|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 10/04/2004 |
Radiology |
12-116 |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
| 09/08/2009 |
Software/
Informatics |
13-29 |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
| 05/05/2010 |
InVitro Diagnostics |
7-207 |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
| 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 |
InVitro Diagnostics |
7-227 |
CLSI |
M53-A (Replaces M53-P) |
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| 01/30/2014 |
Dental/
ENT |
4-153 |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 01/30/2014 |
Orthopedic |
11-267 |
ASTM |
F2009-00 (Reapproved 2011) |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 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 |
InVitro Diagnostics |
7-264 |
CLSI |
MM21-1st Edition |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-214 |
ASTM |
D6355-07 (Reapproved 2017) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| 08/06/2013 |
Physical Medicine |
16-192 |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-294 |
ISO |
11608-3 Second edition 2012-10-01 |
Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers |
| 06/27/2016 |
Radiology |
12-299 |
IEC |
62563-1 Edition 1.1 |
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
| 01/27/2015 |
Sterility |
14-456 |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO |
/TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 07/26/2016 |
Biocompatibility |
2-119 |
ASTM |
F813-07 (Reapproved 2012) |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| 06/07/2018 |
Radiology |
12-311 |
IEC |
60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
| 09/21/2016 |
InVitro Diagnostics |
7-265 |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
| 01/27/2015 |
Software/
Informatics |
13-71 |
RII |
Version 2.48 |
Logical Observation Identifiers Names and Codes (LOINC) |
| 12/23/2016 |
Materials |
8-442 |
ASTM |
F3127-16 |
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| 08/21/2017 |
Biocompatibility |
2-155 |
ASTM |
F2147-01 (Reapproved 2016) |
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
| 06/07/2018 |
Anesthesiology |
1-132 |
ISO |
10079-2 Third Edition 2014-05-01 |
Medical suction equipment - Part 2: Manually powered suction equipment |
| 04/04/2016 |
Physical Medicine |
16-197 |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| 04/04/2016 |
Materials |
8-404 |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 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 |
| 06/07/2018 |
Nanotechnology |
18-9 |
ISO |
/TR 13014 First edition 2012-05-15 |
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. |
| 09/17/2018 |
Materials |
8-479 |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
| 09/17/2018 |
Orthopedic |
11-326 |
ASTM |
F384-17 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| 09/17/2018 |
Materials |
8-468 |
ASTM |
F2459-18 |
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| 09/17/2018 |
InVitro Diagnostics |
7-283 |
CLSI |
POCT04 3rd Edition |
Essential Tools for Implementation and Management of a Point-of-Care Testing Program |
| 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 |
| 06/07/2018 |
Anesthesiology |
1-134 |
ISO |
18562-1 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-380 |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 07/09/2014 |
Dental/
ENT |
4-149 |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
| 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 |
| 06/07/2018 |
Biocompatibility |
2-250 |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
| 04/04/2016 |
Nanotechnology |
18-1 |
ASTM |
E2490-09 (Reapproved 2015) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) |
| 01/14/2019 |
Neurology |
17-14 |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-123 |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 09/17/2018 |
Sterility |
14-516 |
ASTM |
F3039-15 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| 08/21/2017 |
Orthopedic |
11-242 |
ASTM |
F1839-08 (Reapproved 2016) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 01/30/2014 |
Materials |
8-218 |
ASTM |
F799-11 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
| 06/27/2016 |
Materials |
8-425 |
ASTM |
F2820-12 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 04/04/2016 |
Orthopedic |
11-247 |
ASTM |
F2789-10 (Reapproved 2015) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 03/16/2012 |
Sterility |
14-354 |
ANSI AAMI ISO |
18472:2006/(R)2010 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
| ISO |
18472 First edition 2006-06-01 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
| 06/27/2016 |
Orthopedic |
11-307 |
ASTM |
F2385-15 (Reapproved 2019) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
| 08/21/2017 |
Materials |
8-455 |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 01/14/2019 |
Software/
Informatics |
13-106 |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
| 04/04/2016 |
Materials |
8-403 |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
| 01/14/2019 |
InVitro Diagnostics |
7-286 |
CLSI |
M11 9th Edition |
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| 07/09/2014 |
Dental/
ENT |
4-212 |
ISO |
7405 Second edition 2008-12-15 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)] |
| 12/23/2019 |
Materials |
8-500 |
ISO |
5832-12 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
| 01/14/2019 |
Nanotechnology |
18-5 |
ASTM |
