DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Apr 29, 2010

General information

60.60     Apr 29, 2010

DPS

DPS/KT 6

European Norm

11.040  

English  

Buying

Published

Language in which you want to receive the document.

Scope

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.

The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

NOW

PUBLISHED
SSH EN 60601-1:2006
60.60 Standard published
Apr 29, 2010

Related project

Adopted from EN 60601-1:2006

Adopted from IEC 60601-1 Ed. 3.0 b