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I.S. EN ISO 19001:2013

Current
Current

The latest, up-to-date edition.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for information supplied by the
  manufacturer
Annex A (informative) - Examples of information
        supplied by the manufacturer with reagents
        commonly used in biological staining
        procedures
Bibliography

Defines requirements for information supplied by the manufacturer with reagents used in staining in biology.

DevelopmentNote
Supersedes I.S. EN 12376. (05/2013)
DocumentType
Standard
Pages
29
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 19001:2013 Identical
ISO 19001:2013 Identical

ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 80000-1:2009 Quantities and units — Part 1: General
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

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