Need help?

EN 60601-2-29:2008 Standard

wave
Save  

  Keywords:

#equipment #standard #systems #clause #subclause

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulatorsIEC 60601-2-29:2008

  Purpose

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of RADIOTHERAPY SIMULATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-2-29:1999"

Anyway is still possible use the "EN 60601-2-29:1999" until November 1st, 2011

  Related Standards

EN 1640:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Equipment

EN 14139:2010

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Specifications for ready-to-wear spectacles

EN ISO 15002:2008

Medical devices Directive (93/42/EEC)

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

EN ISO 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 14971:2012

Medical devices Directive (93/42/EEC)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 14937:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

  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 60601-2-29:2008 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