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I.S. EN ISO 22870:2016

I.S. EN ISO 22870:2016

Current

Current

The latest, up-to-date edition.

POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

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.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Bibliography

Provides specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.

DocumentType
Standard
Pages
28
PublisherName
National Standards Authority of Ireland
Status
Current
SupersededBy
Supersedes

ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
CLSI POCT7 A : 1ED 2010 QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE

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Hardcopy - English
PDF - English
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