|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
06/07/2021 |
Radiology |
12-340 |
IEC |
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
12/21/2020 |
Anesthesiology |
1-148 |
ISO |
80601-2-69 Second edition 2020-11 |
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment |
12/21/2020 |
General I (QS/ RM) |
5-131 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)] |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
12/21/2020 |
General I (QS/ RM) |
5-132 |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
12/21/2020 |
General II (ES/ EMC) |
19-36 |
ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |