|
|
|
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)
|
| 12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
| 10/04/2010 |
Radiology |
12-213 |
Complete |
IEC |
62220-1-2 Edition 1.0 2007-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 10/04/2010 |
Radiology |
12-214 |
Complete |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| 07/09/2014 |
Radiology |
12-280 |
Complete |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
| 07/15/2019 |
Orthopedic |
11-351 |
Complete |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 12/23/2019 |
Software/
Informatics |
13-112 |
Complete |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
| 06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| 08/21/2017 |
Cardiovascular |
3-149 |
Complete |
ISO |
25539-1 Second edition 2017-02 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 07/15/2019 |
Materials |
8-513 |
Complete |
ISO |
20160 First edition 2006-05-01 |
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 12/21/2020 |
Ophthalmic |
10-121 |
Complete |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
| 07/15/2019 |
Orthopedic |
11-349 |
Complete |
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)] |
| 07/15/2019 |
Physical Medicine |
16-206 |
Complete |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
| 07/15/2019 |
Orthopedic |
11-353 |
Complete |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| 07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 07/06/2020 |
Anesthesiology |
1-146 |
Complete |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 06/07/2021 |
Orthopedic |
11-384 |
Complete |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
Complete |
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 |
| 12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 01/14/2019 |
Dental/
ENT |
4-250 |
Complete |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-251 |
Complete |
ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| 01/14/2019 |
Dental/
ENT |
4-252 |
Complete |
ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| 01/14/2019 |
Dental/
ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 12/23/2019 |
InVitro Diagnostics |
7-293 |
Complete |
CLSI |
QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
A Quality Management System Model for Laboratory Services. |
| 07/15/2019 |
Materials |
8-518 |
Complete |
ASTM |
F3306-19 |
Standard Test Method for Ion Release Evaluation of Medical Implants |
| 12/23/2019 |
Sterility |
14-538 |
Complete |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |
| 07/15/2019 |
Ophthalmic |
10-117 |
Complete |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 07/15/2019 |
InVitro Diagnostics |
7-287 |
Complete |
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 |
| 07/15/2019 |
InVitro Diagnostics |
7-288 |
Complete |
CLSI |
M24 3rd Edition |
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
| 12/23/2019 |
Materials |
8-508 |
Complete |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 04/04/2016 |
Radiology |
12-195 |
Complete |
NEMA |
MS 6-2008 (R2014, R2020) |
Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging |
| 03/18/2009 |
InVitro Diagnostics |
7-180 |
Complete |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
| 08/20/2012 |
General Plastic Surgery/
General Hospital |
6-278 |
Complete |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 03/16/2012 |
Tissue Engineering |
15-31 |
Complete |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
| 01/15/2013 |
Sterility |
14-215 |
Complete |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
| 04/04/2016 |
Materials |
8-399 |
Complete |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| 01/27/2015 |
General I (QS/
RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
Complete |
ISO |
23908 First edition 2011-06-11 |
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 01/14/2019 |
Dental/
ENT |
4-163 |
Complete |
ANSI ASA |
S3.5-1997 (Reaffirmed 2020) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 07/06/2020 |
InVitro Diagnostics |
7-298 |
Complete |
CLSI |
EP35, 1st Edition |
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| 08/06/2013 |
Software/
Informatics |
13-52 |
Complete |
ISO IEEE |
11073-10408 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| 06/27/2016 |
Materials |
8-427 |
Complete |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| 12/23/2016 |
Physical Medicine |
16-199 |
Complete |
ISO |
7176-28 First edition 2012-10-1 |
Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |
| 08/21/2017 |
Materials |
8-458 |
Complete |
ASTM |
G5-14 |
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements |
| 06/27/2016 |
General I (QS/
RM) |
5-108 |
Complete |
ISO |
80369-6 First Edition 2016-03-15 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
| 12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
| 06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-214 |
Complete |
ASTM |
D6355-07(2022) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| 06/07/2018 |
Radiology |
12-313 |
Complete |
IEC |
TS 62462 Edition 2.0 2017-07 |
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems |
| 12/23/2019 |
Radiology |
12-327 |
Complete |
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 I (QS/
RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
| ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
Materials |
8-541 |
Complete |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/21/2020 |
Materials |
8-542 |
Complete |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 08/14/2015 |
Software/
Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| 04/04/2016 |
Software/
Informatics |
13-81 |
Complete |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 08/21/2017 |
Software/
Informatics |
13-91 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| 07/06/2020 |
Cardiovascular |
3-164 |
Complete |
ASTM |
F1830-19 |
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps |
| 03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 12/23/2016 |
Radiology |
12-303 |
Complete |
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 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| 09/09/2008 |
