SR EN ISO 18113-1:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

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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General information

Status : Valid
Approval date : 12/31/2024
Number of pages : 70
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 18113-1:2012
Normative reference SR EN ISO 13485:2016
Normative reference SR EN ISO 13485:2016/AC:2018
Normative reference SR EN ISO 13485:2016/A11:2021
Normative reference SR EN ISO 14971:2020
Normative reference SR EN ISO 14971:2020/A11:2022
Normative reference SR EN ISO 15223-1:2021
Normative reference SR EN 62366-1:2015
Normative reference SR EN 62366-1:2015/A1:2020
Normative reference SR EN 62366-1:2015/AC:2016