ГОСТ РЕН 12322—2010
Приложение В
(справочное)
Библиография
EN 46001 EN
46002 EN
ISO 9001
(ISO 9001.1994)
(ISO 9002.1994)
DIN 58959-6
DIN 58959-6.
Supplement 1
DIN 58959-7
Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001
Quality systems — Medical devices— Particular requirements for the application of EN ISO 9002
Quality systems — Model for quality assurance in design/development, production, installation and
servicing (ISO 9001:1994)
EN ISO 9002Quality systems — Model for quality assurance in production. mstaBation and servicing
DIN 58959-9.
Supplement 1
DIN S9959-9
(ISO 9002:1994)
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
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
Quality management In medical microbiology — Part 7: General requirements for the use of control
strains
Quality management In medical microbiology — Part 9: Requirements for the use of control strains
for testing culture media
Quality management in medical microbiology — Part 9: Requirements for the use of control strains
for testing culture media
|1 JPower. D. A. Quality Control of Commercially Prepared Bacteriological Media. In: Pner. 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)MacFaddln, J. F.. ed. Media for Isolation — Cultivation — Identification — Maintenance of Medical Bactena. Vol
1. Williams & Wilkins. Baltlmore-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 der medizmischen Mlkrobiologie. DGHM-Verfahrensrtchtlmlen fur
die mikrobiologische Diagnostic Tell4.1. Qualitatssicherung. Gustav Fischer Verlag, Stuttgart — New York. 1985
|7]Cosun. J. D.. M. Kappner. Qualitatssicherung von Trockenmateriaben fur die Mlkrobiologie. Abstr. 28.
DGHM-Tagung. Gottingen, FRG. 1981
(8)Kirsop. В. E.. Doy*e. 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] CosUn, I. D. Quality Assurance and Quality Control of Ingredients for Microbiological Culture Media. In: Quality
Assurance and Quality Controlof Microbiological Culture Media. J.E.L. Corry (ed ). G-l-T Verlag. DarmstadL 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 et al. (ed.). Elsevier. Amsterdam. 1995, pp. 1—23
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