I.S. EN ISO 15223-1:2021/A1:2025
Current
The latest, up-to-date edition.
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/Amd 1:2025)
Hardcopy , PDF
English
13-11-2025
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.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirement
5 Symbols
Annex A (informative) Guidance and examples of symbol use, including multiple symbols.
Annex B (informative) Use of general prohibition symbol and negation symbol
Bibliography
This document specifies symbols used to express information supplied for a medical device.
| DocumentType |
Standard
|
| Pages |
74
|
| ProductNote |
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 15223-1:2021 | Identical |
| ISO 15223-1:2021 | Identical |
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