|
|
|
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)
|
| 12/19/2022 |
Nanotechnology |
18-21 |
Complete |
ISO |
TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
| 12/21/2020 |
Neurology |
17-17 |
Complete |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder Devices |
| 05/26/2025 |
Neurology |
17-22 |
Complete |
IEC |
60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 06/07/2018 |
Neurology |
17-16 |
Complete |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 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)] |
| 05/26/2025 |
Neurology |
17-20 |
Complete |
IEC |
60601-2-40 Third edition 2024-12 |
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| 06/07/2018 |
Neurology |
17-15 |
Complete |
ISO |
14708-3 Second edition 2017-04 |
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| 01/14/2019 |
Neurology |
17-14 |
Complete |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 05/29/2024 |
Neurology |
17-18 |
Complete |
IEEE |
Std 2010-2023 |
Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems |
| 06/07/2018 |
Neurology |
17-1 |
Partial |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
| 05/25/2026 |
Neurology |
17-23 |
Partial |
IEC |
80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION |
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| 05/29/2024 |
Neurology |
17-19 |
Partial |
ISO |
80601-2-85 Edition 1.0 2021-03 |
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment |
| 08/14/2015 |
Neurology |
17-4 |
Partial |
ASTM |
F647-94 (Reapproved 2014) |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 05/26/2025 |
Neurology |
17-21 |
Partial |
ASTM |
F647-22 |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-140 |
Partial |
ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-136 |
Partial |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-155 |
Partial |
ISO |
23500-4 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 12/23/2019 |
ObGyn/
Gastroenterology/
Urology |
9-123 |
Partial |
ISO |
8600-3 Second edition 2019-08 |
Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-152 |
Partial |
ISO |
23500-1 Second edition 2024-08 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 05/26/2025 |
ObGyn/
Gastroenterology/
Urology |
9-151 |
Complete |
ASTM |
F1828-22 |
Standard Specification for Ureteral Stents |
| 09/09/2008 |
ObGyn/
Gastroenterology/
Urology |
9-7 |
Complete |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-118 |
Partial |
ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
| 01/27/2015 |
ObGyn/
Gastroenterology/
Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-115 |
Complete |
ISO |
29943-1 First edition 2017-07. |
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-126 |
Complete |
ISO CIE |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
| 08/06/2013 |
ObGyn/
Gastroenterology/
Urology |
9-31 |
Complete |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
| 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)] |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-117 |
Complete |
ISO |
16038 Second edition 2017-11 |
Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-120 |
Complete |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-119 |
Complete |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-154 |
Complete |
ISO |
23500-3 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 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 |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-86 |
Complete |
ISO |
16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
| 08/14/2015 |
ObGyn/
Gastroenterology/
Urology |
9-108 |
Complete |
ISO |
8009 Second edition 2014-11-15 |
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 12/21/2020 |
ObGyn/
Gastroenterology/
Urology |
9-130 |
Complete |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| 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 |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-116 |
Complete |
ISO |
29943-2 First edition 2017-07 |
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports. |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 12/18/2023 |
ObGyn/
Gastroenterology/
Urology |
9-150 |
Complete |
ISO |
7439 Fourth edition 2023-04 |
Copper-bearing contraceptive intrauterine devices - Requirements and tests |
| 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 |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-148 |
Complete |
ISO CIE |
11664-6 Second edition 2022-08 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-153 |
Complete |
ISO |
23500-2 Second edition 2024-07 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-156 |
Complete |
ISO |
23500-5 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
| 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
|
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-68 |
Complete |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-111 |
Complete |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-142 |
Complete |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| 05/30/2022 |
ObGyn/
Gastroenterology/
Urology |
9-139 |
Complete |
CIE ISO |
11664-5:2016 |
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-145 |
Complete |
ASTM |
D7661-18 |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-146 |
Complete |
ISO |
8600-4 Third Edition 2023-01 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 07/15/2019 |
Ophthalmic |
10-117 |
Complete |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 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 |
| 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 |
| 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 |
| 06/07/2021 |
Ophthalmic |
10-126 |
Complete |
IEC |
80601-2-58 Edition 2.0 2014-09 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| ANSI AAMI IEC |
80601-2-58:2014 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| 12/19/2022 |
Ophthalmic |
10-133 |
Complete |
ISO |
11979-10 Second edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
| 08/06/2013 |
Ophthalmic |
10-77 |