Software/
Informatics |
13-18 |
Complete |
CLSI |
LIS03-A |
Standard Guide for Selection of a Clinical Laboratory Information Management System |
| 12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| 03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
| 08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| 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)] |
| 08/06/2013 |
Software/
Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| 01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| 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 |
| 07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| 07/09/2014 |
Radiology |
12-281 |
Complete |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| 01/14/2019 |
Anesthesiology |
1-138 |
Complete |
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 |
| 07/09/2014 |
Radiology |
12-283 |
Complete |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
| 03/14/2011 |
Radiology |
12-226 |
Complete |
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 |
| 03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)] |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/21/2020 |
Tissue Engineering |
15-65 |
Complete |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| 09/17/2018 |
Orthopedic |
11-340 |
Complete |
ASTM |
F3018-17 |
Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
| 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 |
| 12/21/2020 |
Dental/
ENT |
4-267 |
Complete |
ISO |
21606 First edition 2007-06 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| ANSI ADA |
Standard No. 105-2010 (R2015) |
Orthodontic Elastomeric Materials |
| 12/21/2020 |
InVitro Diagnostics |
7-300 |
Complete |
CLSI |
MM13 2nd Edition |
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| 12/21/2020 |
InVitro Diagnostics |
7-301 |
Complete |
CLSI |
GP42 7th Edition |
Collection of Capillary Blood Specimens |
| 12/21/2020 |
InVitro Diagnostics |
7-302 |
Complete |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| 12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| 06/27/2016 |
Materials |
8-426 |
Complete |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-127 |
Complete |
ISO CIE |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-129 |
Complete |
ISO CIE |
61966-2-1 First edition 1999-10 |
Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] |
| 07/15/2019 |
Materials |
8-509 |
Complete |
ASTM |
F702-18 |
Standard Specification for Polysulfone Resin for Medical Applications |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-272 |
Complete |
ASTM |
F2062-00 (Reapproved 2018) |
Standard Specification for Square Drive Interconnections on Surgical Instruments |
| 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)] |
| 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 |
| 12/21/2020 |
Dental/
ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
| 01/14/2019 |
Software/
Informatics |
13-79 |
Complete |
IEC |
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
Medical device software - Software life cycle processes |
| ANSI AAMI IEC |
62304:2006/A1:2016 |
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
| 01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
| 04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
| 07/15/2019 |
Biocompatibility |
2-265 |
Complete |
ASTM |
F2901-19 |
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 08/06/2013 |
Dental/
ENT |
4-204 |
Complete |
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) |
| 12/23/2016 |
Software/
Informatics |
13-87 |
Complete |
ISO IEC |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
| 01/14/2019 |
Nanotechnology |
18-7 |
Complete |
ASTM |
E2834-12 (Reapproved 2022) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) |
| 12/23/2019 |
Orthopedic |
11-362 |
Complete |
ISO |
22622 First edition 2019-07 |
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-424 |
Complete |
ASTM |
D5151-19(2023) |
Standard Test Method for Detection of Holes in Medical Gloves |
| 08/21/2017 |
Software/
Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| 12/21/2020 |
Nanotechnology |
18-18 |
Complete |
ASTM |
E3247-20 |
Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-121 |
Complete |
IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
| ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| 12/23/2019 |
General I (QS/
RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 12/23/2019 |
Radiology |
12-328 |
Complete |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
| 01/14/2019 |
Radiology |
12-102 |
Complete |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
| 07/06/2020 |
Tissue Engineering |
15-61 |
Complete |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| 07/06/2020 |
Cardiovascular |
3-155 |
Complete |
IEC |
60601-2-47 Edition 2.0 2012-02 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
| ANSI AAMI IEC |
60601-2-47:2012/(R)2016 |
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| 08/06/2013 |
Software/
Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 12/23/2019 |
Materials |
8-521 |
Complete |
ASTM |
F2313-18 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
| 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)]. |
| 12/23/2019 |
Physical Medicine |
16-226 |
Complete |
RESNA ANSI |
WC-4:2017 Section 10 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers. |
| 12/23/2019 |
Physical Medicine |
16-228 |
Complete |
RESNA ANSI |
WC-4:2017 Section 19 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles. |
| 07/15/2019 |
Anesthesiology |
1-144 |
Complete |
ISO |
80601-2-80 First edition 2018-07 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
| 07/15/2019 |
Biocompatibility |
2-268 |
Complete |
ISO |
TS 21726 First edition 2019-02 |
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents |
| 12/23/2019 |
Dental/
ENT |
4-261 |
Complete |
ISO |
7405 Third edition 2018-10 Corrected version 2018-12 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 12/23/2019 |
Dental/
ENT |
4-262 |
Complete |
IEC |
80601-2-60 Edition 2.0 2019-06 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 07/09/2014 |
