|
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)
|
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-408 |
Partial |
ISO |
10555-1 Second edition 2013-06-15 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
05/29/2023 |
Cardiovascular |
3-185 |
Partial |
ANSI AAMI |
PC76:2021 |
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
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 |
05/29/2024 |
General II (ES/ EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
09/17/2018 |
General II (ES/ EMC) |
19-19 |
Partial |
IEC |
TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
04/04/2016 |
InVitro Diagnostics |
7-259 |
Partial |
CLSI |
GP23-A2 (Replaces GP23-A) |
Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
01/27/2015 |
InVitro Diagnostics |
7-250 |
Partial |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
04/04/2016 |
Tissue Engineering |
15-44 |
Partial |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
05/29/2024 |
Ophthalmic |
10-134 |
Partial |
ISO |
10943 Fourth edition 2023-01 |
Ophthalmic instruments - Indirect ophthalmoscopes |