|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/23/2016 |
Materials |
8-439 |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
12/23/2016 |
Materials |
8-440 |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
12/23/2016 |
Materials |
8-441 |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
12/23/2016 |
Materials |
8-442 |
ASTM |
F3127-16 |
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
12/23/2016 |
Materials |
8-444 |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
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 |
12/23/2016 |
Orthopedic |
11-312 |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
12/23/2016 |
Orthopedic |
11-314 |
ISO |
14242-2 Second edition 2016-09-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement |
12/23/2016 |
Orthopedic |
11-316 |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
12/23/2016 |
Orthopedic |
11-317 |
ASTM |
F3129-16 |
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
12/23/2016 |
Orthopedic |
11-319 |
ISO |
7206-12 First edition 2016-10-01 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
12/23/2016 |
Orthopedic |
11-320 |
ISO |
7206-13 First edition 2016-07-01 |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components |
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 |
12/23/2016 |
Radiology |
12-303 |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
12/23/2016 |
Radiology |
12-304 |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
12/23/2016 |
Software/ Informatics |
13-85 |
CLSI |
AUTO11-A2 |
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
12/23/2016 |
Software/ Informatics |
13-86 |
IEC ISO |
15026-1 First edition 2013-11-01 |
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
12/23/2016 |
Software/ Informatics |
13-87 |
IEC ISO |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
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 |
12/23/2016 |
Sterility |
14-496 |
ASTM |
F1608-16 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
12/23/2016 |
Sterility |
14-497 |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
12/23/2016 |
Sterility |
14-499 |
ASTM |
D4169-16 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
12/23/2016 |
Sterility |
14-500 |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
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) |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-379 |
ISO |
7864 Fourth edition 2016-08-01 |
Sterile hypodermic needles for single use - Requirements and test methods |
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 |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-381 |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
09/21/2016 |
General Plastic Surgery/ General Hospital |
6-382 |
ISO |
11608-7 First edition 2016-08-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
09/21/2016 |
InVitro Diagnostics |
7-265 |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
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 |
09/21/2016 |
Ophthalmic |
10-101 |
ISO |
18189 First edition 2016-06-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
07/26/2016 |
Biocompatibility |
2-169 |
ANSI AAMI ISO |
10993-13:2010/(R)2014 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
ISO |
10993-13 Second edition 2010-06-15 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
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 |
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 |
07/26/2016 |
Biocompatibility |
2-191 |
ANSI AAMI ISO |
10993-12:2012 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
ISO |
10993-12 Fourth edition 2012-07-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
07/26/2016 |
Biocompatibility |
2-213 |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
07/26/2016 |
Biocompatibility |
2-222 |
ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
07/26/2016 |
Biocompatibility |
2-227 |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
07/26/2016 |
Biocompatibility |
2-228 |
ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
07/26/2016 |
Biocompatibility |
2-237 |
ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
07/26/2016 |
Biocompatibility |
2-240 |
ANSI AAMI ISO |
TIR 10993-20:2006 |
Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
ISO |
/TS 10993-20 First edition 2006-08-01 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
07/26/2016 |
Biocompatibility |
2-241 |
ANSI AAMI ISO |
/TR 37137:2014 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |
ISO |
/TR 37137 First edition 2014-05-15 |
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |
07/26/2016 |
Biocompatibility |
2-243 |
ISO |
/TR 10993-33 First Edition 2015-03-01 |
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 |
06/27/2016 |
Cardiovascular |
3-143 |
ISO |
12417 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products |
06/27/2016 |
Dental/ ENT |
4-86 |
ANSI ADA |
Standard No. 38-2000 (R2015) |
Metal-Ceramic Dental Restorative Systems |
06/27/2016 |
Dental/ ENT |
4-139 |
ANSI ADA |
Standard No. 48-2004 (R2015) |
Visible Light Curing Units |
06/27/2016 |
Dental/ ENT |
4-202 |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
06/27/2016 |
Dental/ ENT |
4-227 |
ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
06/27/2016 |
Dental/ ENT |
4-228 |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
06/27/2016 |
General I (QS/ RM) |
5-57 |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
06/27/2016 |
General I (QS/ RM) |
5-89 |
IEC |
