KS P ISO TR 16142-2007 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices《医疗器械 医疗器械安全.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO/TR 16142 KS P ISO/TR 16142： 2007(2012 ) 2007 10 31 http:/www.kats.go.krKS P ISO/TR 16142： 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 10 31 ：2007 10 31 ：2012 12 6 ： 20120679 ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO/T

2、R 16142： 2007 i .1 1 1 2 .1 3 .2 4 2 4.1 2 4.2 2 5 2 6 .3 A( ) 4 B( ) 16 17 .18 KS P ISO/TR 16142： 2007 (2012 ) Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 1999 1 ISO/TR 16142, Medical devices Guida

3、nce on the selection of standards in support of recognized essential principles of safety and performance of medical devices , . 1 . , . 2 . 2.1 (basic standard) , , . 2.2 (group standard) , , . 2.3 (products standard) KS P ISO/TR 16142： 2007 2 , . 3 ( .) . (GHTF； B ) . . , . . . 4 4.1 . . , . . ( )

4、 . , , , . , . . 4.2 , . / . / . 5 , KS P ISO/TR 16142： 2007 3 . . A A.1 . A , , ( IEC 60601 , ISO 11140 .). , . A , , . 6 . ISO http:/www.iso.org IEC http:/www.iec.ch ISO IEC A . KS P ISO/TR 16142： 2007 4 A ( ) A.1 , . . . KS A ISO/IEC Guide 51, KS A ISO/IEC Guide 63, KS A ISO Guide 64, KS C IEC 60

5、513, . . A.1 I A.1 , , , , , . . ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969KS P ISO 14155( ) Medical devices Risk management Part 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 A.2

6、. ISO 14971 1 KS P ISO 13485Medical devices Risk management Part 1： Application of risk analysis ISO 9001 KS P ISO/TR 16142： 2007 5 A.1 ( ) , . ISO 13488 Quality systems Medical devices Particularrequirements for the application of ISO 9002 . ( ). , . . KS P ISO 14969 KS P ISO 13485 KS P ISO 13488 A

7、.3 , . ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969Medical devices Risk management Part 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 A.4 , A.1, A.2 A.3 , , . ISO 14971 1 KS P ISO 13

8、485ISO 13488 KS P ISO 14969KS P ISO 14155( ) Medical devices Risk management Part 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 A.5 , , . ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969

9、Medical devices Risk management Part 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 KS P ISO/TR 16142： 2007 6 A.1 ( ) A.6 . ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969Medical devices

10、 Risk managementPart 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 II A.7 , ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969KS P ISO 10993( ) Medical devices Risk managementPart 1： Appli

11、cation of risk analysis ISO 9001 Quality systems Medical devicesParticular requirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 A.7.1 I. “ ” . . , , , , . KS P ISO 14969KS P ISO 10993 ( ) KS P ISO 13485 KS P ISO 13488 A.7.2 , , . , . KS P ISO 14969KS P ISO 10993 ( ) KS P ISO 11

12、607( ) KS P ISO 13485 KS P ISO 13488 KS P ISO/TR 16142： 2007 7 A.1 ( ) A.7.3 , . , . KS P ISO 14969KS P ISO 10993 ( ) KS P ISO 11607( ) KS P ISO 13485 KS P ISO 13488 A.7.4 , / , . KS P ISO 10993( ) KS P ISO 11607( ) A.7.5 . ISO 14971 1 KS P ISO 10993( ) KS P ISO 11607( ) Medical devices Risk managem

13、ent Part 1： Application of risk analysis A.7.6 , . ISO 14971 1 Medical devices Risk management Part 1： Application of risk analysis A.8 ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969KS P ISO 11135 KS P ISO 11137KS P ISO 11134KS P ISO 11138( ) Medical devices Risk management Part 1： Application o

14、f risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 KS P ISO/TR 16142： 2007 8 A.1 ( ) A.8 ISO 11140 (series) KS P ISO 11607( ) KS P ISO 11737( ) ISO 13408 (series) ISO/TR 13409 ISO 13683 ISO 14160 ISO 14161 ISO

15、/TR 15843 ISO/TR 15844 Sterilization of health care productsChemical indicators Aseptic processing of health care productsSterilization of health care productsRadiation Sterilization Substantiation of 25kGy as a sterilization dose for small or infrequent production batches Sterilization of health ca

16、re productsRequirements for validation and routine control of moist heat sterilization in health care facilities Sterilization of single use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants Sterilization of health

17、care productsBiological indicators Guidance for the selection, use and interpretation of resultsSterilization of health care productsRadiation sterilization Product families, sampling plans verification dose experience and sterilization dose audits Sterilization of health care products Radiation ste

18、rilization Selection of sterilization dose for a single production batch A.8.1 , , . , . A.8 ISO 14971 1 Medical devices Risk managementPart 1： Application of risk analysis A.8.1.1 , . / / . A.8 ISO 14160 Sterilization of single-use medical devices incorporating materials of animal originValidation

19、and routine control of sterilizationby liquid chemical sterilants KS P ISO/TR 16142： 2007 9 A.1 ( ) , , , . . A.8.1.2 , . , , , , , . . A.8 A.8.2 , . ISO 14971 1 A.8 Medical devices Risk managementPart 1： Application of risk analysis A.8.3 . A.8 A.8.4 ( ) . A.8 KS M ISO 14644( ) A.8.5 , , . . ISO 14

20、971 1 A.8 Medical devices Risk managementPart 1： Application of risk analysis A.8.6 / . A.13.1 KS P ISO/TR 16142： 2007 10 A.1 ( ) A.9 ISO 14971 1 KS P ISO 13485ISO 13488 KS P ISO 14969KS P 1005 KS P 1006 Medical devices Risk management Part 1： Application of risk analysis ISO 9001 Quality systems Medical devices Particularrequirements for the application of ISO 9002 KS P ISO 13485 KS P ISO 13488 A.9.1 , , . . KS P 1005 KS P 1006 ISO 594(series) Conical f