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Norm
ÖNORM EN 13975
Issue date: 2003 11 01
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro
diagnostic medical devices, which require EC verification by...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 18 Pages
Language:
German
| English
| Download GER/ENG
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This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro
diagnostic medical devices, which require EC 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.
ÖNORM EN 13975
2003 11 01
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical...
Norm
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Norm
ISO 2859-1:1999
Issue date :
1999 11 18
Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
Norm
ISO 2859-2:1985
Issue date :
1985 08 29
Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
Draft
ISO/DIS 2859-2
Issue date :
2007 12 07
Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limited quality (LQ) for isolated lot inspection
Norm
ISO 2859-3:2005
Issue date :
2005 05 27
Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures
Norm
ISO 2859-2:2020
Issue date :
2020 02 13
Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
Norm
ISO 2859-3:2005
Issue date :
2005 05 27
Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures
Norm
ISO 3951:1989
Issue date :
1989 09 14
Sampling procedures and charts for inspection by variables for percent nonconforming