Comment Closes On
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Committee
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CH/212 |
Document Type
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Draft |
ISBN
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Pages
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Published
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Publisher
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British Standards Institution
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Status
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Superseded |
Superseded By
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ISO 18113-1:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
ISO 15198:2004
|
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
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 17511:2003
|
In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
ISO 8601:2004
|
Data elements and interchange formats Information interchange Representation of dates and times |
EN 375 : 2001
|
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO 18113-3:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
EN 980:2008
|
Symbols for use in the labelling of medical devices |
ISO 15223:2000
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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