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 1865-1:2010+A1:2015

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment

EN 60601-2-22:1996

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipmentIEC 606...

EN 60601-2-12:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilatorsIE...

EN 60601-2-13:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsI...

EN 60601-2-13:2006/A1:2007

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsI...

EN 60601-2-16:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofil...

  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