ISO 20417:2021

Soveltamisala

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

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established

5.1 Units of measurement
5.2 Graphical information
5.3 Language and country identifiers
5.4 Dates
5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
5.10 Unique device identifier
5.11 Types of use/reuse
5.12 Sterile

6 Requirements for accompanying information

6.1 Requirements for information to be supplied on the label
6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.6 Requirements for information in the instructions for use and technical description

7 Other information that is required to be supplied with the medical device or accessory

7.1 Importer
7.2 Distributor
7.3 Repackaging
7.4 Translation
7.5 Regulatory identification

Annex A Particular guidance and rationale (informative)
Annex B Example test method for assessing clearly legible requirements (informative)
Annex C Example test method for assessing durability (informative)
Annex D Cross reference between the document and the requirements considered (informative)
Annex E Reference to the IMDRF essential principles and labelling guidances (informative)
Annex F Reference to the essential principles (informative)
Annex G Reference to the general safety and performance requirements for medical devices (informative)
Annex H Reference to the general safety and performance requirements for IVD medical devices (informative)
Annex I Terminology — Alphabetized index of defined terms (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established

5.1 Units of measurement
5.2 Graphical information
5.3 Language and country identifiers
5.4 Dates
5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
5.10 Unique device identifier
5.11 Types of use/reuse
5.12 Sterile

6 Requirements for accompanying information

6.1 Requirements for information to be supplied on the label
6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.6 Requirements for information in the instructions for use and technical description

7 Other information that is required to be supplied with the medical device or accessory

7.1 Importer
7.2 Distributor
7.3 Repackaging
7.4 Translation
7.5 Regulatory identification

Annex A Particular guidance and rationale (informative)
Annex B Example test method for assessing clearly legible requirements (informative)
Annex C Example test method for assessing durability (informative)
Annex D Cross reference between the document and the requirements considered (informative)
Annex E Reference to the IMDRF essential principles and labelling guidances (informative)
Annex F Reference to the essential principles (informative)
Annex G Reference to the general safety and performance requirements for medical devices (informative)
Annex H Reference to the general safety and performance requirements for IVD medical devices (informative)
Annex I Terminology — Alphabetized index of defined terms (informative)

Bibliography

Tuoteryhmä(t)

11.040.01 Medical equipment in general »

Sidokset

Velvoittavat viittaukset

IEC 60417 (database), Graphical symbols for use on equipment
IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of the usability engineering process to medical devices
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

Tekninen komitea

ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices »

Vahvistuspäivä

13.04.2021

Julkaisupäivä

13.04.2021

Painos

2021

Sivumäärä

72

Julkaisun kieli

englanti