E2859-11 (Reapproved 2017) |
Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy |
| 08/21/2017 |
Dental/
ENT |
4-232 |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 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 |
| 07/15/2019 |
Materials |
8-496 |
ISO |
5834-4 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method |
| 07/09/2014 |
Sterility |
14-257 |
ASTM |
D3078-02 (Reapproved 2013) |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
| 07/09/2014 |
General II (ES/
EMC) |
19-9 |
IEC |
60601-1-10 Edition 1.1 2013-11 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
| 04/04/2016 |
Tissue Engineering |
15-24 |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
| 09/17/2018 |
Ophthalmic |
10-56 |
ANSI |
Z80.12-2007 (R2017) |
American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
| 12/04/2017 |
Software/
Informatics |
13-99 |
IEC ISO |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| 12/23/2016 |
Biocompatibility |
2-94 |
ASTM |
F981-04 (Reapproved 2016) |
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| 01/30/2014 |
Biocompatibility |
2-205 |
ANSI AAMI ISO |
14155:2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)] |
| ISO |
14155 Second edition 2011-02-01 |
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)] |
| 01/14/2019 |
InVitro Diagnostics |
7-262 |
CLSI |
M45 3rd Edition |
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria. |
| 07/06/2020 |
Materials |
8-532 |
ASTM |
F3335-20 |
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion |
| 12/23/2019 |
Materials |
8-522 |
ASTM |
F2129-19a |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| 07/09/2014 |
Tissue Engineering |
15-39 |
ASTM |
F2150-13 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products |
| 01/30/2014 |
Dental/
ENT |
4-201 |
ISO |
9693-1 First edition 2012-02-15 |
Dentistry -- Compatibility testing - Part 1: Metal-ceramic systems |
| 04/04/2016 |
Anesthesiology |
1-115 |
ISO |
80601-2-70 First Edition 2015-01-15 |
Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment |
| 08/21/2017 |
Tissue Engineering |
15-50 |
ASTM |
F2739-16 |
Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds |
| 12/23/2016 |
General Plastic Surgery/
General Hospital |
6-165 |
ASTM |
D6977-04 (Reapproved 2016) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
| 07/06/2020 |
Orthopedic |
11-368 |
ASTM |
F3334-19 |
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| 01/14/2019 |
Cardiovascular |
3-142 |
ISO |
/TS 17137 First edition 2014-05-15 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. |
| 07/06/2020 |
Biocompatibility |
2-276 |
ISO |
10993-18 Second edition 2020-01 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process. |
| 01/15/2013 |
Sterility |
14-313 |
ASTM |
F2475-11 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| 07/15/2019 |
Biocompatibility |
2-263 |
ASTM |
F1903-18 |
Standard Practice for Testing for Cellular Responses to Particles in vitro |
| 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 |
| 07/26/2016 |
Biocompatibility |
2-238 |
ANSI AAMI |
BE83:2006/(R)2011 |
Biological evaluation of medical devices - Part 18: Chemical characterization of materials |
| 07/06/2020 |
Sterility |
14-542 |
ASTM ISO |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 08/14/2015 |
Materials |
8-391 |
ASTM |
F2313-10 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide |
| 12/23/2019 |
Materials |
8-508 |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 08/06/2013 |
Software/
Informatics |
13-47 |
IEEE ISO |
11073-10101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature |
| 07/06/2020 |
InVitro Diagnostics |
7-298 |
CLSI |
EP35, 1st Edition |
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-254 |
ASTM |
F2100-11 (Reapproved 2018) |
Standard Specification for Performance of Materials Used in Medical Face Masks |
| 08/06/2013 |
Software/
Informatics |
13-56 |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
| 04/04/2016 |
Software/
Informatics |
13-81 |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 08/06/2013 |
Software/
Informatics |
13-49 |
IEEE ISO |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| 03/14/2011 |
Radiology |
12-226 |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| 01/14/2019 |
Anesthesiology |
1-138 |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 04/04/2016 |
Materials |
8-411 |
ASTM |
F2579-10 |
Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 07/15/2019 |
Materials |
8-493 |
ISO |
13779-2 Third edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite |
| 07/06/2020 |
Cardiovascular |
3-167 |
ISO |
/TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
| 12/23/2019 |
Software/
Informatics |
13-112 |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
| 01/14/2019 |
Cardiovascular |
3-44 |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
| 12/23/2019 |
Materials |
8-491 |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| 07/06/2020 |
Materials |
8-526 |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 07/15/2019 |
Orthopedic |
11-356 |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| 07/15/2019 |
Materials |
8-497 |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
ASTM |
D7103-19 |
Standard Guide for Assessment of Medical Gloves |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-176 |
ASTM |
D7103-06 (Reapproved 2013) |
Standard Guide for Assessment of Medical Gloves |
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