BS EN 13532:2002 - General requirements for in vitro diagnostic medical devices for self-testing – BSI British Standards

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BS EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

Status : Current, Under review   Published : May 2002

Format
PDF

Format
HARDCOPY



BS EN 13532:2002 specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.

This European standard does not address medical aspects of IVD MDs for self-testing.




Standard NumberBS EN 13532:2002
TitleGeneral requirements for in vitro diagnostic medical devices for self-testing
StatusCurrent, Under review
Publication Date08 May 2002
Cross ReferencesEN 1441, EN ISO 14971, ISO 14971:2000, 98/79/EC, EN 376, EN 592, EN 1658, EN 13612, EN 61010-1:2001, IEC 61010-1:2001, EN 61326, IEC 61326:1997
International RelationshipsEN 13532:2002
Draft Superseded By99/563274 DC
DescriptorsClinical investigation instruments, Medical equipment, Diagnostic testing, Diagnosis (medical), Personal health, Health and safety requirements
ICS11.100.10
Title in FrenchExigences generales relatives aux dispositifs medicaux de diagnostic in vitro destines a des auto-diagnostics
Title in GermanAllgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung
CommitteeCH/212
ISBN0 580 39682 7
PublisherBSI
FormatA4
DeliveryYes
Pages12
File Size219 KB
Price£106.00


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