Recognized Consensus Standards: Medical Devices
-
|
351 to 400 of 1554 Results
|
Results per Page |
|
Date of
Entry ![Sort by Date [Old to new]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon} ![Sort by Date [New to old]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
|
Specialty Task
Group Area
|
Recognition
Number
|
Extent of
Recognition
|
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 12/20/2021 | General I (QS/ RM) |
5-134 | Complete | ISO | 15223-1 Fourth edition 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 12/19/2022 | General I (QS/ RM) |
5-135 | Complete | ISO | 20417 First edition 2021-04 Corrected version 2021-12 | Medical devices - Information to be supplied by the manufacturer |
| 12/19/2022 | General I (QS/ RM) |
5-136 | Complete | ASTM | D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 12/19/2022 | General I (QS/ RM) |
5-137 | Complete | IEC | TR 60878 Ed. 4.0 2022-11 | Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
| 12/19/2022 | General I (QS/ RM) |
5-138 | Complete | AAMI | TIR66: 2017/(R)2020 | Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 12/19/2022 | General I (QS/ RM) |
5-139 | Complete | ISO | 18250-3 First edition 2018-06 | Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 12/19/2022 | General I (QS/ RM) |
5-140 | Complete | ASME | V&V 10-2019 | Standard for Verification and Validation in Computational Solid Mechanics |
| 12/19/2022 | General I (QS/ RM) |
5-141 | Complete | ASME | V&V 20-2009 (R2021) | Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 05/29/2024 | General I (QS/ RM) |
5-142 | Complete | ISO | 780 Fifth edition 2015-12-01 | Packaging - Distribution packaging - Graphical symbols for handling and storage of packages |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-70 | Complete | ASTM | E825-98 (Reapproved 2016) | Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-110 | Complete | ASTM | F1441-03 (Reapproved 2014) | Standard Specification for Soft-Tissue Expander Devices |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-117 | Complete | ASTM | F2172-02 (Reapproved 2011) | Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/15/2013 | General Plastic Surgery/ General Hospital |
6-122 | Complete | ISO | 8536-5 Second edition 2004-02-01 | Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 09/17/2018 | General Plastic Surgery/ General Hospital |
6-123 | Complete | ASTM | E667-98 (Reapproved 2017) | Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-124 | Complete | ASTM | E1104-98 (Reapproved 2016) | Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-125 | Complete | ASTM | E1965-98 (Reapproved 2016) | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-147 | Complete | ASTM | D6978-05(2023) | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-177 | Complete | ASTM | E1112-00(2018) | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-178 | Partial | ASTM | D6124-06(2022) | Standard Test Method for Residual Powder on Medical Gloves |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-179 | Complete | ISO | 21649 First edition 2006-06-01 | Needle-free injectors for medical use -- Requirements and test methods |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-185 | Complete | ASTM | F881-94 (Reapproved 2014) | Standard Specification for Silicone Elastomer Facial Implants |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-200 | Complete | ASTM | E1061-01(2022) | Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-214 | Complete | ASTM | D6355-07(2022) | Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| 03/18/2009 | General Plastic Surgery/ General Hospital |
6-215 | Complete | ASTM | F2132-01 (Reapproved 2008)e1 | Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-216 | Complete | ISO | 8536-7 Third edition 2009-01-15 | Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-240 | Complete | ISO | 8536-3 Third edition 2009-06-01 | Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-242 | Complete | ISO | 8536-2 Third edition 2010-03-15 | Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-253 | Complete | ISO | 10535 Second edition 2006-12-15 | Hoists for the transfer of disabled persons - Requirements and test methods |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-268 | Complete | ASTM | F921-10 (Reapproved 2018) | Standard Terminology Relating to Hemostatic Forceps |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-269 | Complete | ASTM | F1078-10 (Reapproved 2018) | Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-270 | Complete | ASTM | F1840-10 (Reapproved 2016) | Standard Terminology for Surgical Suture Needles |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-271 | Complete | ASTM | F1874-98 (Reapproved 2011) | Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-272 | Complete | ASTM | F2062-00 (Reapproved 2018) | Standard Specification for Square Drive Interconnections on Surgical Instruments |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-273 | Complete | ISO | 23908 First edition 2011-06-11 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-276 | Complete | ISO | 8536-1 Fourth edition 2011-09-01 | Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-278 | Complete | ISO | 11040-5 Third edition 2012-02-15 | Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-295 | Complete | AAMI ANSI | BF7:2012 | Blood transfusion microfilters |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-296 | Complete | ANSI AAMI | PB70:2012 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-303 | Complete | ISO | 10555-5 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-305 | Complete | ISO | 10555-3 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-306 | Complete | ASTM | F1671/F1671M-13 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-321 | Complete | IEC | 60601-2-52 Edition 1.0 2009-12 | Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-322 | Complete | ISO | 10555-4 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 01/14/2019 | General Plastic Surgery/ General Hospital |
6-338 | Complete | ASTM | D7866-14 | Standard Specification for Radiation Attenuating Protective Gloves |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-353 | Complete | ASTM | F2051-00 (Reapproved 2014) | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-354 | Complete | ASTM | D7907-14 (Reapproved 2019) | Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-355 | Complete | ASTM | D3772-15(2021) | Standard Specification for Industrial Rubber Finger Cots |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-356 | Complete | ASTM | D5712-15(2020) | Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-357 | Complete | ISO | 10555-6 First edition 2015-04-15 | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports |
| 04/04/2016 | General Plastic Surgery/ General Hospital |
6-358 | Partial | ISO | 8536-8 Second Edition 2015-06-15 | Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus |
-
