1、 , (ISO 14160:1998, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) ISO141602011, 1.092 . 1.22009 . , - . , , -, 1 -()2 (-)3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJ 4 13 2011 . 1338- ISO 141602011 1 2013 .5 ISO 14160:1998 Sterilization ofsingle-u
2、se medical devices incorporating materials of animal origin. Validation and routine control of sterilizationby liquid sterilants ( , - . ). (IDT). - . 1416020036 -, - . () . , - - C, 2013 -, II ISO 1416020111 12 13 24 .35 46 .67 7 () 8 () c .15 17III ISO 141602011 , . , () . , (ISO 13485 ISO 13488)
3、, . .- . / , , - . , , . , - , . . , . , , , - ISO 9000, ISO 13485 ISO 13488. ISO 9000 , , , . , . , . , - , , . , () - / , , , -, . , ( ), . , - , (, ), ( ) - . - , , , .IV ISO 141602011 , Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine c
4、ontrol ofsterilization by liquid sterilants 201301011 , , , .,- .1 (ISO 9001 ISO 13485, ISO 9002 ISO 13488) , .2 , -, , . ,- , , ; 1.3 , , , (BSE) ( ). - . .2 :ISO 9001:1994 Quality systems Model for quality assurance in design, development, production,installation and servicing ( . , -, , )ISO 9001
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
