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BS EN 13975:2003

Current
Current

The latest, up-to-date edition.

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-28-2003

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures
Annex A (informative) General notes
Annex ZA (informative) Clauses of this European Standard
         addressing requirements of EU Directives
Bibliography

Covers sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body.

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers\' product certification and production quality systems.

Committee
CH/212
DevelopmentNote
Supersedes 00/564528 DC. (04/2003)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
UNE-EN 13975:2003 Identical
DIN EN 13975:2003-11 Identical
EN 13975:2003 Identical
NBN EN 13975 : 2003 Identical
NS EN 13975 : 1ED 2003 Identical
UNI EN 13975 : 2003 Identical
SN EN 13975 : 2003 Identical
I.S. EN 13975:2003 Identical
NF EN 13975 : 2003 Identical
NEN EN 13975 : 2003 Identical

ISO 2859-3:2005 Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures
ISO 3951:1989 Sampling procedures and charts for inspection by variables for percent nonconforming
ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

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Hardcopy - English
PDF - English
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