BS EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects British-Adopted European Standard / 28-Mar-2003 / 16 pages ISBN: 0580415104

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Cross References:
EN 375:2001
EN ISO 9000:2000
98/79/EC
ISO 2859-1
ISO 2859-2
ISO 2859-3
ISO 3951

Keywords: Sampling methods; Approval testing; Acceptance (approval); Clinical investigation instruments; Statistics; Statistical methods of analysis; Medical equipment; Diagnosis (medical); Process control; Homogeneity; Certification (approval); Quality assurance

Product Code(s): 30085110,30085110

This product references:ISO 2859-1:1999 - Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-2:1985 - Sampling procedures for inspection by attributes - Part 2 : Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
BS EN 375:2001 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
BS EN ISO 9000:2000 - Quality management systems. Fundamentals and vocabulary

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