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07/30157023 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 15194 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
Available format(s)

Hardcopy , PDF

Superseded date

05-31-2009

Language(s)

English

Publisher

British Standards Institution

BS EN ISO 15194

Committee
CH/212
DocumentType
Draft
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO Guide 33:2015 Reference materials Good practice in using reference materials
ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO Guide 30:2015 Reference materials Selected terms and definitions
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
EN 980:2008 Symbols for use in the labelling of medical devices
ISO Guide 34:2009 General requirements for the competence of reference material producers

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Hardcopy - English
PDF - English

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