Back

EVS-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

General information
Withdrawn from 08.06.2015
Base Documents
IEC 60601-1-11:2010; EN 60601-1-11:2010
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Standard history
Status
Date
Type
Name
08.06.2015
Main
06.09.2010
Main
This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended by their manufacturer for use in the home healthcare environment, as defined in 3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a lay operator or by trained healthcare personnel. NOTE 1 home healthcare environment ME EQUIPMENT and ME SYSTEMS can also be intended for use in other environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use by emergency medical services or solely for use in professional healthcare facilities. NOTE 2 home healthcare environment ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.
*
*
*
PDF
21.60 € incl tax
Paper
21.60 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN 62366:2008

Medical devices – Application of usability engineering to medical devices
Withdrawn from 05.01.2016
Main

EVS-EN 60601-1-6:2010

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Valid from 07.06.2010
Main

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Withdrawn from 31.12.2020
Main

EVS-EN 60601-1-2:2007

Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Withdrawn from 03.12.2015