BS EN ISO 18113-1:2024

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In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – Terms, definitions, and general requirements

Published By	Publication Date	Number of Pages
BSI	2024	68

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Categories: 11.100.10 - In vitro diagnostic test systems, BSI

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Description

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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PDF Pages	PDF Title
2	undefined
7	Annex ZA (informative)Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
11	Foreword
12	Introduction
14	1 Scope 2 Normative references 3 Terms and definitions
15	3.1 General terms and definitions for use with in vitro diagnostic medical devices
35	3.2 Performance characteristic terms and definitions
53	4 General requirements for information supplied by the manufacturer 4.1 General
54	4.2 Language 4.3 Symbols and identification colours 4.4 Values and nomenclature
55	4.5 Microbiological state 4.6 Instructions for use
56	4.7 Changes to the IVD medical device 4.8 Disclosure of residual risks 4.9 Identification of components 4.10 Assistance
57	Annex A (informative) Performance characteristics of IVD medical devices
63	Bibliography

Additional information

Status	Definitive
Pages	68
Publication Date	2024-06-12
ISBN	978 0 539 13478 0
Standard Number	BS EN ISO 18113-1:2024
Title	In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – Terms, definitions, and general requirements
Identical National Standard Of	EN ISO 18113-1, ISO 18113-1
Replaces	BS EN ISO 18113-1:2011
Descriptors	Definitions, Reagent solutions, Clinical laboratory equipment, Product information, Measurement, Labelling (process), Instructions for use, Clinical investigation instruments, Diagnostic reagents, Labels, Diagnosis (medical), Medical equipment
Publisher	BSI
Committee	CH/212
ICS Codes	11.100.10 - In vitro diagnostic test systems

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BS EN ISO 18113-1:2024

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