I.S. EN 15986:2011
Current
The latest, up-to-date edition.
SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
Hardcopy , PDF
English
01-01-2011
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.
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Foreword
1 Scope
2 Terms and definitions
3 Requirements for usage
4 Symbol labelling phthalates
Annex A (informative) - Examples of uses of the symbol
given in this European Standard
Annex B (informative) - Use of the negation symbol
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Defines requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates.
| DocumentType |
Standard
|
| Pages |
15
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 15986:2011 | Identical |
| EN 80416-3:2002/A1:2011 | BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC 80416-3:2002+AMD1:2011 CSV | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 12264:2005 | Health informatics - Categorial structures for systems of concepts |
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