Need help?

EN 60601-1-2:2015 Standard

wave
Save  

  Keywords:

#systems #equipment #safety #essential #performance

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 5th of January 2022

  Description:

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60601-1-2:2014

  Purpose

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. Specifically, this collateral standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES of ME EQUIPMENT and ME SYSTEMS. Applicability of this collateral standard includes ME EQUIPMENT and ME SYSTEMS that have been found to have no ESSENTIAL PERFORMANCE. BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES shall be evaluated for all ME EQUIPMENT and ME SYSTEMS.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-1-2:2007"

Anyway is still possible use the "EN 60601-1-2:2007" until December 31st, 2018

  Related Standards

EN ISO 4135:2001

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

EN 60601-1-4:1996/A1:1999

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical sy...

EN 60601-1-11:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: R...

EN 60601-1-10:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: R...

EN 60601-1-8:2007/A11:2017

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

EN 60601-1-8:2007/AC:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 60601-1-2:2015 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0