Standard

ISO 18113-1:2022

Oct 2022 Current

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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). .

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Standard from ISO
Published: October 6 2022
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.10
International TC: ISO/TC 212

Product Relations

Revises: ISO 18113-1:2009

ISO 18113-1:2022

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ISO 18113-1:2022

ISO 18113-1:2009

Abstract

Products specifications

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Product life cycle

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ISO 18113-1:2022

ISO 18113-1:2009

Abstract

Products specifications

Product Relations

Product life cycle