60601-1-6 Edition 3.1 2013-10 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
06/27/2016 |
General I (QS/ RM) |
5-108 |
ISO |
80369-6 First Edition 2016-03-15 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
06/27/2016 |
General II (ES/ EMC) |
19-14 |
IEC |
60601-1-11 Edition 2.0 2015-01 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
06/27/2016 |
General II (ES/ EMC) |
19-15 |
ANSI AAMI IEC |
60601-1-12:2016 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency |
IEC |
60601-1-12 Edition 1.0 2014-06 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-363 |
ISO |
11810 Second edition 2015-12-15 |
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-364 |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-377 |
ISO |
11608-5 First edition 2012-10-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function. |
06/27/2016 |
InVitro Diagnostics |
7-264 |
CLSI |
MM21-1st Edition (Reaffirmed: January 2020) |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
06/27/2016 |
Materials |
8-217 |
ASTM |
F620-11 (Reapproved 2015) |
Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
06/27/2016 |
Materials |
8-421 |
ASTM |
F629-15 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
06/27/2016 |
Materials |
8-426 |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
06/27/2016 |
Materials |
8-427 |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
06/27/2016 |
Materials |
8-429 |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
06/27/2016 |
Materials |
8-430 |
ISO |
13356:2015 Third Edition 2015-09-15 |
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
06/27/2016 |
Materials |
8-431 |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
06/27/2016 |
Materials |
8-432 |
ASTM ISO |
52921 First Edition 2013-06-01 |
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. |
06/27/2016 |
Materials |
8-434 |
ASTM ISO |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
06/27/2016 |
Orthopedic |
11-306 |
ASTM |
F1814-15 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
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 |
06/27/2016 |
Orthopedic |
11-308 |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
06/27/2016 |
Radiology |
12-293 |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
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 |
06/27/2016 |
Radiology |
12-295 |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
06/27/2016 |
Radiology |
12-297 |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
06/27/2016 |
Radiology |
12-298 |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
06/27/2016 |
Radiology |
12-301 |
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 |
06/27/2016 |
Radiology |
12-302 |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
06/27/2016 |
Software/ Informatics |
13-82 |
ANSI AAMI ISO |
TIR 80001-2-6:2014 |
Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
06/27/2016 |
Software/ Informatics |
13-83 |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
06/27/2016 |
Software/ Informatics |
13-84 |
IEEE ISO |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
06/27/2016 |
Sterility |
14-481 |
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 |
14-482 |
ASTM |
F88/F88M-15 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
06/27/2016 |
Sterility |
14-483 |
ASTM ISO |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
06/15/2016 |
Cardiovascular |
3-132 |
ANSI AAMI ISO |
27185:2012 |
Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements |
ISO |
27185 First edition 2012-02-15 |
Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements |
06/15/2016 |
General I (QS/ RM) |
5-102 |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
06/15/2016 |
General I (QS/ RM) |
5-104 |
IEC |
/TR 60878 Ed. 3.0 b:2015 |
Graphical symbols for electrical equipment in medical practice |
04/04/2016 |
Anesthesiology |
1-106 |
ISO |
17510 First Edition 2015-08-01 |
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
04/04/2016 |
Anesthesiology |
1-115 |
ISO |
80601-2-70 First Edition 2015-01-15 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
04/04/2016 |
Cardiovascular |
3-125 |
ANSI AAMI ISO |
5841-3:2013 |
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
ISO |
5841-3 Third edition 2013-04-15 |
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers |
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 |
04/04/2016 |
Dental/ ENT |
4-221 |
ISO |
7494-2 Second edition 2015-04-01 |
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
04/04/2016 |
Dental/ ENT |
4-222 |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
04/04/2016 |
Dental/ ENT |
4-224 |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
04/04/2016 |
General I (QS/ RM) |
5-98 |
ANSI ESD |
S20.20-2014 |
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) |
04/04/2016 |
General I (QS/ RM) |
5-99 |
ASTM |
D4332-14 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
04/04/2016 |
General II (ES/ EMC) |
19-16 |
ANSI AAMI |
HA60601-1-11:2015 |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) |
04/04/2016 |
General II (ES/ EMC) |
19-17 |
ANSI IEEE |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
ASTM |
D3772-15 |
Standard Specification for Industrial Rubber Finger Cots |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-356 |
ASTM |
D5712-15 |
Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-357 |
ISO |
10555-6 First edition 2015-04-15 |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports |