Recognized Consensus Standards: Medical Devices
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Results per Page |
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) |
03/18/2009 | InVitro Diagnostics | 7-180 | Complete | CLSI | M34-A (Replaces M24-P) | Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
08/20/2012 | General Plastic Surgery/ General Hospital |
6-278 | Complete | ISO | 11040-5 Third edition 2012-02-15 | Prefilled syringes - Part 5: Plunger stoppers for injectables |
03/16/2012 | Tissue Engineering | 15-31 | Complete | ASTM | F2312-11 (Reapproved 2020) | Standard Terminology Relating to Tissue Engineered Medical Products |
01/15/2013 | Sterility | 14-215 | Complete | AOAC | 6.2.05:2006 | Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
04/04/2016 | Materials | 8-399 | Complete | ASTM | F90-14 | Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
01/27/2015 | General I (QS/ RM) |
5-62 | Complete | ANSI ASQ | Z1.4-2003 (R2018) | Sampling Procedures and Tables for Inspection by Attributes |
01/30/2014 | General Plastic Surgery/ General Hospital |
6-273 | Complete | ISO | 23908 First edition 2011-06-11 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
08/06/2013 | Software/ Informatics |
13-52 | Complete | ISO IEEE | 11073-10408 First edition 2010-05-01 | Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
06/27/2016 | Materials | 8-427 | Complete | ASTM | F1185-03 (Reapproved 2014) | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
12/23/2016 | Physical Medicine | 16-199 | Complete | ISO | 7176-28 First edition 2012-10-1 | Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |