Implementation of traceability and uncertainty in in-vitro diagnostic products - Results of the Roche workshop "In Vitro Diagnostics Directive": Practical applications of uncertainty calculations

Accreditation and Quality Assurance

Volumn 9, Issue 1-2, 2004, Pages 47-51

  Andersson, J ^a   Kjer, H ^b   Odlund B M ^b   Linko, S ^c   Volkert E ^d  

^a UDDEVALLA HOSPITAL   (Sweden)

^b Roche Diagnostics Scandinavia AB   (Sweden)

^c HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^d ROCHE DIAGNOSTICS GMBH   (Germany)

Author keywords

Calibrator; In vitro diagnostics directive; IVD; Traceability; Uncertainty

Indexed keywords

ACCREDITATION; CALCULATION; CALIBRATION; CONFERENCE PAPER; DEVICE; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; IN VITRO STUDY; MEASUREMENT;

EID: 0842263561     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00769-003-0720-y     Document Type: Conference Paper

References (13)

1. European Union Directive 98/79/EC (1998) Journal of the European Communities, L 331/1, 7 December 1998
2. ISO FDIS 17511 (2002) Metrological traceability of values assigned to calibrators and control materials, International Organization for Standardization (ISO), Geneva, Switzerland
3. ISO FDIS 18153 (2002) Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials, ISO, Geneva, Switzerland
4. NCCLS EP5-A (1999) Evaluation of precision performance of clinical chemistry devices: approved guideline. National Committee for Clinical Laboratory Standards (NCCLS) document EP5-A. NCCLS, Wayne, Pa., USA
5. BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML (1995) Guide to the expression of uncertainty in measurement, 1st. edn. Geneva, Switzerland
6. ILAC-G17 (2002) Introducing the concept of uncertainty in measurement in testing in association with the application of the standard, ISO/IEC 17025. http://www.ilac.org
7. Eurachem/CITAC (2000) Guide quantifying uncertainty in analytical measurement, 2nd. edn. http://www.eurachem.ul.pt
8. EA-4/02 (1999) Expression of the uncertainty of measurement in calibration: http://www.european-accreditation.org/
9. GUM Workbench Version 1. Metrodata GmbH, Datenverarbeitung für Meßtechnik und Qualitätssicherung, 79639 Basler Straße 18, Grenzach-Wyhlen, Germany http://www.metrodata.de
10. EN ISO/IEC 17025 (1999) General requirements for the competence of testing and calibration laboratories. ISO, Geneva, Switzerland
11. EN ISO 15189 (2003) Medical laboratories - particular requirements for quality and competence. ISO, Geneva, Switzerland
12. Linko S (2003) Measurement tools for quality assurance in medical laboratories. Dissertation, University of Helsinki
13. Örnemark U, Uldall A, Van Nevel L, Aregbe Y, Taylor PDP (2002) IMEP-17: Trace and minor constituents in human serum - certification report, EUR 20243 EN: EC-JRC-IRMM, Geel, Belgium