GOST ISO 11737-2-2011 Sterilization of medical devices Microbiological methods Part 2 Tests of sterility performed in the validation of a sterilization process《医疗器械灭菌 微生物法 第2部分 用于验.pdf

1、C 2 , (ISO 11737-2:1998, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 11737-22011, 1.092 . 1.22009 . , - . , , -, . 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUUZTJ 4 13 2011 . 1277- ISO 11737-22011 1 2013 .5 ISO 11737-2:1998 Sterilizati

2、on ofmedical devices Microbiological methods Part 2: Tests of sterility performed in the validation of asterilization process ( . . 2. - , ). - .C (IDT). 11737-220036 ( ) - . - , - . - , 2013 -, II ISO 11737-220111 12 13 24 .25 .36 37 .4 () , 5 () - 11 13III ISO 11737-22011 , . - - . - , , - . . . /

3、 , - , , . . , . - , , . , - , . , , , - ISO 9001 ISO 9002 ISO 13485 1 ISO 13488 2 . ISO 9000 , , , - . , - . , - . - ISO 11134, ISO 11135 ISO 11137. , , , , . - . - (ISO 11137, ).IV ISO 11737-22011C 2 , Sterilization of medical devices. Microbiological methods.Part 2. Tests of sterility performed i

4、n the validation of a sterilization process 201301011 1.1 , , . .1.2 :) , ;b) ; ) b) ISO 11134, ISO 11135 ISO 11137.c) , . ISO 11138.2 .ISO 9001:1994 Quality systems Model for quality assurance in design, development, production,installation and servicing ( . , -, , )ISO 9001:2000 Quality management

5、 systems. Requirements ( . -)ISO 9002:1996 Quality systems Model for quality assurance in production, installation and servicing( . , )ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test ( -. )ISO 9004:1987 Quality management and quality system elements; Guidelines

6、 ( . )ISO 11134:1994 Sterilization of health care products. Requirements for validation and routine control.Industrial moist heat sterization ( . - . )ISO 11135:1994 Medical devices Validation and routine control of ethylene oxide sterilization (- . )ISO 11137:1995 Sterilization of health care produ

7、cts. Requirements for validation and routine control.Radiation sterilization ( . -. )1 ISO 11737-22011 ISO 11138-2:1994 Sterilization of health care products. Biological indicators. Part 2. Biologicalindicators for ethylene oxide sterilization ( . -. 2. )ISO 11737-1:1995 Sterilization of medical dev

8、ices. Microbiological methods. Part 1. Estimation ofpopulation of microorganisms on products ( . -. 1. )ISO/IEC Guide 2590 General Requirements for the Competence of Calibration and TestingLaboratories ( ).3 :3.1 (aerobic organism): , -.3.2 (anaerobic organism): , - -.3.3 / (bacteriostasis/fungistas

9、istest): , , - () .3.4 (culture conditions): , - , -.3.5 (facultative organism): , -, .3.6 (false negative): , .3.7 (false positive): , .3.8 (growth promotion test): , .3.9 / (product): , - .3.10 (product unit): , - .3.11 () (sample item portion, SIP): - , .3.12 (test of sterility): , - ( ).4 4.1 4.1.1 - , . - ISO 9001 ISO 9002.4.1.2 , , - .4.1.3 , ISO 9001. , , - .2 ISO 11737-22011 , - , .4.2 4.2.1 - , ISO 9001 ISO 9002.4.2.2 -, , .4.3 4.3.1 .4.3.2 , , - . -.4.3.3 , , , ISO 9001 ISO 9002.4.3.4 - , , , .4.3.5 - .5 5.1 5.1.1 , .5.1.2 () , -. , , . - , .