BS 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
31-03-2011
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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.
| Committee |
CH/210/3
|
| DevelopmentNote |
Supersedes 09/30205582 DC. (03/2011)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by AnnexI of Directive 93/42/EEC Section7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN980 and EN1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
| 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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