Complete |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| 12/20/2021 |
Ophthalmic |
10-129 |
Complete |
ASTM |
D790-17 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| 12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
| 05/30/2022 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
| 08/02/2011 |
Ophthalmic |
10-66 |
Complete |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
| 08/14/2015 |
Ophthalmic |
10-99 |
Complete |
ISO |
4311 First edition 1979-06-01 |
Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring |
| 09/17/2018 |
Ophthalmic |
10-113 |
Complete |
ANSI |
Z80.30-2018 (R2023) |
American National Standard for Ophthalmics - Toric Intraocular Lenses |
| 05/26/2025 |
Ophthalmic |
10-137 |
Complete |
ISO |
11979-2 Third edition 2024-10 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| 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 |
| 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 |
| 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 |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 12/21/2020 |
Ophthalmic |
10-120 |
Complete |
ISO |
TR 22979 Second Edition 2017-05 |
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| 09/17/2018 |
Ophthalmic |
10-84 |
Complete |
ANSI |
Z80.11-2012 (R2022) |
American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping |
| 12/21/2020 |
Ophthalmic |
10-121 |
Complete |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
| 06/07/2018 |
Ophthalmic |
10-107 |
Complete |
ISO |
18369-4 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| 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 |
| 06/07/2021 |
Ophthalmic |
10-124 |
Complete |
ISO |
11979-1 Fourth edition 2018-11 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| 08/14/2015 |
Ophthalmic |
10-94 |
Complete |
ISO |
14730 Second edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date |
| 08/14/2015 |
Ophthalmic |
10-95 |
Complete |
ISO |
11979-6 Third edition 2014-10-01 |
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
| 12/22/2025 |
Ophthalmic |
10-139 |
Complete |
ISO |
11980 Fourth edition 2025-06 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 12/22/2025 |
Ophthalmic |
10-140 |
Complete |
ANSI |
Z80.1-2020 |
American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations |
| 12/20/2021 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| 06/07/2018 |
Ophthalmic |
10-105 |
Complete |
ISO |
11979-8 Third edition 2017-04 |
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
| 06/07/2018 |
Ophthalmic |
10-106 |
Complete |
ISO |
18369-3 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
| 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 |
| 01/14/2019 |
Ophthalmic |
10-114 |
Complete |
ANSI |
Z80.28-2017 |
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes |
| 12/22/2025 |
Ophthalmic |
10-141 |
Complete |
ISO |
11978 Third edition 2017-08 [Including AMD1:2020] |
Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)] |
| 09/21/2016 |
Ophthalmic |
10-101 |
Complete |
ISO |
18189 First edition 2016-06-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
| 12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
| 06/07/2018 |
Ophthalmic |
10-109 |
Complete |
ISO |
18369-1 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications |
| 08/21/2017 |
Ophthalmic |
10-103 |
Complete |
ANSI |
Z80.18-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology |
| 01/14/2019 |
Ophthalmic |
10-93 |
Partial |
ANSI |
Z80.27-2014 (R2025) |
American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| 05/29/2024 |
Ophthalmic |
10-134 |
Partial |
ISO |
10943 Fourth edition 2023-01 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 05/29/2024 |
Ophthalmic |
10-135 |
Partial |
ISO |
11979-7 Fifth edition 2024-01 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
| 06/07/2021 |
Ophthalmic |
10-123 |
Partial |
ISO |
15004-1 Second edition 2020-5 |
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
| 08/21/2017 |
Ophthalmic |
10-104 |
Partial |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| 07/15/2019 |
Ophthalmic |
10-89 |
Partial |
ANSI |
Z80.7-2013 (R2023) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
| 01/14/2019 |
Ophthalmic |
10-74 |
Partial |
ISO |
10940 Second edition 2009-08-01 |
Ophthalmic instruments - Fundus cameras |
| 01/14/2019 |
Ophthalmic |
10-86 |
Partial |
ISO |
14729 First edition 2001-04-15 |
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
| 01/14/2019 |
Ophthalmic |
10-85 |
Partial |
ISO |
11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 07/15/2019 |
Ophthalmic |
10-116 |
Partial |
ANSI |
Z80.35-2018 (R2023) |
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
| 01/14/2019 |
Ophthalmic |
10-108 |
Partial |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| 05/29/2024 |
Ophthalmic |
10-136 |
Complete |
IEC |
80601-2-58 Edition 3.0 2024-03 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| ANSI AAMI IEC |
80601-2-58:2024 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| 12/19/2022 |
Ophthalmic |
10-132 |
Partial |
ISO |
10942 Third edition 2022-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
| 06/07/2021 |
Ophthalmic |
10-122 |
Partial |
ISO |
10939 Third edition 2017-05 |
Ophthalmic instruments - Slit-lamp microscopes |
| 05/26/2025 |
Ophthalmic |
10-138 |
Partial |
ISO |
16971-1 First edition 2024-11 |
Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye |
| 05/26/2025 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| 12/21/2020 |
Orthopedic |
11-330 |
Partial |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
| 01/14/2019 |
Orthopedic |
11-348 |
Partial |
ISO |
19227 First edition 2018-03 |
Implants for surgery - Cleanliness of orthopedic implants - General requirements |
| 12/22/2025 |
Orthopedic |
11-433 |
Partial |
ASTM |
F2028-25a |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening |
| 12/23/2024 |
Orthopedic |
11-410 |
Complete |
ASTM |
F3161-24 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 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)] |
| 12/18/2023 |
