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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 EU verification by a notified body.
Two different provisions are addressed:
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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