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BS EN 13532:2002

Current
Current

The latest, up-to-date edition.

General requirements for in vitro diagnostic medical devices for self-testing
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-08-2002

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design criteria
5 Markings and information supplied by the manufacturer
6 Performance evaluation
7 User verification
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

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

Committee
CH/212
DevelopmentNote
Supersedes 99/563274 DC (05/2002)
DocumentType
Standard
Pages
12
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
UNI EN 13532 : 2002 Identical
NBN EN 13532 : 2002 Identical
EN 13532:2002 Identical
DIN EN 13532:2002-08 Identical
NF EN 13532 : 2002 Identical
UNE-EN 13532:2002 Identical
NEN EN 13532 : 2002 Identical
SN EN 13532 : 2002 Identical
NS EN 13532 : 1ED 2002 Identical
I.S. EN 13532:2002 Identical

EN 1658 : 1996 REQUIREMENTS FOR MARKING OF IN VITRO DIAGNOSTIC INSTRUMENTS
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
EN 61326:1997/A3:2003
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

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Hardcopy - English
PDF - English
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