Orthopedic |
11-408 |
Complete |
ASTM |
F2777-23 |
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
| 12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| 01/14/2019 |
Orthopedic |
11-184 |
Partial |
ISO |
8827 First edition 1988-10-15 |
Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
| 09/17/2018 |
Orthopedic |
11-333 |
Complete |
ASTM |
F382-17 |
Standard Specification and Test Method for Metallic Bone Plates |
| 07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| 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 |
| 01/30/2014 |
Orthopedic |
11-274 |
Complete |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
| 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 |
| 07/06/2020 |
Orthopedic |
11-363 |
Complete |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| 07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 08/21/2017 |
Orthopedic |
11-175 |
Complete |
ASTM |
F1582-98 (Reapproved 2016) |
Standard Terminology Relating to Spinal Implants |
| 08/21/2017 |
Orthopedic |
11-309 |
Complete |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
| 07/15/2019 |
Orthopedic |
11-354 |
Complete |
ASTM |
F3295-18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
| 12/23/2024 |
Orthopedic |
11-415 |
Complete |
ASTM |
F2554-22 |
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems |
| 12/23/2024 |
Orthopedic |
11-416 |
Complete |
ASTM |
F2996-24 |
Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 04/04/2016 |
Orthopedic |
11-304 |
Complete |
ASTM |
F3107-14 (Reapproved 2023) |
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 2024) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
| 01/30/2014 |
Orthopedic |
11-232 |
Complete |
ISO |
7207-1 Third edition 2007-02-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
| 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)] |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 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 |
| 12/23/2016 |
Orthopedic |
11-314 |
Complete |
ISO |
14242-2 Second edition 2016-09-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement |
| 08/14/2015 |
Orthopedic |
11-290 |
Complete |
ISO |
8828 Second edition 2014-11-15 |
Implants for surgery -- Guidance on care and handling of orthopaedic implants |
| 12/23/2024 |
Orthopedic |
11-413 |
Complete |
ASTM |
F543-23 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
| 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 |
| 09/17/2018 |
Orthopedic |
11-336 |
Complete |
ISO |
17853 Third edition 2011-03-01 |
Wear of implant materials - Polymer and metal wear particles - Isolation and characterization |
| 12/20/2021 |
Orthopedic |
11-387 |
Complete |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| 01/14/2019 |
Orthopedic |
11-272 |
Complete |
ASTM |
F1714-96 (Reapproved 2025) |
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| 12/23/2024 |
Orthopedic |
11-412 |
Complete |
ASTM |
F3129-24 |
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
| 08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| 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 |
Orthopedic |
11-368 |
Complete |
ASTM |
F3334-19 |
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| 12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
| 09/17/2018 |
Orthopedic |
11-338 |
Complete |
ISO |
11491 First edition 2017-07 |
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
| 12/23/2024 |
Orthopedic |
11-418 |
Complete |
ASTM |
F3631-24 |
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
|
| 05/25/2026 |
Orthopedic |
11-444 |
Complete |
ISO |
18192-3 Second edition 2025-11 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses |
| 08/21/2017 |
Orthopedic |
11-280 |
Complete |
ASTM |
F2624-12 (Reapproved 2020) |
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
| 12/23/2016 |
Orthopedic |
11-311 |
Complete |
ISO |
14243-2 Third edition 2016-09-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement |
| 09/17/2018 |
Orthopedic |
11-327 |
Complete |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
| 12/23/2024 |
Orthopedic |
11-414 |
Complete |
ASTM |
F382-24 |
Standard Specification and Test Method for Metallic Bone Plates |
| 01/30/2014 |
Orthopedic |
11-74 |
Complete |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
| 01/30/2014 |
Orthopedic |
11-75 |
Complete |
ISO |
5838-3 First edition 1993-09-15 |
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
| 12/21/2020 |
Orthopedic |
11-374 |
Complete |
ISO |
7207-2 Second edition 2011-07-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)] |
| 05/25/2026 |
Orthopedic |
11-441 |
Complete |
ASTM |
F2789-25 |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 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 |
| 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 |
| 12/22/2025 |
Orthopedic |
11-438 |
Complete |
ASTM |
F2502-24 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/23/2024 |
Orthopedic |
11-417 |
Complete |
ASTM |
F3090-24 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 12/23/2024 |
Orthopedic |
11-411 |
Complete |
ASTM |
F1611-20 (Reapproved 2024) |
Standard Specification for Intramedullary Reamers |
| 09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 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 |
| 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)] |
| 07/06/2020 |
Orthopedic |
11-369 |
Complete |
ASTM |
F3292-19 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 12/22/2025 |
Orthopedic |
11-440 |
Complete |
ASTM |
F3738-25 |
Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles |
| 05/25/2026 |
Orthopedic |
11-446 |
Complete |
ASTM |
F3574-25 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
| 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 |
| 08/06/2013 |
Orthopedic |
11-252 |
Complete |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
| 12/23/2019 |
Orthopedic |
11-360 |
Complete |
ASTM |
F1378-18e1 |
Standard Specification for Shoulder Prostheses |
| 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 |
