I.S. EN ISO 20417:2021&LC:2021
Current
The latest, up-to-date edition.
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
Hardcopy , PDF
English
14-01-2022
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established
6 Requirements for accompanying information
7 Other information that is required to be supplied with the medical device or
accessory
Annex B (informative) Example test method for assessing clearly legible requirements
Annex C (informative) Example test method for assessing durability
Annex D (informative) Cross reference between the document and the requirements
considered
Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
Annex F (informative) Reference to the essential principles
Annex G (informative) Reference to the general safety and performance requirements for
medical devices
Annex H (informative) Reference to the general safety and performance requirements for
IVD medical devices
Annex I (informative) Terminology — Alphabetized index of defined terms
Bibliography
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.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| Pages |
92
|
| ProductNote |
This standard is also refer to : ISO/IEC/TR 20007 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 20417:2021 | Identical |
| ISO 20417:2021 | Identical |
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