ГОСТ Р ЕН 12322-2010 Изделия медицинские для диагностики in vitro. Питательные среды для микробиологии. Критерии функциональных характеристик питательных сред

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 for testing culture media

DIN 59959-9

Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media

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

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

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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

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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

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