|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
08/21/2017 |
Materials |
8-451 |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
07/09/2014 |
Radiology |
12-272 |
IEC |
60601-2-17 Edition 3.0 2013-11 |
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
01/30/2014 |
Radiology |
12-266 |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
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 |
12/21/2020 |
Materials |
8-549 |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
12/21/2020 |
General I (QS/ RM) |
5-133 |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
04/04/2016 |
Orthopedic |
11-304 |
ASTM |
F3107-14 |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
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 |
04/04/2016 |
Materials |
8-114 |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
08/21/2017 |
Materials |
8-452 |
ASTM |
F1635-16 |
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
01/30/2014 |
Sterility |
14-402 |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
01/30/2014 |
Sterility |
14-404 |
ASTM |
F2250-13 (Reapproved 2018) |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials |
01/30/2014 |
Sterility |
14-405 |
ASTM |
F2252/F2252M-13 (Reapproved 2018) |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape |
01/30/2014 |
Sterility |
14-406 |
ANSI AAMI |
ST8:2013/(R)2018 |
Hospital steam sterilizers |
08/14/2015 |
Ophthalmic |
10-99 |
ISO |
4311 First edition 1979-06-01 |
Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring |
08/14/2015 |
Physical Medicine |
16-194 |
ISO |
7176-25 First edition 2013-07-15 |
Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs |
08/21/2017 |
General Plastic Surgery/ General Hospital |
6-387 |
ANSI AAMI IEC |
60601-2-50:2009/A1:2016 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
IEC |
60601-2-50 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
10/19/2020 |
Software/ Informatics |
13-116 |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
12/21/2020 |
Orthopedic |
11-375 |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
09/09/2008 |
Dental/ ENT |
4-145 |
ISO |
22803 First edition 2004-09-01 |
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
04/04/2016 |
Dental/ ENT |
4-224 |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
08/14/2015 |
Ophthalmic |
10-98 |
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 |
ISO |
13212 Third edition 2014-09-01 |
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |
09/17/2018 |
Biocompatibility |
2-256 |
ASTM |
F720-17 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
09/17/2018 |
Materials |
8-465 |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
09/17/2018 |
Materials |
8-112 |
ASTM |
F1044-05 (Reapproved 2017)e1 |
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
09/17/2018 |
Materials |
8-466 |
ASTM |
F2213-17 |
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
06/07/2018 |
Software/ Informatics |
13-104 |
ANSI UL |
2900-2-1 First Edition 2017 |
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
06/07/2021 |
Anesthesiology |
1-151 |
ISO |
80601-2-70 Second edition 2020-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
08/21/2017 |
Materials |
8-195 |
ASTM |
F2024-10 (Reapproved 2016) |
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
08/21/2017 |
Materials |
8-428 |
ASTM |
F1581-08 (Reapproved 2020) |
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
01/14/2019 |
Materials |
8-483 |
ASTM |
F601-18 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
09/17/2018 |
Materials |
8-470 |
ASTM |
F2102-17 |
Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
06/07/2018 |
Physical Medicine |
16-201 |
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)] |
06/07/2018 |
Tissue Engineering |
15-51 |
ASTM |
F2347-15 |
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
06/07/2018 |
Tissue Engineering |
15-52 |
ASTM |
F2064-17 |
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
08/06/2013 |
Dental/ ENT |
4-204 |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) |
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
01/27/2015 |
Dental/ ENT |
4-185 |
ANSI ASA |
S3.45-2009 (Reaffirmed 2019) |
American National Standard Procedures for Testing Basic Vestibular Function |
07/09/2014 |
Dental/ ENT |
4-211 |
ANSI ASA |
S3.46-2013 (Reaffirmed 2018) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
09/17/2018 |
Orthopedic |
11-326 |
ASTM |
F384-17 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-425 |
ASTM |
F2100-19 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-341 |
ISO |
11608-1 Third edition 2014-12-15 |
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
06/07/2018 |
Ophthalmic |
10-110 |
ISO |
15798 Third edition 2013-09-15 |
Ophthalmic implants - Ophthalmic viscosurgical devices [Including: Amendment 1 (2017)] |
06/27/2016 |
Sterility |
14-482 |
ASTM |
F88/F88M-15 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-86 |
ISO |
16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
01/30/2014 |
Radiology |
12-259 |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
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. |
04/04/2016 |
Radiology |
12-196 |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
08/14/2015 |
Software/ Informatics |
13-75 |
IEEE ISO |
11073-10102 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG |
01/27/2015 |
General I (QS/ RM) |
5-48 |
ANSI |