| 12/22/2025 |
Orthopedic |
11-435 |
Complete |
ASTM |
F3292-25 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
| 09/17/2018 |
Orthopedic |
11-337 |
Complete |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
| 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 |
| 12/23/2019 |
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 |
| 04/04/2016 |
Orthopedic |
11-247 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 05/25/2026 |
Orthopedic |
11-442 |
Complete |
ISO |
7206-12 Second edition 2025-11 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components |
| 12/22/2025 |
Orthopedic |
11-436 |
Complete |
ISO |
7207-2 Third edition 2025-08 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
| 06/07/2021 |
Orthopedic |
11-383 |
Complete |
ASTM |
F3143-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
| 06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/22/2025 |
Orthopedic |
11-439 |
Complete |
ASTM |
F3437-23 |
Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
| 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 |
| 08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
| 05/25/2026 |
Orthopedic |
11-445 |
Complete |
ASTM |
F2009-25 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 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 |
| 06/07/2021 |
Orthopedic |
11-381 |
Complete |
ASTM |
F2582-20 |
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
| 06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 (Reapproved 2025) |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip 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 |
Orthopedic |
11-242 |
Complete |
ASTM |
F1839-08 (Reapproved 2021) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 12/23/2016 |
Orthopedic |
11-312 |
Complete |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
| 12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
| 07/15/2019 |
Orthopedic |
11-356 |
Complete |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| 12/19/2022 |
Orthopedic |
11-394 |
Complete |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| 09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
| 12/22/2025 |
Orthopedic |
11-428 |
Complete |
ASTM |
F1541-24 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 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 |
| 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 |
| 12/22/2025 |
Orthopedic |
11-427 |
Complete |
ASTM |
F1264-24 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-423 |
Complete |
ASTM |
F2267-24 |
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 09/11/2023 |
Orthopedic |
11-401 |
Complete |
ISO |
21535 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants |
| 12/18/2023 |
Orthopedic |
11-407 |
Complete |
ASTM |
F3140-23 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| 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 |
| 09/17/2018 |
Orthopedic |
11-185 |
Complete |
ASTM |
F2267-04 (Reapproved 2018) |
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 12/23/2024 |
Orthopedic |
11-419 |
Complete |
ASTM |
F3690-24 |
Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance |
| 12/22/2025 |
Orthopedic |
11-437 |
Complete |
ASTM |
F2033-25 |
Standard Specification for Hip Joint Replacement Bearing Surfaces |
| 12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 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 |
| 05/25/2026 |
Orthopedic |
11-443 |
Complete |
ASTM |
F2706-25 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
| 12/18/2023 |
Orthopedic |
11-404 |
Complete |
ASTM |
F2887-23 |
Standard Specification for Total Elbow Prostheses |
| 12/18/2023 |
Orthopedic |
11-405 |
Complete |
ASTM |
F1829-23 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 12/18/2023 |
Orthopedic |
11-406 |
Complete |
ASTM |
F3141-23 |
Standard Guide for Total Knee Replacement Loading Profiles |
| 12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| 12/22/2025 |
Orthopedic |
11-430 |
Complete |
ASTM |
F564-24 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 12/22/2025 |
Orthopedic |
11-429 |
Complete |
ASTM |
F366-24 |
Standard Specification for Fixation Pins and Wires |
| 12/22/2025 |
Orthopedic |
11-431 |
Complete |
ASTM |
F384-24 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| 09/17/2018 |
Orthopedic |
11-326 |
Complete |
ASTM |
F384-17 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-432 |
Complete |
ASTM |
F2180-24 |
Standard Specification for Metallic Implantable Strands and Cables |
| 05/26/2025 |
Orthopedic |
11-420 |
Complete |
ASTM |
F2580-24 |
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses |
| 01/14/2019 |
Orthopedic |
11-344 |
Complete |
ASTM |
F2580-18 |
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| 05/26/2025 |
Orthopedic |
11-421 |
Complete |
ASTM |
F2077-24 |
Standard Test Methods for Intervertebral Body Fusion Devices |
| 01/14/2019 |
Orthopedic |
11-347 |
Complete |
ASTM |
F2077-18 |
Test Methods for Intervertebral Body Fusion Devices |
| 12/20/2021 |
Orthopedic |
11-393 |
Complete |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
| 07/15/2019 |
Orthopedic |
11-352 |
Complete |
ISO |
14242-1 Third edition 2014-10-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 12/20/2021 |
Orthopedic |
11-385 |
Complete |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| 12/20/2021 |
Orthopedic |
11-386 |
Complete |
ASTM |
F2665-21 |
Standard Specification for Total Ankle Replacement Prosthesis |
| 12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| 12/22/2025 |
Orthopedic |
11-434 |
Complete |
ASTM |
F3018-25 |
Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 12/22/2025 |
Orthopedic |
11-426 |
Complete |
ASTM |
F2943-25 |
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants |
| 12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| 12/22/2025 |
Orthopedic |
11-424 |
Complete |
ASTM |
F983-24 |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| 09/17/2018 |
Orthopedic |
11-197 |
Complete |
ASTM |
F983-86 (Reapproved 2018) |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| 12/22/2025 |
