Committee
|
CTN 129 |
Development Note
|
Supersedes UNE EN 375. (01/2013) |
Document Type
|
Standard |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
Asociacion Espanola de Normalizacion
|
Status
|
Current |
Supersedes
|
|
ISO 18113-1:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
CLSI GP10 A : 1ED 95(R2001)
|
ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS |
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 |
CLSI C28 A2 : 2ED 2000
|
HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
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 |
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
EN 980:2008
|
Symbols for use in the labelling of medical devices |
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