Skip to main content
Back

EVS-EN 62353:2008

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)

General information

Withdrawn from 02.07.2015
Base Documents
IEC 62353:2007; EN 62353:2008
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.07.2015
Main
07.03.2008
Main
This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such
equipment or systems, which comply with IEC 60601-1, before PUTTING INTO SERVICE, during
MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to
assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not
built to IEC 60601-1 these requirements may be used taking into account the safety standards
for the design and information in the instructions for use of that equipment.
This standard contains tables with allowable values relating to different editions of
IEC 60601-1. For the purpose of this standard, the application of measuring methods is
independent of the edition according to which the ME EQUIPMENT OR ME SYSTEM is designed.
This standard contains:
– "general requirements", which contain clauses of general concern, and
– "particular requirements", further clauses handling special types of ME EQUIPMENT or
ME SYSTEMS and applying in connection with the "General requirements".
NOTE 1 At this stage, there are no particular requirements.
This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other
equipment comply with the relevant standards for their design.
This standard does not define requirements for REPAIR, exchange of components and
MODIFICATION of ME EQUIPMENT or ME SYSTEMS.
NOTE 2 All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's
instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to
applicable requirements have to be assessed and verified.
This standard is also applicable to tests after REPAIR. The testing shall be defined according to
the extent of work performed and applicable guidance from the MANUFACTURER.
This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals
are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals.

Required fields are indicated with *

*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

IEC TR 60788:2004

Medical electrical equipment - Glossary of defined terms
Newest version Valid from 17.02.2004
Main

IEC TR 62296:2009

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Newest version Valid from 22.01.2009
Main

IEC TR 62348:2012

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
Newest version Valid from 12.12.2012
Main + corrigendum

EVS-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Withdrawn from 02.03.2016