Need help?

EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004) Standard

wave
Save  

  Keywords:

#programmable #can #controlled #system #electronic

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipmentIEC 60601-2-11:1997

  Purpose

This Particular Standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system (PES).

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 60601-2-11:1997"

  Reference

This standard superseed the "EN 60601-2-11:1997"

  Related Standards

EN ISO 22442-3:2007

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viru...

EN ISO 13485:2016

Medical devices Directive (93/42/EEC)

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

EN ISO 11607-2:2006

Medical devices Directive (93/42/EEC)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 11810-1:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient pro...

EN ISO 11810-2:2009

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-pro...

EN ISO 11990-1:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

  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 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004) 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