I.S. EN ISO 18153:2003
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES FOR CATALYTIC CONCENTRATION OF ENZYMES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
Hardcopy , PDF
English
01-01-2003
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Metrological traceability chain and calibration hierarchy
4.1 Principles
4.2 Structure
5 Validation of metrologically traceable calibration
5.1 Principles
5.2 Analytical specificity of measurement procedures
5.3 Commutability of calibrators
5.4 Commutability of control materials
Annex A (informative) List of IFCC primary reference measurement
procedures
Annex B (informative) List of certified reference materials (CRM)
Annex ZA (informative) Clauses of this European Standard addressing
essential requirements or other provisions of EU Directives
Bibliography
Covers how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 18153:2003 | Identical |
| UNI EN ISO 18153 : 2004 | Identical |
| BS EN ISO 18153:2003 | Identical |
| ISO 18153:2003 | Identical |
| UNE-EN ISO 18153:2004 | Identical |
| DIN EN ISO 18153:2003-11 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.