Приложение В (справочное) Библиография

Приложение В
(справочное)

Библиография

EN 46001	Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
EN 46002	Quality systems - Medical devices- Particular requirements for the application of EN ISO 9002
EN ISO 9001 (ISO 9001:1994)	Quality systems - Model for quality assurance in design/development, production, installation and servicing (ISO 9001:1994)
EN ISO 9002 (ISO 9002:1994)	Quality systems - Model for quality assurance in production, installation and servicing (ISO 9002:1994)
DIN 58959-6	Quality management in medical microbiology - Part 6: Requirements for control strains - Examples for production and preservation of bacteria used as stock cultures and working cultures
DIN 58959-6, Supplement 1	Quality management in medical microbiology - Part 6: Requirements for control strains - Examples for production and preservation of bacteria used as stock cultures and working culture
DIN 58959-7	Quality management in medical microbiology - Part 7: General requirements for the use of control strains
DIN 58959-9, Supplement 1	Quality management in medical microbiology - Part 9: Requirements for the use of control strains Part 9: Requirements for the use of control strains for testing culture media
DIN 59959-9	Quality management in medical microbiology - Part 9: Requirements for the use of control strains Part 9: Requirements for the use of control strains for testing culture media

[1] Power, D.A. Quality Control of Commercially Prepared Bacteriological Media. In: Prier, J.E., Bartola, J.T., Friedmann, H (eds.). Quality Control in Microbiology, University Park Press, Baltimore, 1975, pp. 47 - 53

[2] Miller, J.M. Media and Reagents. In: Miller, J.M., Wentworth, В.B. (eds.). Methods for Quality Control in Diagnostic Microbiology, American Public Health Association, Washington D.C., 1985, pp. 59-87

[3] MacFaddin, J.F., ed. Media for Isolation - Cultivation - Identification - Maintenance of Medical Bacteria. Vol 1. Williams & Wilkins, Baltimore-London, 1985, pp. 928

[4] Campbell, M.C., J.L. Stewart (eds.). Media Quality Control Tests. In: The Medical Mycology Handbook, J. Wiley & Sons, New York, 1980, pp. 393 - 397

[5] Quality Assurance for Commercially Prepared Microbiological Culture Media - Second Edition; Approved Standard. NCCLS publication M22-A. Villanova, PA., USA, 1990, pp. 24

[6] Burkhardt, E. (Publisher): Qualitatssicherung in dermedizinischen Mikrobiologie. DGHM-Verfahrensrichtlinienfur die mikrobiologische Diagnostik. Teil 4.1. Qualitatssicherung. Gustav Fischer Verlag, Stuttgart - New York, 1985

[7] Costin, J.D., M. Kappner. Qualitatssicherung von Trockenmaterialien fur die Mikrobiologie. Abstr. 28. DGHM-Tagung, Gottingen, FRG, 1981

[8] Kirsop, В.E., Doyie, A. eds. Maintenance of Microorganisms and Cultured Cells - A Manual of Laboratory Methods, 2nd. ed. Academic Press, London - New York, 1991

[9] European Culture Collection's Organization (ECCO). ICECC Publication No. 4 - Information on holdings and services. Information Center for European Culture Collections (ICECC), Mascheroder Weg 1b, D-38124 Braunschweig, FRG, 1992

[10] European Pharmacopoeia. 2.6 - Biological tests. 2.6.1 Sterility - culture media - sterility, 1999

[11] Sewell, D., L. Quality Assurance, Quality Control, Laboratory Records, and Water Quality. In: Clinical Microbiology Procedures Handbook, Volume 2, Section 13. H. D. Isenberg, ed., American Society for Microbiology, Washington, D.C., 1992

[12] Isenberg, H.D. (ed.). Clinical Microbiology Procedures Handbook. Volume 2, Chapters 13.1 and 13.2.4 to 13.2.22, American Society for Microbiology, Washington, D. C, USA, 1992

[13] Costin, I.D. Quality Assurance and Quality Control of Ingredients for Microbiological Culture Media. In: Quality Assurance and Quality Control of Microbiological Culture Media, J.E.L. Corry (ed.). G-l-T Verlag, Darmstadt, FRG, 1982, pp. 65 - 87

[14] Woolsen, R.F. (ed.). Statistical Methods for the Analysis of Biomedical Data. John Wiley & Sons, Inc., New York, USA, 1987

[15] World Directory of Collections of Cultures of Microorganisms, 4th Edition, Eds. H. Sugawara, M. Juncai, M. Saturo, T. Youko. Published by the WFCC's World Data Center on Microorganisms, 1993

[16] Weenk G.H. Microbiological assessment of culture media: Comparison and statistical evaluation of methods. In: Culture media for food microbiology, J.E.L. Corry etal. (ed.). Elsevier, Amsterdam, 1995, pp. 1 - 23