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DIN EN 15986:2011-05

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2011

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen
  4.1 Anforderungen an den Gebrauch
5 Symbol für die Kennzeichnung von Phthalaten
  5.1 Allgemeines
  5.2 Symbol für "ENTHÄLT ODER ANWESENHEIT
      VON PHTHALATE"
Anhang A (normativ) Beispiele für den Gebrauch der in
          dieser Norm angegebenen Symbole
Anhang B (informativ) Verwendung des Aufhebungssymbols
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG über
          Medizinprodukte

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 Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph.

DevelopmentNote
Available with CD-ROM. (05/2011)
DocumentType
Standard
Pages
14
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
EN 15986:2011 Identical
PREN 15986 : DRAFT 2009 Identical

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