Standard

NS-EN ISO 18113-3:2024

Jun 2024 Published

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Abstract

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.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 self-testing.

Document information

Standard from SN , 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, 2017/746

Product Relations

Refers: IEC 61326-2-6:2020 RLV
Refers: IEC 61326-2-6:2020 ED3
Refers: IEC 62366-1:2015+AMD1:2020 CSV
Refers: IEC 61010-2-101:2018 RLV
Refers: IEC 61010-2-101:2018 ED3
Refers: IEC 61010-1:2010+AMD1:2016 CSV
Refers: IEC 62366-1:2015 ED1
Replaces: NS-EN ISO 18113-3:2011
Refers: IEC 61010-1:2010 ED3
Adopted from: EN ISO 18113-3:2024 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 18113-3:2011
Current product

Published

NS-EN ISO 18113-3:2024

NS-EN ISO 18113-3:2024

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