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Normas DIN – AENOR
DIN EN ISO 11737-1:2009-09

DIN EN ISO 11737-1:2009-09

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009

Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 1: Détermination d'une population de micro-organismes sur des produits (ISO 11737-1:2006); Version allemande EN ISO 11737-1:2006 + AC:2009

Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2006); Deutsche Fassung EN ISO 11737-1:2006 + AC:2009

Fecha Anulación:
2018-07 /Withdrawn
Equivalencias internacionales:

EN ISO 11737-1 (2006-04)

EN ISO 11737-1/AC (2009-04)

ISO 11737-1 (2006-04)

TS EN ISO 11737-1 (2015-04-15)

Resumen:
This part of ISO 11737 specifies requirements and provides guidance for the enumeration and characterization of the population of viable microorgnisms on or in a medical device, component, raw material or package. This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoan contaminants.
Keywords:
Analysis, Applications, Assessment, Bacteria, Bacterial count, Bacteriological quality, Biological hazards, CE marking, Characteristics, Colony count, Concentration, Conditions, Contamination, Corrections, Counting, Culture, Culture media, Definitions, Determination, EDP, Elections, Equipment, Estimation, Evaluations, Filtration, Germs, Guide books, Hygiene, Incubation, Inspection, Instruments, Laboratories, Laboratory testing, Limits (mathematics), Loading, Materials, Mathematical calculations, Media, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Membranes, Methods, Methods of manufacture, Microbiological, Microbiological analysis, Microbiology, Micro-organisms, Microorganisms, Operation, Packages, Patterns, Personnel, Population, Products, Quality assurance, Quality management, Raw materials, Reclamation, Release, Safety, Samples, Sampling methods, Selection, Solutions, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Substances, Testing, Transfer, Transport, Treatment, Validation, Verification
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