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BS EN ISO 20417:2021:2022 Edition

BS EN ISO 20417:2021:2022 Edition

$215.11

Medical devices. Information to be supplied by the manufacturer

Published By Publication Date Number of Pages
BSI 2022 86
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NOTE 1

There is guidance or rationale for this Clause contained in Clause A.2.

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.

NOTE 2

Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
17 4 General considerations
18 5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information
19 5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates
20 5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
21 5.10 Unique device identifier
5.11 Types of use/reuse
5.12 Sterile
22 6 Requirements for accompanying information
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label
6.1.2 Identification of the manufacturer
23 6.1.3 Identification of the medical device or accessory
25 6.1.4 Other label requirements
26 6.1.5 Consult instructions for use
27 6.1.6 Safety signs
28 6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
29 6.5 Information to be provided on the packaging
6.5.1 General information
30 6.5.2 Packaging for the lay user
31 6.5.3 Special conditions indicated on the packaging
32 6.6 Requirements for information in the instructions for use and technical description
6.6.1 General
33 6.6.2 Requirements for instructions for use
38 6.6.3 Additional requirements for the instructions for use for a lay user
6.6.4 Requirements for technical description
41 6.6.5 Requirements for e-documentation
7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor
42 7.3 Repackaging
7.4 Translation
7.5 Regulatory identification
44 Annex A (informative) Particular guidance and rationale
47 Annex B (informative) Example test method for assessing clearly legible requirements
48 Annex C (informative) Example test method for assessing durability
49 Annex D (informative) Cross reference between the document and the requirements considered
65 Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
69 Annex F (informative) Reference to the essential principles
73 Annex G (informative) Reference to the general safety and performance requirements for medical devices
77 Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices
81 Annex I (informative) Terminology — Alphabetized index of defined terms
83 Bibliography

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BS EN ISO 20417:2021
$215.11