Comment Closes On
|
|
Committee
|
CH/212 |
Document Type
|
Draft |
ISBN
|
|
Pages
|
|
Published
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|
Publisher
|
British Standards Institution
|
Status
|
Superseded |
Superseded By
|
|
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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