Z1.9-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
06/07/2018 |
Anesthesiology |
1-130 |
ISO |
18082 First edition 2014-06-15 |
Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)] |
12/20/2021 |
Cardiovascular |
3-175 |
ISO |
5840-2 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
12/20/2021 |
Materials |
8-575 |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
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 |
08/21/2017 |
Anesthesiology |
1-124 |
ISO |
8835-7 First edition 2011-11-01 |
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
12/23/2016 |
Cardiovascular |
3-144 |
ISO |
7198 Second edition 2016-08-01 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
08/14/2015 |
General Plastic Surgery/ General Hospital |
6-110 |
ASTM |
F1441-03 (Reapproved 2014) |
Standard Specification for Soft-Tissue Expander Devices |
08/06/2013 |
Cardiovascular |
3-115 |
IEC |
60601-2-34 Edition 3.0 2011-05 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
07/09/2014 |
Radiology |
12-279 |
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 |
CLSI |
EP05-A3 (Reaffirmed: September 2019) |
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
12/19/2022 |
Dental/ ENT |
4-294 |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
05/30/2022 |
Sterility |
14-577 |
ANSI AAMI ISO |
11737-1:2018 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
09/17/2018 |
Physical Medicine |
16-203 |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
09/17/2018 |
Cardiovascular |
3-156 |
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 |
09/17/2018 |
Cardiovascular |
3-154 |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
09/17/2018 |
Sterility |
14-294 |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
01/27/2015 |
General I (QS/ RM) |
5-62 |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
04/04/2016 |
Materials |
8-415 |
ASTM |
F2778-09 (Reapproved 2020) |
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) |
08/14/2015 |
General I (QS/ RM) |
5-97 |
ANSI AAMI ISO |
|
Standard |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
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 |
08/14/2015 |
ObGyn/ Gastroenterology/ Urology |
9-108 |
ISO |
8009 Second edition 2014-11-15 |
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
08/14/2015 |
Ophthalmic |
10-95 |
ISO |
11979-6 Third edition 2014-10-01 |
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
08/21/2017 |
Materials |
8-455 |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
01/30/2014 |
General I (QS/ RM) |
5-84 |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
01/25/2013 |
Cardiovascular |
3-89 |
ANSI AAMI ISO |
27186:2010 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
ISO |
27186 First edition 2010-03-15 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
08/20/2012 |
Cardiovascular |
3-103 |
ANSI AAMI ISO |
25539-3:2011 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
ISO |
25539-3 First edition 2011-12-01 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
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 |
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 |
06/07/2018 |
Materials |
8-337 |
ASTM |
F621-12 (Reapproved 2017) |
Standard Specification for Stainless Steel Forgings for Surgical Implants |
06/07/2018 |
Materials |
8-356 |
ASTM |
F67-13 (Reapproved 2017) |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
12/19/2022 |
Sterility |
14-582 |
AAMI ISO |
TIR11137-4:2022 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
ISO |
TS 11137-4 First edition 2020-06 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
08/06/2013 |
Cardiovascular |
3-116 |
ANSI AAMI ISO |
25539-2:2012 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
ISO |
25539-2 Second edition 2012-12-01 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
12/19/2022 |
Software/ Informatics |
13-125 |
AAMI ANSI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
08/21/2017 |
InVitro Diagnostics |
7-273 |
CLSI |
M58 1st Edition |
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
08/21/2017 |
Software/ Informatics |
13-88 |
IEEE ISO |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
08/21/2017 |
Software/ Informatics |
13-93 |
IEEE |
Std 11073-10422-2016 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
08/21/2017 |
Materials |
8-453 |
ASTM |
F1295-16 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
08/21/2017 |
Dental/ ENT |
4-233 |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
09/17/2018 |
Sterility |
14-517 |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
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 |
Orthopedic |
11-247 |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
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 |
05/30/2022 |
ObGyn/ Gastroenterology/ Urology |
9-139 |
CIE ISO |
11664-5:2016 |
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
02/07/2022 |
General II (ES/ EMC) |
19-45 |
AIM |
Standard 7351731 Rev. 3.00 2021-06-04 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
08/21/2017 |
Software/ Informatics |
13-97 |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
01/14/2019 |
Anesthesiology |
1-120 |
ISO |
18190 First edition 2016-11-01 |
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
01/14/2019 |
General Plastic Surgery/ General Hospital |
6-338 |
ASTM |
D7866-14 |
Standard Specification for Radiation Attenuating Protective Gloves |