Standard

NS-EN ISO 18113-5:2024

Jun 2024 Published

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Language English

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Abstract

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.This document can also be applicable to accessories.This document does not apply to:a) instructions for instrument servicing or repair;b) IVD reagents, including calibrators and control materials for use in control of the reagent;c) IVD instruments for professional use.

Document information

Standard from SN
Published: 26 June 2024
Edition: 2024-06
Version: 1
Document type: NAT
ISBN:

ICS 11.100.10
National Committee SN/K 116

Legal references

EU law: 2017/746

Product Relations

Replaces: NS-EN ISO 18113-5:2011
Adopted from: EN ISO 18113-5:2024 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 18113-5:2011
Current product

Published

NS-EN ISO 18113-5:2024

NS-EN ISO 18113-5:2024

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