Software/
Informatics |
13-68 |
Complete |
ISO |
11073-90101 First edition 2008-01-15 |
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
| 07/15/2019 |
Materials |
8-510 |
Complete |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
| 09/09/2008 |
Radiology |
12-166 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
| 07/15/2019 |
Materials |
8-504 |
Complete |
ASTM |
F561-19 |
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-126 |
Complete |
ISO CIE |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
| 01/30/2014 |
InVitro Diagnostics |
7-239 |
Complete |
CLSI |
EP32-R (Formerly X05-R) |
Metrological Traceability and Its Implementation; A Report |
| 07/09/2014 |
Radiology |
12-272 |
Complete |
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 |
Complete |
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 |
| 01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-111 |
Complete |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
| 12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| 01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
| 09/17/2018 |
Materials |
8-478 |
Complete |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
| 04/04/2016 |
Materials |
8-404 |
Complete |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 04/04/2016 |
Materials |
8-406 |
Complete |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 04/04/2016 |
ObGyn/
Gastroenterology/
Urology |
9-110 |
Complete |
ISO |
8600-1 Fourth Edition 2015-10-15 |
Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
| 04/04/2016 |
InVitro Diagnostics |
7-260 |
Complete |
CLSI |
MM03-3rd Edition (Replaces MM03-A2) |
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
| 12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
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 |
| ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 06/07/2021 |
Dental/
ENT |
4-274 |
Complete |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 08/14/2015 |
Radiology |
12-290 |
Complete |
IEC |
61910-1 Edition 1.0 2014-09 |
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| 07/06/2020 |
Cardiovascular |
3-167 |
Complete |
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 |
| 06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| 07/15/2019 |
General II (ES/
EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
| 01/14/2019 |
Software/
Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
| 12/23/2019 |
Software/
Informatics |
13-111 |
Complete |
IEEE |
Std 11073-10201-2018 |
Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
| 06/07/2021 |
InVitro Diagnostics |
7-306 |
Complete |
CLSI |
EP06 2nd Edition |
Evaluation of the Linearity of Quantitative Measurement Procedures |
| 12/21/2020 |
Anesthesiology |
1-148 |
Complete |
ISO |
80601-2-69 Second edition 2020-11 |
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
| 07/06/2020 |
Software/
Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 07/06/2020 |
Sterility |
14-540 |
Complete |
ISO |
11737-2 Third edition 2019-12 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ANSI AAMI ISO |
11737-2:2019 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| 07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
| 07/15/2019 |
Anesthesiology |
1-116 |
Complete |
ISO |
5360 Fourth edition 2016-02-15 |
Anaesthetic vaporizers - Agent specific filling systems |
| 07/15/2019 |
Anesthesiology |
1-122 |
Complete |
ISO |
5364 Fifth edition 2016-09-01 |
Anaesthetic and respiratory equipment-Oropharyngeal airways |
| 12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
| 12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| 12/23/2019 |
Materials |
8-523 |
Complete |
ASTM |
F3275-19 |
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device |
| 12/23/2019 |
Materials |
8-524 |
Complete |
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 |
| 07/06/2020 |
Orthopedic |
11-363 |
Complete |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| 12/23/2019 |
Radiology |
12-309 |
Complete |
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 |
| 06/07/2021 |
Orthopedic |
11-379 |
Complete |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
| 06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
| 06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| 12/23/2019 |
General II (ES/
EMC) |
19-33 |
Complete |
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 |
Complete |
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) |
| 07/06/2020 |
Dental/
ENT |
4-263 |
Complete |
ISO |
9693 Third edition 2019-10 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA |
Standard No. 38-2020 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| 12/23/2019 |
General II (ES/
EMC) |
19-32 |
Complete |
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 |
| 01/14/2019 |
Ophthalmic |
10-114 |
Complete |
ANSI |
Z80.28-2017 |
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes |
| 04/04/2016 |
ObGyn/
Gastroenterology/
Urology |
9-113 |
Complete |
CEN |
EN 1618:1997 |
Catheters other than intravascular catheters - Test methods for common properties |
| 06/07/2021 |
Software/
Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
| 07/06/2020 |
Materials |
8-527 |
Complete |
ASTM |
F899-20 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| 12/21/2020 |
Biocompatibility |
2-280 |
Complete |
ASTM |
F1408-20a |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
| 07/06/2020 |
Orthopedic |
11-367 |
Complete |
ISO |
14243-3 Second edition 2014-11-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 07/06/2020 |
Sterility |
14-539 |
Complete |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| 07/06/2020 |
Materials |
8-529 |
Complete |
ASTM |
F2633-19 |
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
| 07/15/2019 |
Tissue Engineering |
15-57 |
Complete |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
| 07/15/2019 |
Tissue Engineering |
15-58 |
Complete |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| 01/14/2019 |
Software/
Informatics |
13-106 |
Complete |
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 |
