Assessment of package inserts for diagnostic kits

Clinical Chemistry and Laboratory Medicine

Volumn 37, Issue 6, 1999, Pages 663-665

  Secchiero, Sandra ^a,c   Sciacovelli, Laura ^a   Bonvicini, Piero ^b   Zaninotto, Martina ^b   Plebani, Mario ^a,b  

^a Center of Biomedical Research   (Italy)

^b UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^c PET Center   (Italy)

Author keywords

Diagnostic kit; External quality assurance; Package insert

Indexed keywords

REAGENT;

ANALYTICAL EQUIPMENT; ARTICLE; INFORMATION; LABORATORY TEST; MARKETING; PRIORITY JOURNAL; QUALITY CONTROL;

PRODUCT LABELING; QUALITY CONTROL; REAGENT KITS, DIAGNOSTIC;

EID: 0032841892     PISSN: 14346621     EISSN: None     Source Type: Journal    
DOI: 10.1515/CCLM.1999.103     Document Type: Article

References (8)

1. NCCLS. Approved Standard ASL-1. Labelling of clinical laboratory materials. First edition. Villanova, PA: National Committee for Clinical Laboratory Standards, 1975.
2. ECCLS. Standard for the labelling of clinical laboratory materials. Berlin - Köln: Beuth Verlag, 1985; Vol. 2, N.3.
3. WHO. Guiding principles and recommendations on labelling of clinical laboratory materials. WHO memorandum. Bulletin of the World Health Organization 1978; 56:881-5.
4. Rubin M, Barnett RN, Bayse D, Beutler E, Brawn SB, Logan JE, et al. Provisional recommendation (IFCC 1978) on evaluation of diagnostic kits. Part 1. Recommendations for specifications on labelling of clinical laboratory materials. Clin Chim Acta 1979; 95:155F-62F.
5. EN 375. In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use, 1992.
6. + Oxidoreductase, EC 1.1.1.27). Eur J Clin Chem Clin Biochem 1994; 32:639-55.
7. EN ISO 9001. Quality systems. Model for quality assurance in design, development, production, installation and servicing, 1994.
8. EN ISO 9004/2. Quality management and quality system elements. Guidelines for services, 1991.