|
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)
|
12/21/2020 |
General I (QS/ RM) |
5-131 |
Complete |
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 |
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)] |
04/03/2023 |
General II (ES/ EMC) |
19-49 |
Complete |
IEC |
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
05/30/2022 |
General II (ES/ EMC) |
19-47 |
Complete |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)] |
05/30/2022 |
General II (ES/ EMC) |
19-46 |
Complete |
ANSI AAMI |
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] |
12/21/2020 |
General II (ES/ EMC) |
19-37 |
Complete |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
06/07/2021 |
Radiology |
12-336 |
Complete |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
12/21/2020 |
General II (ES/ EMC) |
19-39 |
Complete |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)] |
12/21/2020 |
General I (QS/ RM) |
5-132 |
Complete |
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 |
Partial |
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 |
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)] |
12/21/2020 |
General II (ES/ EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |