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I.S. EN ISO 23640:2015

I.S. EN ISO 23640:2015

Current

Current

The latest, up-to-date edition.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

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 General requirements
5 Procedures
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 98/79/EC
Bibliography

Pertains to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents.

DevelopmentNote
Supersedes I.S. EN 13640. (01/2012)
DocumentType
Standard
Pages
20
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 23640:2015 Identical
ISO 23640:2011 Identical

ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN 13640:2002 Stability testing of in vitro diagnostic reagents
CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
ISO 14971:2007 Medical devices Application of risk management to medical devices

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Hardcopy - English
PDF - English
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