BS EN 13532:2002
Current
The latest, up-to-date edition.
General requirements for in vitro diagnostic medical devices for self-testing
Hardcopy , PDF
English
08-05-2002
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 99/563274 DC (05/2002)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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 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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