17/2018 |
Radiology |
12-320 |
Complete |
IEC |
62667 Edition 1.0 2017-08 |
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
08/21/2017 |
Dental/ ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
08/21/2017 |
Materials |
8-226 |
Complete |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
08/21/2017 |
Materials |
8-459 |
Complete |
SAE |
AMS2750 Rev. E 2012-07 |
Pyrometry |
08/21/2017 |
Biocompatibility |
2-155 |
Complete |
ASTM |
F2147-01 (Reapproved 2016) |
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
09/09/2008 |
InVitro Diagnostics |
7-163 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
03/16/2012 |
Radiology |
12-143 |
Complete |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
01/15/2013 |
Sterility |
14-359 |
Complete |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
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 |
08/21/2017 |
General II (ES/ EMC) |
19-22 |
Complete |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
03/16/2012 |
Cardiovascular |
3-96 |
Complete |
ISO |
81060-1 First edition 2007-12-01 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
ANSI AAMI ISO |
81060-1:2007/(R)2013 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
07/12/1999 |
Radiology |
12-51 |
Complete |
IEC |
61145 (1992-05) |
Calibration and usage of ionization chamber systems for assay of radionuclides |
03/08/2004 |
InVitro Diagnostics |
7-86 |
Complete |
CLSI |
C29-A2 (Replaces C29-A) |
Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition |
03/08/2004 |
InVitro Diagnostics |
7-87 |
Complete |
CLSI |
C31-A2 (Replaces C31-A) |
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition. |
03/08/2004 |
InVitro Diagnostics |
7-88 |
Complete |
CLSI |
C37-A |
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
03/08/2004 |
InVitro Diagnostics |
7-89 |
Complete |
CLSI |
C39-A (Replaces C39-P) |
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
10/04/2004 |
InVitro Diagnostics |
7-105 |
Complete |
CLSI |
H30-A2 |
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
08/21/2017 |
Sterility |
14-502 |
Complete |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |