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Part 7: Ethylene oxide sterilization residuals Part 8: Selection of reference materials (withdrawn) Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for skin sensitization Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials (available in English only)
ISO 11737 Sterilization of medical devices – Microbiological methods ISO 11737-1:2006 Part 1: Determination of a population of microorganisms on products; ISO 11737-2:2009 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; ISO/IEC 11756:1999 Information technology - Programming ...
Ethylene oxide treatment is the most common chemical sterilization method, used for approximately 70% of total sterilizations, and for over 50% of all disposable medical devices. [ 26 ] [ 27 ] Ethylene oxide treatment is generally carried out between 30 and 60 °C (86 and 140 °F) with relative humidity above 30% and a gas concentration between ...
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
In microbiology, in the context of a sterilization procedure, the D-value or decimal reduction time (or decimal reduction dose) is the time (or dose of an antimicrobial drug) required, at a given condition (e.g. temperature) or set of conditions, to achieve a one-log reduction, that is, to kill 90% of relevant microorganisms. [1]
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.