BS EN 13975:2003

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

More details

Download

PDF AVAILABLE FORMATS IMMEDIATE DOWNLOAD
$68.64

$156.00

(price reduced by 56 %)



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

People Who Bought This Also Bought:
BS EN 13612:2002- Performance evaluation of in vitro diagnostic medical devicesBS EN 13640:2002- Stability testing of in vitro diagnostic reagentsBS EN 13641:2002- Elimination or reduction of risk of infection related to in vitro diagnostic reagentsBS EN 980:2008- Symbols for use in the labelling of medical devicesBS EN 375:2001- Information supplied by the manufacturer with in vitro diagnostic reagents for professional useBS EN ISO 18113-3:2009- In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional useBS EN 14136:2004- Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination proceduresBS EN 62366:2008- Medical devices. Application of usability engineering to medical devicesBS EN 1041:1998- Information supplied by the manufacturer with medical devicesBS EN ISO 17511:2003- In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials

Contact us