Need help?

EN 60601-2-28:2010 Standard

wave
Save  

  Keywords:

#subclause #clause #equipment #intended #systems

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosisIEC 60601-2-28:2010

  Purpose

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: – hereafter referred to as ME EQUIPMENT; – intended for medical diagnosis and imaging. 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 Mem SYSTEMS, as relevant.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-2-28:1993"

Anyway is still possible use the "EN 60601-2-28:1993" until April 1st, 2013

  Related Standards

EN ISO 22442-1:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 10651-2:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 10555-1:2009

Medical devices Directive (93/42/EEC)

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN ISO 10535:2006

Medical devices Directive (93/42/EEC)

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

  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 60601-2-28:2010 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