|
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)
|
04/04/2016 |
Orthopedic |
11-303 |
Complete |
ASTM |
F3047M-15 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
06/27/2016 |
Dental/ ENT |
4-227 |
Complete |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-363 |
Complete |
ISO |
11810 Second edition 2015-12-15 |
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
06/27/2016 |
General Plastic Surgery/ General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
06/27/2016 |
Orthopedic |
11-307 |
Complete |
ASTM |
F2385-15 (Reapproved 2019) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
06/27/2016 |
Radiology |
12-295 |
Partial |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
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 |
07/26/2016 |
Biocompatibility |
2-174 |
Complete |
ISO |
10993-10 Third Edition 2010-08-01 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ANSI AAMI ISO |
10993-10:2010/(R)2014 |
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |