Standard

NS-EN ISO 18113-1:2024

Jun 2024 Published

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Language English

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Abstract

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.This document does not address language requirements since that is the domain of national laws and regulations.This document does not apply to:a) IVD medical devices for performance evaluation (e.g. for investigational use only);b) shipping documents;c) material safety data sheets / Safety Data Sheets;d) marketing information (consistent with applicable legal requirements)..

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 18113-1:2011
Adopted from: EN ISO 18113-1:2024 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 18113-1:2011
Current product

Published

NS-EN ISO 18113-1:2024

NS-EN ISO 18113-1:2024

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