Orthopedic |
11-425 |
Complete |
ASTM |
F565-21 |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 07/15/2019 |
Orthopedic |
11-358 |
Complete |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| 12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 12/19/2022 |
Orthopedic |
11-397 |
Complete |
ASTM |
F3210-22e1 |
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
| 12/18/2023 |
Orthopedic |
11-402 |
Complete |
ASTM |
F1798-21 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 12/19/2022 |
Orthopedic |
11-395 |
Complete |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| 12/19/2022 |
Orthopedic |
11-396 |
Complete |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
| 09/17/2018 |
Orthopedic |
11-329 |
Complete |
ASTM |
F2180-17 |
Standard Specification for Metallic Implantable Strands and Cables |
| 12/18/2023 |
Orthopedic |
11-403 |
Complete |
ASTM |
F3047M-23 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
| 05/26/2025 |
Orthopedic |
11-422 |
Complete |
ASTM |
F1798-24 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
| 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 |
| 12/21/2020 |
Orthopedic |
11-371 |
Complete |
ASTM |
F2009-20 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 09/17/2018 |
Orthopedic |
11-339 |
Complete |
ISO |
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
| 01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 (Reapproved 2025) |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| 01/30/2014 |
Physical Medicine |
16-27 |
Complete |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
| 12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 12/23/2019 |
Physical Medicine |
16-225 |
Complete |
RESNA ANSI |
WC-1:2019 Section 26 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
| 12/23/2019 |
Physical Medicine |
16-207 |
Complete |
RESNA ANSI |
WC-1:2019 Section 1 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability |
| 12/23/2019 |
Physical Medicine |
16-209 |
Complete |
RESNA ANSI |
WC-1:2019 Section 3 |
American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes |
| 12/23/2019 |
Physical Medicine |
16-210 |
Complete |
RESNA ANSI |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
| 12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
| 12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
| 12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
| 12/19/2022 |
Physical Medicine |
16-233 |
Complete |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
| 05/29/2023 |
Physical Medicine |
16-235 |
Complete |
ISO |
7176-25 Second Edition 2022 |
Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
| 05/29/2023 |
Physical Medicine |
16-236 |
Complete |
ISO |
7176-19 Third Edition 2022 |
Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles |
| 05/29/2023 |
Physical Medicine |
16-234 |
Complete |
ISO |
7176-14 Third Edition 2022 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
| 12/22/2025 |
Physical Medicine |
16-238 |
Complete |
ISO |
11199-1 Second edition 2021-05 |
Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames |
| 12/22/2025 |
Physical Medicine |
16-239 |
Complete |
ISO |
11199-2 Third edition 2021-07 [Including AMD1:2024] |
Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]. |
| 12/23/2019 |
Physical Medicine |
16-223 |
Complete |
RESNA ANSI |
WC-1:2019 Section 22 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures |
| 12/23/2019 |
Physical Medicine |
16-224 |
Complete |
RESNA ANSI |
WC-2:2019 Section 21 |
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters |
| 12/23/2019 |
Physical Medicine |
16-211 |
Complete |
RESNA ANSI |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
| 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 |
| 12/23/2019 |
Physical Medicine |
16-213 |
Complete |
RESNA ANSI |
WC-1:2019 Section 7 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions |
| 12/23/2019 |
Physical Medicine |
16-208 |
Complete |
RESNA ANSI |
WC-2:2019 Section 2 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-212 |
Complete |
RESNA ANSI |
WC-2:2019 Section 6 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs. |
| 12/23/2019 |
Physical Medicine |
16-215 |
Complete |
RESNA ANSI |
WC-2:2019 Section 9 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs |
| 08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
| 12/23/2019 |
Physical Medicine |
16-222 |
Complete |
RESNA ANSI |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
| 12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
| 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 |
| 12/23/2019 |
Physical Medicine |
16-218 |
Complete |
RESNA ANSI |
WC-1:2019 Section 13 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces |
| 01/30/2014 |
Physical Medicine |
16-163 |
Complete |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
| 12/22/2025 |
Physical Medicine |
16-237 |
Complete |
ASME |
A18.1-2023 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 01/30/2014 |
Physical Medicine |
16-167 |
Complete |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
| 01/30/2014 |
Physical Medicine |
16-164 |
Complete |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 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 |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
| 12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
| 09/17/2018 |
Physical Medicine |
16-203 |
Complete |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 05/25/2026 |
Physical Medicine |
16-241 |
Complete |
ISO |
7176-31 First edition 2023-05 |
Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requirements and test methods |
| 05/25/2026 |
Physical Medicine |
16-240 |
Complete |
ISO |
7176-21 Third edition 2025-04 |
Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 04/04/2016 |
Physical Medicine |
16-195 |
Complete |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
| 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 |
| 09/17/2018 |
Physical Medicine |
16-202 |
Complete |
ISO |
7176-2 Third edition 2017-10 |
