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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
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immediate downloadReleased: 2003-03-28
BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

BS EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

CURRENCY
LANGUAGE
English
Standard number:BS EN 13975:2003
Pages:16
Released:2003-03-28
ISBN:0 580 41510 4
Status:Standard
DESCRIPTION
This standard BS EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems
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.
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