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PREN 15986 : DRAFT 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

Superseded date

01-03-2011

Published date

12-01-2013

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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

Describes requirements for the labelling of a device or parts of device containing phthalates that require labelling by Annex I of Directive 93/42/EEC section 7.5.

Committee
TC 3
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded

Standards Relationship
DIN EN 15986:2011-05 Identical
09/30205582 DC : 0 Identical

PREN ISO 3826-1 : DRAFT 2010 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
10/30233840 DC : 0 BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS

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