GOST ISO 14160-2011 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid sterilants《包含动物源材.pdf

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5、:2000 Quality management systems. Requirements ( . -)ISO 9002:1994 Quality systems Model for quality assurance in production, installation and servicing( . , )ISO 9004-1:1994 Quality management and quality system elements Part 1: Guidelines( . 1. -)1 ISO 141602011 ISO 11134:1994 Sterilization of hea

6、lth care products. Requirements for validation and routine control.Industrial moist heat sterilization ( . - . )ISO 11135:1994Medicaldevices.Validationandroutinecontrolofethyleneoxidesterilization(- . )ISO 11137:1995 Sterilization of health care products. Requirements for validation and routine cont

7、rol.Radiation sterilization ( . -. )ISO 11138-1:1994 Sterilization of health care products. Biological indicators. Part 1. General (C- . . 1. )ISO 11737-1:1995 Sterilization of medical devices. Microbiological methods. Part 1. Estimation ofpopulation of microorganisms on products ( . . 1. )ISO 13408

8、-1:1998 Aseptic processing of health care products Part 1: General requirements( . 1. )ISO 13485:1996 Quality systems Medical devices Particular requirements for the application ofISO 9001 ( . . ISO 9001)ISO 13488:1996 Quality systems Medical devices Particular requirements for the application ofISO

9、 9002 ( . . ISO 9002)3 :3.1 , (batch): , , - .3.2 (bioburden): / / .3.3 (rri): , -.3.4 (commissioning): , - .3.5 (decimal reduction value); D(D value): , - 10 .3.6 (exposure time): , - .3.7 (inactivation): - , - / . - - , , .3.8 (inoculated carrier): , - -.3.9 (liquid chemical sterilant): , .3.10 (medical device): , , , ,- :- , , , ;- ,;- , ;- ,2 ISO 141602011 -, , .3.11 (performance qualification): , .3.12 (presterilizationcount):-, .3.13 (product compatibility): .3.14 (process development): -, , / , .3.15