[Validation of sterilization processes].
Sterilization is a special process, where the results of processes (efficacy of sterilization) cannot be verified by subsquent inspection and testing of the product (the items sterilized). For this reason sterilization process must be validated. Validation of sterilization processes is required by Medical Devices Directive 93/42 EEC and GMP. Also the sterilization processes in the hospitals shall be validated. The validation of sterilization of processes as described in European Standards: EN 550--for ethylene oxide EN 554--for moist heat.
Röhm-Rodowald
E
E
Zakład Zwalczania Skazeń Biologicznych Państwowego Zakładu Higieny w Warszawie.
Jakimiak
B
B
D004282:Documentation; D005069:Evaluation Studies as Topic; D006801:Humans; D011044:Poland; D013242:Sterilization / Q000379:methods / Q000592:standards*
Walidacja procesów sterylizacji.