| 01/14/2019 |
Software/
Informatics |
13-107 |
Complete |
ISO |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
| IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices |
| 07/15/2019 |
Sterility |
14-532 |
Complete |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| 12/23/2019 |
Physical Medicine |
16-219 |
Complete |
RESNA ANSI |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
| 10/19/2020 |
Software/
Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
| 07/15/2019 |
Biocompatibility |
2-264 |
Complete |
ASTM |
F2148-18 |
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). |
| 01/14/2019 |
Radiology |
12-321 |
Complete |
ANSI IES |
RP-27.3-17 |
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
| 06/07/2021 |
Anesthesiology |
1-151 |
Complete |
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 |
| 12/23/2019 |
Orthopedic |
11-360 |
Complete |
ASTM |
F1378-18e1 |
Standard Specification for Shoulder Prostheses |
| 01/14/2019 |
Radiology |
12-323 |
Complete |
ISO |
11990 Third edition 2018-08 |
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
| 01/14/2019 |
Radiology |
12-324 |
Complete |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
| 12/23/2019 |
Materials |
8-480 |
Complete |
ASTM |
F2063-18 |
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| 12/23/2019 |
Materials |
8-481 |
Complete |
ASTM |
F1314-18 |
Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
| 12/23/2019 |
Materials |
8-484 |
Complete |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-479 |
Complete |
ISO |
11608-5:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
| 05/30/2022 |
General II (ES/
EMC) |
19-47 |
Complete |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
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) [Including Amendment1 (2021)] |
| 07/26/2016 |
Biocompatibility |
2-170 |
Complete |
ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
| ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
| 01/14/2019 |
Physical Medicine |
16-204 |
Complete |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
| 07/06/2020 |
Orthopedic |
11-365 |
Complete |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| 12/19/2022 |
Anesthesiology |
1-160 |
Complete |
ISO |
80601-2-84 First edition 2020-07 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 05/30/2022 |
Sterility |
14-577 |
Complete |
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)] |
| 07/06/2020 |
Software/
Informatics |
13-113 |
Complete |
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 |
Complete |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-441 |
Complete |
ISO |
7886-3 Second edition 2020-05 |
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| 07/06/2020 |
Orthopedic |
11-364 |
Complete |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
| 03/16/2012 |
Anesthesiology |
1-72 |
Complete |
ISO |
10651-5 First edition 2006-02-01 |
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
| 08/06/2013 |
Ophthalmic |
10-78 |
Complete |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
| 01/27/2015 |
Sterility |
14-242 |
Complete |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 12/23/2019 |
General II (ES/
EMC) |
19-13 |
Complete |
IEC |
62133 Edition 2.0 2012-12 |
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 [Including: Corrigendum 1 (2013)] |
| 12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| 12/23/2019 |
Dental/
ENT |
4-260 |
Complete |
ANSI ASA |
S12.2-2019 |
American National Standard for Criteria for Evaluating Room Noise |
| 08/06/2013 |
Software/
Informatics |
13-56 |
Complete |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
| 03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
| 08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
| 12/23/2016 |
Materials |
8-368 |
Complete |
ASTM |
F2625-10 (Reapproved 2016) |
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
| 01/30/2014 |
Sterility |
14-395 |
Complete |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
| 01/30/2014 |
Sterility |
14-397 |
Complete |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
| 01/30/2014 |
Sterility |
14-398 |
Complete |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
| 01/30/2014 |
Sterility |
14-399 |
Complete |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
| 01/30/2014 |
Sterility |
14-400 |
Complete |
ASTM |
F2203-13 (Reapproved 2022) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
| 04/04/2016 |
Materials |
8-107 |
Complete |
ASTM |
F746-04 (Reapproved 2014) |
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials |
| 12/21/2020 |
Dental/
ENT |
4-268 |
Complete |
ISO |
15841 Second edition 2014-08 |
Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| ANSI ADA |
Standard No. 32-2017 |
Orthodontic Wires |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 12/20/2021 |
General II (ES/
EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-422 |
Complete |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
| 07/06/2020 |
Sterility |
14-543 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| 05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
| 12/20/2021 |
General II (ES/
EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
| 07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 01/14/2019 |
General I (QS/
RM) |
5-120 |
Complete |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| 01/14/2019 |
Dental/
ENT |
4-255 |
Complete |
ANSI ADA |
Standard No. 131-2015 (R2020) |
Dental CAD/CAM Machinable Zirconia Blanks |
| 12/19/2022 |
General I (QS/
RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 12/19/2022 |
General I (QS/
RM) |
5-141 |
Complete |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 12/23/2016 |
Materials |
8-441 |
Complete |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 01/14/2019 |
Nanotechnology |
18-5 |
Complete |
ASTM |
E2859-11 (Reapproved 2017) |
Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy |
| 12/23/2019 |
Materials |
8-519 |
Complete |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| 04/03/2023 |
General II (ES/
EMC) |
19-34 |
Complete |
IEC |
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section |
