BS EN ISO 18113-3:2024

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In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – In vitro diagnostic instruments for professional use

Published By	Publication Date	Number of Pages
BSI	2024	26

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Categories: 11.100.10 - In vitro diagnostic test systems, BSI

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Description

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.

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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
12	Foreword
13	Introduction
15	1 Scope 2 Normative references 3 Terms and definitions
16	4 Essential requirements 5 Labels and marking 5.1 General 5.2 Identification of the IVD instrument 5.2.1 IVD instrument name 5.2.2 Serial number 5.2.3 In vitro diagnostic use
17	5.2.4 Unique device identifier (UDI) 6 Elements of the instructions for use
18	7 Content of the instructions for use 7.1 Manufacturer 7.2 Identification of the IVD instrument 7.2.1 IVD instrument name 7.2.2 Module and software identification
19	7.3 Intended use/Intended purpose 7.4 Storage and handling 7.5 Warnings and precautions and/or measures to be taken and limitations of use regarding the instrument
20	7.6 Instrument installation 7.6.1 General 7.6.2 Action upon delivery 7.6.3 Site preparation prior to installation 7.6.4 Bringing into operation
21	7.7 Theory of operation 7.8 Functions 7.9 Limitations 7.10 Preparation prior to operation 7.11 Operating procedure
22	7.12 Control procedure 7.13 Calculation of examination results 7.14 Special functions 7.15 Emergency samples 7.16 Shut-down procedure 7.17 Disposal information
23	7.18 Maintenance 7.19 Troubleshooting 7.20 Document control
24	Bibliography

Additional information

Status	Definitive
Pages	26
Publication Date	2024-06-12
ISBN	978 0 539 13480 3
Standard Number	BS EN ISO 18113-3:2024
Title	In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – In vitro diagnostic instruments for professional use
Identical National Standard Of	EN ISO 18113-3, ISO 18113-3
Replaces	BS EN ISO 18113-3:2011
Descriptors	Health service personnel, Instructions for use, Clinical laboratory equipment, Medical equipment, Product information, Labelling (process), Labels, Clinical investigation instruments, Diagnosis (medical)
Publisher	BSI
Committee	CH/212
ICS Codes	11.100.10 - In vitro diagnostic test systems

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BS EN ISO 18113-3:2024

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