EN 60601-1-11:2010

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Publication date:   Sep 16, 2010

General information

99.60 Withdrawal effective   Dec 31, 2018

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.020.10   Health care services in general | 11.040.01   Medical equipment in general

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Scope

IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 60601-1-11:2010
99.60 Withdrawal effective
Dec 31, 2018

REVISED BY

PUBLISHED
EN 60601-1-11:2015