| 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 |
| 12/20/2021 |
Materials |
8-571 |
Complete |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 12/19/2022 |
Anesthesiology |
1-158 |
Complete |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
| 07/15/2019 |
Anesthesiology |
1-143 |
Complete |
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 |
| 07/15/2019 |
Orthopedic |
11-355 |
Complete |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
| 07/26/2016 |
Biocompatibility |
2-174 |
Complete |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| 01/14/2019 |
Orthopedic |
11-347 |
Complete |
ASTM |
F2077-18 |
Test Methods for Intervertebral Body Fusion Devices |
| 04/04/2016 |
Tissue Engineering |
15-24 |
Complete |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
| 05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| 05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 08/14/2015 |
Software/
Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
| 01/14/2019 |
Anesthesiology |
1-114 |
Complete |
ISO |
18835 First Edition 2015-04-01 |
Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
| 07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
| 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 |
| 07/15/2019 |
Ophthalmic |
10-118 |
Complete |
ANSI |
Z80.38-2017 (R2021) |
American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery |
| 07/15/2019 |
Dental/
ENT |
4-258 |
Complete |
ISO |
10139-2 Third edition 2016-06-15 |
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
| ANSI ADA |
Standard No. 160-2020 |
Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use |
| 07/06/2020 |
Radiology |
12-332 |
Complete |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-486 |
Complete |
ISO |
10535 Third edition 2021-10 |
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-253 |
Complete |
ISO |
10535 Second edition 2006-12-15 |
Hoists for the transfer of disabled persons - Requirements and test methods |
| 04/04/2016 |
General II (ES/
EMC) |
19-17 |
Complete |
IEEE ANSI |
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 |
| 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 |
| 01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| 01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| 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) |
| 09/17/2018 |
Sterility |
14-516 |
Complete |
ASTM |
F3039-15 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| 12/23/2016 |
General II (ES/
EMC) |
19-20 |
Complete |
IEEE ANSI |
C63.16-2016 (Revision of ANSI C63.16-1993) |
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment |
| 08/06/2013 |
Software/
Informatics |
13-59 |
Complete |
ISO IEC IEEE |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
| 12/04/2017 |
Software/
Informatics |
13-99 |
Complete |
ISO IEC |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| 12/18/2023 |
Sterility |
14-594 |
Complete |
ISO |
11607-1 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] |
| 04/04/2016 |
Dental/
ENT |
4-224 |
Complete |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
| 12/21/2020 |
Materials |
8-552 |
Complete |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 01/14/2019 |
InVitro Diagnostics |
7-178 |
Complete |
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 |
| 01/14/2019 |
InVitro Diagnostics |
7-232 |
Complete |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| 08/06/2013 |
Software/
Informatics |
13-38 |
Complete |
IEC |
80001-1 Edition 1.0 2010-10 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ANSI AAMI IEC |
80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| 03/18/2009 |
InVitro Diagnostics |
7-182 |
Complete |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-185 |
Complete |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
| 03/18/2009 |
General Plastic Surgery/
General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 03/18/2009 |
InVitro Diagnostics |
7-189 |
Complete |
CLSI |
M47-A (Replaces M47-P) |
Principles and Procedures for Blood Cultures; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-192 |
Complete |
CLSI |
MM18-A (Replaces MM18-P) |
Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline |
| 03/18/2009 |
InVitro Diagnostics |
7-71 |
Complete |
CLSI |
H15-A3 (Replaces H15-A2) |
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
| 03/18/2009 |
Software/
Informatics |
13-25 |
Complete |
CLSI |
AUTO8-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
| 03/18/2009 |
Software/
Informatics |
13-26 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| 08/21/2017 |
Software/
Informatics |
13-67 |
Complete |
ISO IEEE |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
| 12/23/2019 |
Materials |
8-501 |
Complete |
ISO |
5834-1 Fourth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
| 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 |
| 12/23/2019 |
Materials |
8-507 |
Complete |
ASTM |
F688-19 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 12/18/2023 |
Sterility |
14-596 |
Complete |
ASTM |
F88/F88M-23 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 07/26/2016 |
Biocompatibility |
2-222 |
Complete |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| 12/23/2019 |
Materials |
8-505 |
Complete |
ISO |
6474-2 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
| 08/20/2012 |
InVitro Diagnostics |
7-76 |
Complete |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
| 08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
| 08/20/2012 |
Anesthesiology |
1-87 |
Complete |
IEC |
60601-2-23 Edition 3.0 2011-02 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| 08/20/2012 |
InVitro Diagnostics |
7-197 |
Complete |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
| 07/09/2014 |
Dental/
ENT |
4-177 |
Complete |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
| 03/16/2012 |
InVitro Diagnostics |
7-150 |
Complete |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
| 01/14/2019 |
Tissue Engineering |
15-56 |
Complete |
ASTM |
F3224-17 |
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging |
| 08/21/2017 |
Biocompatibility |