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| 04/04/2016 |
Physical Medicine |
16-196 |
Complete |
ISO |
7176-7 First Edition 1998-05-15 |
Wheelchairs - Part 7: Measurement of seating and wheel dimensions |
| 12/23/2019 |
Physical Medicine |
16-214 |
Complete |
RESNA ANSI |
WC-1:2019 Section 8 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths |
| 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. |
| 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 |
| 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 |
| 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 |
| 01/30/2014 |
Physical Medicine |
16-25 |
Complete |
ISO |
7176-13 First edition 1989-08-01 |
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces |
| 01/30/2014 |
Physical Medicine |
16-162 |
Complete |
ISO |
7176-4 Third edition 2008-10-01 |
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
| 08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 05/30/2022 |
Physical Medicine |
16-166 |
Partial |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
| 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 |
| 03/16/2012 |
Radiology |
12-242 |
Complete |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| 12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
| 12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 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 |
| 04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
| 05/26/2025 |
Radiology |
12-374 |
Complete |
ISO |
24013 Second edition 2023-06 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
| 01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
| 01/30/2014 |
Radiology |
12-264 |
Complete |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
| 06/07/2018 |
Radiology |
12-312 |
Complete |
IEC |
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION |
Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
| 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 |
| 12/22/2025 |
Radiology |
12-384 |
Complete |
ICDM |
IDMS Version 1.3 May 31 2025 |
Information Display Measurements Standard |
| 06/27/2016 |
Radiology |
12-297 |
Complete |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
| 06/27/2016 |
Radiology |
12-298 |
Complete |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
| 06/27/2016 |
Radiology |
12-294 |
Complete |
IEC |
60601-2-45 Edition 3.1 2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| 06/07/2018 |
Radiology |
12-314 |
Complete |
ISO |
11554 Fourth edition 2017-07 |
Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics |
| 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 |
| 09/17/2018 |
Radiology |
12-318 |
Complete |
IEC |
60601-2-64 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| 09/17/2018 |
Radiology |
12-320 |
Complete |
IEC |
62667 Edition 1.0 2017-08 |
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| 08/14/2015 |
Radiology |
12-292 |
Complete |
IEEE |
Std 3333.2.1-2015 |
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
| 08/14/2015 |
Radiology |
12-289 |
Complete |
IEC |
62220-1-1 Edition 1.0 2015-03 |
Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging |
| 04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
| 08/21/2017 |
Radiology |
12-306 |
Complete |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
| 03/31/2006 |
Radiology |
12-137 |
Complete |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
| 03/31/2006 |
Radiology |
12-138 |
Complete |
ISO |
5799 Second edition 1991-08-01 |
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
| 08/06/2013 |
Radiology |
12-211 |
Complete |
IEC |
60601-2-29 Edition 3.0 2008-06 |
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| 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 |
| 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 |
| 07/09/2014 |
Radiology |
12-273 |
Complete |
IEC |
60825-1 Edition 2.0 2007-03 |
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| 03/16/2012 |
Radiology |
12-175 |
Complete |
ISO |
24013 First edition 2006-11-15 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
| 07/09/2014 |
Radiology |
12-194 |
Complete |
ANSI HPS |
N43.6-2007 (R2013) |
Sealed Radioactive Sources - Classification |
| 09/09/2008 |
Radiology |
12-165 |
Complete |
NEMA |
XR 22-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography |
| 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 [Including: Corrigendum 1 (2022)] |
| 03/16/2012 |
Radiology |
12-134 |
Complete |
ISO |
11146-1 First edition 2005-01-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 05/29/2024 |
Radiology |
12-361 |
Complete |
ICDM |
IDMS Version 1.2 May 2023 |
Information Display Measurements Standard |
| 05/26/2025 |
Radiology |
12-369 |
Complete |
ISO |
11146-1 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 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 |
| 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 |
| 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 |
| 06/07/2018 |
Radiology |
12-316 |
Complete |
IEC |
62359 Edition 2.1 2017-09 CONSOLIDATED VERSION |
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| 12/19/2007 |
Radiology |
12-176 |
Complete |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| 03/31/2006 |
Radiology |
12-141 |
Complete |
IEEE |
N42.13-2004 |
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
| 12/23/2024 |
Radiology |
12-362 |
Complete |
IEC |
61674 Edition 3.0 2024-07 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| 03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
| 12/23/2024 |
Radiology |
12-365 |
Complete |
IEC |
60627 Edition 3.0 2013-07 |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| 06/07/2018 |
Radiology |
12-315 |
Complete |
NEMA |
MS 8-2016 (R2003) |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
| 12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
| 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 |
| 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. |
| 07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
| 07/06/2020 |
Radiology |
12-325 |
Complete |
NEMA |
Standards Publication XR 25 -2019 |
Computed Tomography Dose Check |
| 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 (2022)] |
| 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 |
| 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 |
| 05/26/2025 |
Radiology |
12-381 |
Complete |
IEC |
60601-2-68 Edition 2.0 2025-02 |
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 |
| 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 |
| 12/23/2016 |
Radiology |
12-304 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| 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 |
| 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 |
12-241 |
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 |
| 08/06/2013 |
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 |
| 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 |
| 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 |
| 07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 (R2023) |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 01/14/2019 |
Radiology |
12-322 |
Complete |
NEMA |
MS 5-2018 |
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
| 01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
| 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 |
| 05/26/2025 |
Radiology |
12-367 |
Complete |
ISO |
13695 Second edition 2024-11 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 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 |
| 07/09/2014 |
Radiology |
12-282 |
Complete |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 05/26/2025 |
Radiology |
12-379 |
Complete |
IEC |
62127-2 Edition 2.0 2025-01 |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-380 |
Complete |
IEC |
60601-2-37 Edition 3.0 2024-07 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 01/30/2014 |
Radiology |
12-262 |
Complete |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
| 03/14/2011 |
Radiology |
12-217 |
Complete |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| 03/14/2011 |
Radiology |
12-221 |
Complete |
IEC |
61223-3-4 First edition 2000-03 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
| 03/16/2012 |
Radiology |
12-143 |
Complete |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
| 03/16/2012 |
Radiology |
12-248 |
Complete |
ISO |
21254-3 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
| 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 |
| 08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
| 03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
| 05/26/2025 |
Radiology |
12-372 |
Complete |
ISO |
14880-3 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 05/26/2025 |
Radiology |
12-373 |
Complete |
ISO |
14880-4 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 12/23/2024 |
Radiology |
12-363 |
Complete |
NEMA |
PS 3.1 - 3.20 2024e |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 05/27/2005 |
Radiology |
12-121 |
Complete |
IEC |
61847: 1998 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0 |
| 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 |
| 05/26/2025 |
Radiology |
12-378 |
Complete |
ISO |
12609-1 Second edition 2021-10 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 05/26/2025 |
Radiology |
12-377 |
Complete |
IEC |
62127-03 Edition 2.0 2022-12 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 03/16/2012 |
Radiology |
12-117 |
Complete |
ISO |
15367-1 First edition 2003-09-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects |
| 06/27/2016 |
Radiology |
12-293 |
Complete |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 05/30/2022 |
Radiology |
12-344 |
Complete |
IEC |
62563-2 Edition 1.0 2021-11 |
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
| 05/26/2025 |
Radiology |
12-383 |
Complete |
NEMA |
NU 1-2023 |
Performance Measurements of Gamma Cameras |
| 06/07/2021 |
Radiology |
12-337 |
Complete |
NEMA |
NU 1-2018 |
Performance Measurements of Gamma Cameras |
| 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 |
| 07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
| 06/07/2021 |
Radiology |
12-336 |
Complete |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 06/07/2021 |
Radiology |
12-338 |
Complete |
IEC |
60601-2-1 Edition 4.0 2020-10 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| 05/26/2025 |
Radiology |
12-375 |
Complete |
ANSI UL |
122-2019 |
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019] |
| 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 |
| 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 |
| 10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
| 05/29/2024 |
Radiology |
12-354 |
Complete |
NEMA |
MS 4-2023 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 05/29/2024 |
Radiology |
12-355 |
Complete |
IEC |
60601-2-57 Edition 2.0 2023-07 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use |
| 05/29/2024 |
Radiology |
12-356 |
Complete |
IEC |
60601-2-22 Edition 4.0 2019-11 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| 06/27/2016 |
Radiology |
12-301 |
Complete |
IEC |
60601-2-8 Edition 2.1 b:2015 |
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| 05/29/2023 |
Radiology |
12-350 |
Complete |
IEC |
60806 Edition 2.0 2022-11 |
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
| 03/16/2012 |
Radiology |
12-106 |
Complete |
ISO |
17526 First edition 2003-06-15 |
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers |
| 03/16/2012 |
Radiology |
12-246 |
Complete |
ISO |
21254-2 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination |
| 03/16/2012 |
Radiology |
12-245 |
Complete |
ISO |
21254-1 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles |
| 12/23/2024 |
Radiology |
12-364 |
Complete |
IEC |
61223-3-8 Edition 1.0 2024-03 |
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
|
| 12/23/2024 |
Radiology |
12-366 |
Complete |
IEC |
61223-3-6 Edition 1.0 2020-02 |
Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation |
| 03/31/2006 |
Radiology |
12-136 |
Complete |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
