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09/30205582 DC : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2011

Superseded by

BS EN 15986:2011

Language(s)

English

€23.37
Excluding VAT

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Superseded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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