Skip to main content
Back

EVS-EN 60601-1:2006/A12:2014

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

General information

Valid from 07.11.2014
Base Documents
EN 60601-1:2006/A12:2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
07.11.2014
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. EN 60601-1:2006/A1:2013 modifies the European standard EN 60601-1:2006. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— the relationship between EN 60601-1 and the essential requirements of EU Directive 90/385/EEC on active implantable medical devices

Required fields are indicated with *

*
*
*
PDF
12.20 € incl tax
Paper
12.20 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + corrigendum

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
Valid from 08.12.2006
Amendment

EVS-EN 60601-1:2006/A1:2013

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Valid from 14.11.2013
Main

EVS-EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Valid from 03.12.2015
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016