2-246 |
Complete |
ASTM |
F1877-16 |
Standard Practice for Characterization of Particles |
| 01/30/2014 |
Software/
Informatics |
13-63 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
| IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-177 |
Complete |
ASTM |
E1112-00(2018) |
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-166 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
| 08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
| 08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-216 |
Complete |
ISO |
8536-7 Third edition 2009-01-15 |
Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
| 01/30/2014 |
Sterility |
14-402 |
Complete |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
| 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 |
| 09/17/2018 |
Ophthalmic |
10-57 |
Complete |
ANSI |
Z80.13-2007 (R2022) |
American National Standard for Ophthalmics - Phakic Intraocular Lenses |
| 09/17/2018 |
Ophthalmic |
10-111 |
Complete |
ISO |
11981 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
| 09/17/2018 |
Sterility |
14-293 |
Complete |
ANSI AAMI |
ST50:2004/(R)2018 |
Dry heat (heated air) sterilizers |
| 01/30/2014 |
Cardiovascular |
3-63 |
Complete |
ISO |
11318:2002 |
Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements. |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-240 |
Complete |
ISO |
8536-3 Third edition 2009-06-01 |
Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-276 |
Complete |
ISO |
8536-1 Fourth edition 2011-09-01 |
Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
| 08/06/2013 |
InVitro Diagnostics |
7-242 |
Complete |
CLSI |
C56-A |
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
| 06/27/2016 |
Materials |
8-430 |
Complete |
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 |
8-432 |
Complete |
ISO ASTM |
52921 First Edition 2013-06-01 |
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. |
| 06/27/2016 |
Materials |
8-434 |
Complete |
ISO ASTM |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
| 07/09/2014 |
Anesthesiology |
1-100 |
Complete |
CGA |
V-1:2013 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-380 |
Complete |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 12/23/2016 |
Software/
Informatics |
13-86 |
Complete |
ISO IEC |
15026-1 First edition 2013-11-01 |
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
| 10/09/2023 |
Software/
Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
| 01/14/2019 |
Biocompatibility |
2-136 |
Complete |
ASTM |
E1262-88 (Reapproved 2018) |
Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 01/14/2019 |
Biocompatibility |
2-145 |
Complete |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 04/04/2016 |
Orthopedic |
11-303 |
Complete |
ASTM |
F3047M-15 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
| 09/17/2018 |
Orthopedic |
11-334 |
Complete |
ASTM |
F1829-17 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 08/21/2017 |
Software/
Informatics |
13-97 |
Complete |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
| 01/14/2019 |
Anesthesiology |
1-120 |
Complete |
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 |
6-410 |
Complete |
ISO |
8536-6 Third edition 2016-12-01 |
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles |
| 09/17/2018 |
Orthopedic |
11-335 |
Complete |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
| 12/23/2016 |
Orthopedic |
11-317 |
Complete |
ASTM |
F3129-16 |
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
| 08/21/2017 |
Anesthesiology |
1-124 |
Complete |
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 |
| 08/21/2017 |
Materials |
8-455 |
Complete |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 12/18/2023 |
Orthopedic |
11-406 |
Complete |
ASTM |
F3141-23 |
Standard Guide for Total Knee Replacement Loading Profiles |
| 11/08/2005 |
Radiology |
12-6 |
Complete |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
| 04/04/2016 |
Materials |
8-408 |
Complete |
ASTM |
F3122-14 |
Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes |
| 08/21/2017 |
Materials |
8-457 |
Complete |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
| 12/21/2020 |
Dental/
ENT |
4-265 |
Complete |
ISO |
10271 Third edition 2020-08 |
Dentistry - Corrosion test methods for metallic materials |
| ANSI ADA |
Standard No. 97-2020 |
Corrosion Test Methods for Metallic Materials |
| 06/07/2021 |
Orthopedic |
11-377 |
Complete |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
| 12/18/2023 |
Anesthesiology |
1-162 |
Complete |
ISO |
10651-4 Second edition 2023-03 |
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators |
| 12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-492 |
Complete |
ASTM |
F2100-23 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-411 |
Complete |
ASTM |
D6499-18 |
Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| 01/14/2019 |
Cardiovascular |
3-157 |
Complete |
ANSI AAMI ISO |
25539-1: 2017 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 12/18/2023 |
Dental/
ENT |
4-311 |
Complete |
ISO |
9917-2 Third edition 2017-09 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 07/26/2016 |
Biocompatibility |
2-227 |
Complete |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
| 01/27/2015 |
Dental/
ENT |
4-136 |
Complete |
ASTM |
F2504-05 (Reapproved 2022) |
Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
| 07/09/2014 |
Dental/
ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
| 01/14/2019 |
Orthopedic |
11-272 |
Complete |
ASTM |
F1714-96 (Reapproved 2018) |
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| 01/14/2019 |
Orthopedic |
11-344 |
Complete |
ASTM |
F2580-18 |
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| 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 |
| 08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-382 |
Complete |
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 |
| 12/18/2023 |
Biocompatibility |
2-302 |
Complete |
ASTM |
F981-23 |
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
| 12/23/2016 |
Biocompatibility |
2-94 |
Complete |
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 |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-356 |
Complete |
ASTM |
D5712-15(2020) |
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 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 10/04/2004 |
InVitro Diagnostics |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
| 03/18/2009 |
Software/
Informatics |
13-28 |
Complete |
CLSI |
AUTO9-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| 03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 01/15/2013 |
Software/
Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
| 04/04/2016 |
Ophthalmic |
10-100 |
Complete |
ISO |
18259 First Edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
| 01/14/2019 |
Orthopedic |
11-346 |
Complete |
ASTM |
F2706-18 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
| 12/04/2017 |
Software/
Informatics |
13-101 |
Complete |
ISO IEC |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
| 05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
| 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 |
| 12/04/2017 |
Software/
Informatics |
13-100 |
Complete |
ISO IEC |
15459-4 Third edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages |
| 03/16/2012 |
Sterility |
14-332 |
Complete |
ISO |
11140-5 Second edition 2007-03-15 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| ANSI AAMI ISO |
11140-5:2007/(R)2012 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
| 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)] |
| 01/14/2019 |
InVitro Diagnostics |
7-286 |
Complete |
CLSI |
M11 9th Edition |
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| 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 |
| 08/21/2017 |
Software/
Informatics |
13-89 |
Complete |
ISO IEEE |
11073-10406 First edition 2012-12-01 |
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 08/21/2017 |
Dental/
ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 01/14/2019 |
Biocompatibility |
2-141 |
Complete |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 06/07/2018 |
Tissue Engineering |
15-54 |
Complete |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| 06/07/2018 |
Biocompatibility |
2-250 |
Complete |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
| 01/14/2019 |
Materials |
8-488 |
Complete |
ASTM |
F3301-18a |
Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion |
| 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 |
| 09/17/2018 |
Ophthalmic |
10-112 |
Complete |
ISO |
11986 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
| 09/17/2018 |
Anesthesiology |
1-140 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-123 |
Complete |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 06/07/2018 |
Materials |
8-113 |
Complete |
ASTM |
F1147-05 (Reapproved 2017)e1 |
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| 04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-409 |
Complete |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
| 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 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| 09/17/2018 |
Dental/
ENT |
4-242 |
Complete |
ISO |
10139-1 Third edition 2018-03 |
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
| ANSI ADA |
Standard No. 75-2020 |
Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
| 08/14/2015 |
Orthopedic |
11-183 |
Complete |
ASTM |
F1875-98 (Reapproved 2022) |
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface |
| 12/23/2016 |
Orthopedic |
11-319 |
Complete |
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 |
| 12/18/2023 |
Orthopedic |
11-405 |
Complete |
ASTM |
F1829-23 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 05/29/2023 |
InVitro Diagnostics |
7-315 |
Complete |
CLSI |
EP12 3rd Edition |
Evaluation of Qualitative, Binary Output Examination Performance |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
| 07/09/2014 |
Sterility |
14-257 |
Complete |
ASTM |
D3078-02 (Reapproved 2021)e1 |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
| 08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
| 12/18/2023 |
Orthopedic |
11-404 |
Complete |
ASTM |
F2887-23 |
Standard Specification for Total Elbow Prostheses |
| 08/21/2017 |
Orthopedic |
11-321 |
Complete |
ASTM |
F2887-17 |
Standard Specification for Total Elbow Prostheses |
| 01/14/2019 |
Tissue Engineering |
15-47 |
Complete |
ISO |
22442-3 First edition 2007-12-15 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. |
| 08/21/2017 |
General II (ES/
EMC) |
19-25 |
Complete |
IEC |
62485-1 Edition 1.0 2015-04 |
Safety requirements for secondary batteries and battery installations - Part 1: General safety information. |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-296 |
Complete |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-488 |
Complete |
ASTM |
F1671/F1671M-22 |
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 |
| 04/04/2016 |
Materials |
8-115 |
Complete |
ASTM |
F2256-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading |
| 04/04/2016 |
Materials |
8-136 |
Complete |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
| 08/06/2013 |
Materials |
8-153 |
Complete |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
| 08/06/2013 |
Materials |
8-158 |
Complete |
ASTM |
F1713-08 (Reapproved 2013) |
Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
| 04/04/2016 |
Physical Medicine |
16-195 |
Complete |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
| 04/04/2016 |
Radiology |
12-188 |
Complete |
NEMA |
MS-1-2008 (R2020) |
Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging |
| 04/04/2016 |
Radiology |
12-187 |
Complete |
NEMA |
MS 3-2008 (R2020) |
Determination of Image Uniformity in Diagnostic Magnetic Resonance Images |
| 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 |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-489 |
Complete |
IEC |
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
|
| 07/06/2020 |
Orthopedic |
11-368 |
Complete |
ASTM |
F3334-19 |
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| 12/23/2019 |
Materials |
8-520 |
Complete |
ASTM |
F799-19 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
| 12/21/2020 |
Sterility |
14-554 |
Complete |
ASTM |
F17-20 |
Standard Terminology Relating to Flexible Barrier Packaging |
| 08/21/2017 |
Biocompatibility |
2-247 |
Complete |
ISO |
10993-6 Third edition 2016-12-01 |
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |
| 07/09/2014 |
Anesthesiology |
1-101 |
Complete |
CGA |
C-9:2013 |
Standard Color Marking of Compressed Gas Containers for Medical Use |
| 07/09/2014 |
Dental/
ENT |
4-165 |
Complete |
ANSI ASA |
S3.13-1987 (Reaffirmed 2020) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
| 04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
| 08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 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 |
| 04/04/2016 |
Physical Medicine |
16-197 |
Complete |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| 04/04/2016 |
Physical Medicine |
16-198 |
Complete |
ISO |
7176-22 Second edition 2014-09-01 |
Wheelchairs - Part 22: Set-up procedures |
| 01/27/2015 |
General I (QS/
RM) |
5-48 |
Complete |
ANSI |
Z1.9-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-125 |
Complete |
ISO CIE |
11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 |
Colorimetry - Part 2: CIE standard illuminants |
| 07/09/2014 |
Orthopedic |
11-276 |
Complete |
ASTM |
F1798-13 |
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 08/21/2017 |
Materials |
8-195 |
Complete |
ASTM |
F2024-10 (Reapproved 2016) |
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
| 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 |
| 01/14/2019 |
Cardiovascular |
3-66 |
Complete |
ASTM |
F2081-06 (Reapproved 2017) |
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 01/30/2014 |
Dental/
ENT |
4-188 |
Complete |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-149 |
Complete |
IEC |
60601-2-39 Edition 3.0 2018-04 |
Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
|
| 05/29/2023 |
Radiology |
12-351 |
Complete |
IEC |
60601-2-43 Edition 3.0 2022-12 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
| 12/18/2023 |
Dental/
ENT |
4-313 |
Complete |
ISO |
27020 Second edition 2019-06 |
Dentistry - Brackets and tubes for use in orthodontics |
| ANSI ADA |
Standard No.100-2020 |
Orthodontic Brackets and Tubes |
| 08/21/2017 |
Orthopedic |
11-242 |
Complete |
ASTM |
F1839-08 (Reapproved 2016) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 09/09/2008 |
InVitro Diagnostics |
7-163 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
| 10/04/2010 |
Radiology |
12-215 |
Complete |
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 |
Radiology |
12-174 |
Complete |
ISO |
13697 First edition 2006-05-15 |
Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
| 03/16/2012 |
Dental/
ENT |
4-173 |
Complete |
ANSI ASA |
S3.44-1996 (Reaffirmed 2006) |
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment |
| 01/30/2014 |
InVitro Diagnostics |
7-223 |
Complete |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2014) |
Standard Specification for Soft-Tissue Expander Devices |
| 12/18/2023 |
Dental/
ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 12/18/2023 |
Dental/
ENT |
4-322 |
Complete |
ISO |
18675 First edition 2022-05 |
Dentistry - Machinable ceramic blanks |
| 12/18/2023 |
Dental/
ENT |
4-323 |
Complete |
ISO |
5139 First edition 2023-05 |
Dentistry - Polymer-based composite machinable blanks |
| 12/18/2023 |
Dental/
ENT |
4-324 |
Complete |
ISO |
TS 16506 First edition 2018-03 |
Dentistry - Polymer-based luting materials containing adhesive components |
| 01/30/2014 |
Anesthesiology |
1-97 |
Complete |
CGA |
V-7.1:2011 |
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases |
| 08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| 03/16/2012 |
Anesthesiology |
1-62 |
Complete |
ISO |
5356-1 Third edition 2004-05-15 |
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
| ANSI AAMI ISO |
5356-1:2004 |
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets |
| 06/27/2016 |
Orthopedic |
11-308 |
Complete |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 08/21/2017 |
Tissue Engineering |
15-49 |
Complete |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| 01/14/2019 |
Cardiovascular |
3-79 |
Complete |
ASTM |
F2079-09 (Reapproved 2017) |
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| 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 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| 06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| 07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| 06/27/2016 |
Sterility |
14-481 |
Complete |
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 |
| 07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
| 12/04/2017 |
Software/
Informatics |
13-98 |
Complete |
ISO IEC |
646 Third edition 1991-12-15 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
| INCITS ISO IEC |
646:1991 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
| 09/11/2023 |
Orthopedic |
11-400 |
Complete |
ISO |
21536 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants |
| 01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
| 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 |
| 06/27/2016 |
Orthopedic |
11-307 |
Complete |
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 |
Complete |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-407 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 04/04/2016 |
Sterility |
14-277 |
Complete |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
| ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
| 07/15/2019 |
Orthopedic |
11-357 |
Complete |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| 12/23/2019 |
Orthopedic |
11-361 |
Complete |
ISO |
14243-5 First edition 2019-05 |
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
| 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 |
| 08/06/2013 |
Cardiovascular |
3-115 |
Complete |
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 |
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 |
| 12/19/2022 |
Radiology |
12-349 |
Complete |
NEMA |
PS 3.1 - 3.20 2022d |
Digital Imaging and Communications in Medicine (DICOM) Set |
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