Back

EVS-EN 60601-1:2006/A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)

General information
Valid from 01.11.2021
Base Documents
EN 60601-1:2006/A2:2021; IEC 60601-1:2005/A2:2020
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.11.2021
Amendment
01.11.2021
Main + amendment
02.03.2016
Main + amendment
08.12.2006
Main + corrigendum
EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN 60601-1:2006/A2:2021 modifies the European standard EN 60601-1:2006.

Since the publication of EN 60601-1:2006/A11:2011, the IEC Subcommittee has been collecting issues from a variety of sources including comments from national committees and questions submitted. Those issues selected for inclusion on the final "short list" are addressed in this amendment.
*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN IEC 80001-1:2021

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Newest version Valid from 15.11.2021
Main

EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021
Amendment

EVS-EN 60601-1-2:2015/A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Valid from 01.04.2021
Main + amendment

EVS-EN 60601-1-2:2015+A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020)
Newest version Valid from 01.04.2021