| 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)] |
| 05/29/2024 |
Radiology |
12-360 |
Complete |
IEC |
63145-10 Edition 1.0 2023-09 |
Eyewear display - Part 10: Specifications |
| 12/22/2025 |
Radiology |
12-385 |
Complete |
NEMA |
PS 3.1 - 3.20 2025d |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 08/06/2013 |
Radiology |
12-205 |
Complete |
IEC |
60601-2-5: Edition 3.0 2009-07 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| 05/26/2025 |
Radiology |
12-382 |
Complete |
NEMA |
NU 2-2024 |
Performance Measurements of Positron Emission Tomographs |
| 12/20/2021 |
Radiology |
12-341 |
Complete |
IEC |
62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION |
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
| 05/26/2025 |
Radiology |
12-376 |
Complete |
IEC |
61689 Edition 4.0 2022-03 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| 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 |
| 12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 07/12/1999 |
Radiology |
12-51 |
Complete |
IEC |
61145 (1992-05) |
Calibration and usage of ionization chamber systems for assay of radionuclides |
| 07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| 07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
| 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 |
| 05/30/2022 |
Radiology |
12-343 |
Complete |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| 06/07/2021 |
Radiology |
12-340 |
Complete |
IEC |
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
| 05/25/2026 |
Radiology |
12-386 |
Complete |
IEC |
63465 Edition 1.0 2026-01 |
Calibration and quality control in the use of radionuclide calibrators |
| 05/29/2024 |
Radiology |
12-357 |
Complete |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties |
| 05/29/2024 |
Radiology |
12-358 |
Complete |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display - Part 20-20: Fundamental measurement methods - Image quality |
| 05/29/2024 |
Radiology |
12-359 |
Complete |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties |
| 03/16/2012 |
Radiology |
12-142 |
Complete |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 05/26/2025 |
Radiology |
12-370 |
Complete |
ISO |
11146-2 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 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 |
| 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 |
| 05/26/2025 |
Radiology |
12-368 |
Complete |
ISO |
13696 Second edition 2022-06 |
Optics and photonics - Test methods for radiation scattered by optical components |
| 05/26/2025 |
Radiology |
12-371 |
Complete |
ISO |
14880-2 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 01/15/2013 |
Software/
Informatics |
13-36 |
Complete |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
| 06/27/2016 |
Software/
Informatics |
13-84 |
Complete |
ISO IEEE |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| 01/15/2013 |
Software/
Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
| 10/09/2023 |
Software/
Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
| 05/29/2024 |
Software/
Informatics |
13-135 |
Complete |
ISO IEEE |
11073-10407 Second edition 2022-12 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| IEEE |
Std 11073-10407-2020 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| 05/26/2025 |
Software/
Informatics |
13-148 |
Complete |
IEEE |
Std 11073-10417-2023 |
Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter |
| 08/14/2015 |
Software/
Informatics |
13-74 |
Complete |
IEEE |
Std 11073-10424-2014 |
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) |
| 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 |
| 08/06/2013 |
Software/
Informatics |
13-61 |
Complete |
IEC |
62443-2-1 Edition 1.0 2010-11 |
Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
| 05/26/2025 |
Software/
Informatics |
13-143 |
Complete |
AAMI |
TIR45:2023 |
Guidance on the use of AGILE practices in the development of medical device software |
| 08/06/2013 |
Software/
Informatics |
13-42 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| 08/21/2017 |
Software/
Informatics |
13-93 |
Complete |
ISO IEEE |
11073-10422:2017 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| IEEE |
Std 11073-10422-2016 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| 12/19/2022 |
Software/
Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
| 05/25/2026 |
Software/
Informatics |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 05/26/2025 |
Software/
Informatics |
13-142 |
Complete |
FIRST |
CVSS v3.1 |
Common Vulnerability Scoring System version 3.1 |
| 05/25/2026 |
Software/
Informatics |
13-157 |
Complete |
IEEE |
Std 11073-10207-2017 [Including Cor 1-2025] |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)] |
| 08/06/2013 |
Software/
Informatics |
13-60 |
Complete |
IEC |
TS 62443-1-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
| 12/19/2022 |
Software/
Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
| 12/19/2022 |
Software/
Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
| 05/25/2026 |
Software/
Informatics |
13-158 |
Complete |
IEEE |
Std 1752.1-2021 |
Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures |
| 12/19/2022 |
Software/
Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| 12/20/2021 |
Software/
Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| 12/19/2022 |
Software/
Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
| 12/19/2022 |
Software/
Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| 12/19/2022 |
Software/
Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
| 12/19/2022 |
Software/
Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
| 04/04/2016 |
Software/
Informatics |
13-81 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 10/19/2020 |
Software/
Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
| 05/26/2025 |
Software/
Informatics |
13-145 |
Complete |
IEEE |
Std 11073-10419:2023 |
Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump |
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