I.S. EN ISO 20417:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Hardcopy , PDF
17-01-2022
English
28-05-2021
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.
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 A (informative) Particular guidance and rationale
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
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