SS-EN-13975 › Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
SS-EN-13975
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EDITION 1
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CURRENT
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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.
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11.100.10 (In vitro diagnostic test systems)
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Designation Name
SS-EN 13975
Revision Level
EDITION 1
Status
Current
Publication Date
Aug. 1, 2003
Language(s)
English
Page Count
13
International Equivalent
EN 13975:2003(IDT)