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Normas DIN – AENOR
DIN EN ISO 11137-2:2015-11

DIN EN ISO 11137-2:2015-11

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2013); Version allemande EN ISO 11137-2:2015

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2013); Deutsche Fassung EN ISO 11137-2:2015

Fecha:
2015-11 /Active
Equivalencias internacionales:

EN ISO 11137-2 (2015-06)

ISO 11137-2 (2013-06)

Relación con otras normas DIN:
Resumen:
This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. This part of IS 11137 also specifies methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.
Keywords:
Acceptance (approval), Biological hazards, Calibration, CE marking, Checks, Clearing, Containers, Definitions, Dose, Dosimeters, Dosimetry, Efficiency, Elections, Electron beams, Evaluations, Gamma-radiation, Germicides, Guide books, Health protection, Hygiene, Inspection, Ionizing radiation, Irradiation apparatus, Jets, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Performance, Personnel, Phototherapy, Plant, Product information, Public health, Public health protection, Qualifications, Quality management, Radiation, Radiation dose, Ray treatment, Routine tests, Specification (approval), Sterilization by irradiation, Sterilization (hygiene), Surveillance (approval), Validation, Verification, X-rays
150,37
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