I.S. EN ISO 15223-1:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
Hardcopy , PDF
English
01-01-2016
11-07-2020
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.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Symbols
Annex A (informative) - Examples
Annex B (informative) - Use of general prohibition
symbol and negation symbol
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC [OJ L 169] on Medical Devices
Annex ZB (informative) - Relationship between this
European standard and the essential requirements
of Directive 90/385/EEC [OJ L 189] aimed to be covered
Annex ZC (informative) - Relationship between this
European standard and the essential requirements of
Directive 98/79/EC [OJ L 331] aimed to be covered
Defines requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
| Committee |
TC 210
|
| DevelopmentNote |
Supersedes I.S. EN 980. (07/2012) 2016 Edition Incorporates Corrigendum. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
50
|
| ProductNote |
CORRECTED VERSION IS NOW AVAILABLE FOR THIS STANDARD 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 |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 15223-1:2016 | Identical |
| EN ISO 15223-1:2016 | Identical |
| BS EN ISO 15223-1:2016 | Equivalent |
A newer version of this standard is available.
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