09/30205582 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
Hardcopy , PDF
English
31-03-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Requirements for usage
4.1.1 If phthalates which are classified as carcinogenic,
mutagenic or toxic to reproduction of category
1 or 2 in accordance with table 3.2 of Annex VI of
Regulation 1272/2008, are part of the formulation
and the device is:
4.1.2 The meaning of the symbol in Clause 5.2 shall
be explained in the information supplied by the
manufacturer
5 Symbol labelling phthalates
5.1 General
5.1.1 This Clause contains a symbol that neither has
been published in previous editions of the
European Standard EN 980 nor ISO standard
ISO 15223-1 and may be new or unfamiliar to
users
5.2 Symbol for "CONTAINS OR PRESENCE OF PHTHALATE"
Annex A (normative) - Examples of uses of symbols given
in this standard
A.1 Examples of use of symbol for "contains or presence
of phthalate": bis (2-ethylhexyl) phthalate (DEHP)
A.2 Examples of use of symbol for "contains or presence
of phthalate": dibutyl phthalate (DBP)
A.3 Examples of use of symbol for "contains or presence
of phthalate": benzyl butyl phthalate (BBP)
A.4 Examples of use of symbol for "contains or presence
of phthalate": combination of bis (2-ethylhexyl)
phthalate (DEHP); benzyl butyl phthalate (BBP) and
dibutyl phthalate (DBP)
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
BS EN 15986
| Committee |
CH/210/3
|
| DocumentType |
Draft
|
| Pages |
13
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 15986 : DRAFT 2009 | Identical |
| EN ISO 15225:2016 | Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| 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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