Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Also Known As:
SKU153254512
Published by
Deutsches Institut für Normung
DIN
Publication Date2015-11
Pages CountPages81
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.
Details
| Descriptors | 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, Procedures, Tanks, Release, Processes |
| ICS Codes | 11.080.99 - Other standards related to sterilization and disinfection |
| Language(s) | English |
| File Size | 2.2 MB |
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