Standard

NS-EN 13532:2002

Jul 2002 Published

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Language English

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Abstract

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.

Document information

Standard from SN
Published: 10 July 2002
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.100
ICS 11.100.10
National Committee SN/K 116

Legal references

EU law: 98/79/EC

Product Relations

Refers: NEK EN 61010-1:2001
Adopted from: EN 13532:2002 , 0

NS-EN 13532:2002

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Abstract

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