Committee
|
CTN 129 |
Development Note
|
Supersedes UNE EN 376. (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 |
EN 376 : 2002
|
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
CLSI GP10 A : 1ED 95(R2001)
|
ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS |
CLSI C28 A2 : 2ED 2000
|
HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
ISO 17593:2007
|
Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO 18113-5:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
ISO 15197:2013
|
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
EN 980:2008
|
Symbols for use in the labelling of medical devices |
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