Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
651 to 700 of 1554 Results
 < 
 9 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 17 
 18 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
Standards
Developing
Organization

Standard Designation
Number and Date
 

Standard Title
(click for recognition information)
 
12/20/2021 Ophthalmic 10-127 Complete ANSI Z80.21-2020 American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
06/07/2021 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)]
06/07/2021 Ophthalmic 10-125 Partial ISO 11979-7 Fourth edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
06/07/2021 Ophthalmic 10-124 Complete ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
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
06/07/2021 Ophthalmic 10-122 Partial ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
12/21/2020 Ophthalmic 10-121 Complete ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
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
12/21/2020 Ophthalmic 10-119 Complete ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
07/15/2019 Ophthalmic 10-118 Complete ANSI Z80.38-2017 (R2021) American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
07/15/2019 Ophthalmic 10-117 Complete ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
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 10-115 Complete ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
01/14/2019 Ophthalmic 10-114 Complete ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
09/17/2018 Ophthalmic 10-113 Complete ANSI Z80.30-2018 (R2023) American National Standard for Ophthalmics - Toric 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
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
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
01/14/2019 Ophthalmic 10-108 Partial ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
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
06/07/2018 Ophthalmic 10-106 Complete ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-105 Complete ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
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
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
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
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 10-99 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
08/14/2015 Ophthalmic 10-98 Complete ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015 Ophthalmic 10-97 Complete ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
08/14/2015 Ophthalmic 10-96 Partial ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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
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
01/14/2019 Ophthalmic 10-93 Partial ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
07/15/2019 Ophthalmic 10-89 Partial ANSI Z80.7-2013 (R2023) American National Standard for Ophthalmic Optics - Intraocular Lenses
01/14/2019 Ophthalmic 10-86 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
09/17/2018 Ophthalmic 10-84 Complete ANSI Z80.11-2012 (R2022) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
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
08/06/2013 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
01/14/2019 Ophthalmic 10-74 Partial ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
03/16/2012 Ophthalmic 10-70 Complete ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
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
08/02/2011 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 10-56 Partial ANSI Z80.12-2007 (R2022) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
12/19/2007 Ophthalmic 10-39 Complete ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
12/18/2023 ObGyn/
Gastroenterology/
Urology		 9-150 Complete ISO 7439 Fourth edition 2023-04 Copper-bearing contraceptive intrauterine devices - Requirements and tests
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-148 Complete ISO CIE 11664-6 Second edition 2022-08 Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-147 Complete ISO CIE 11664-2 First edition 2022-08 Colorimetry - Part 2: CIE standard illuminants
 
 < 
 9 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 17 
 18 
 > 
 
-
-