KS P ISO 7197-2009 Neurosurgical implants－Sterile single-use hydrocephalus shunts and components《神经外科植入物 无菌的、一次性使用的脑积水分流管和组件》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 7197 KS P ISO 7197:2009 2009 12 25 http:/www.kats.go.krKS P ISO 7197:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 7197:2009 .1 1 1 2 1 3 .2 4

2、(General requirements for shunts) .2 4.1 (General) 2 4.2 (Radiopacity) 2 4.3 (Biocompatibility) 3 4.4 (Resistance to leakage) .3 4.5 (Control of the implanted shunt).3 4.6 , , - (Pressure-flow characteristics of the valve, the components and the pre-assembled shunt) 34.7 (Identification of shunts in

3、 vivo) 3 4.8 (Ability to withstand overpressure).3 4.9 (Dynamic breaking strength) .4 4.10 (Behaviour under MR imaging conditions)4 4.11 (Bursting pressure).4 5 (Specific requirements for components)4 5.1 (Valves) .4 5.2 (Resistance of tubing and components).5 6 (Marking and labelling of shunts) .5

4、7 (Packaging) 5 8 (Information supplied by the manufacturer) 5 8.1 (General) 5 8.2 (Instructions for use) .5 8.3 (Patient identification card) .5 7 i KS P ISO 7197:2009 Neurosurgical implantsSterile, single-use hydrocephalus shunts and components 2006 3 ISO 7197, Neurosurgical implants Sterile, sing

5、le use hydro- cephalus shunts and components . 1 , . , , . . . , . . . . 2 . . ( ) . KS P ISO 10993 1, 1 ： KS P ISO 14630, ASTM F2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment KS P ISO 7197:2009 3 . 3.1 (accompanying documents)

6、 , , , , , ISO 14971： 2000 . 3.2 (hydrocephalus) , , 3.3 (hydrocephalus shunt) , , 3.4 (instruction for use) 3.5 - (lumbo-peritoneal drainage) 3.6 (patient identification card) 3.7 - (ventriculo-atrial drainage) 3.8 - (ventriculo-peritoneal drainage) 4 (General requirements for shunts) 4.1 (General)

7、 . 4.2 (Radiopacity) . 2 KS P ISO 7197:2009 X . ASTM F640 . 4.3 (Biocompatibility) KS P ISO 10993 1 . 4.4 (Resistance to leakage) . 5 9.806 7kPa( 1 m) . 4.5 (Control of the implanted shunt) . , . 4.6 , , - (Pressure-flow characteristics of the valve, the components and the pre-assembled shunt) - 5 m

8、L/h50 mL/h . - . ( , ) - . - . 1 mm ( 5.2 ). (5.1.3 ). 8.2 g) . 4.7 (Identification of shunts in vivo) . . X . 4.8 (Ability to withstand overpressure) 9.806 7 kPa(1 m ) 3 KS P ISO 7197:2009 . 4.9 (Dynamic breaking strength) (1 0.2) Hz . 10 % 5 N . 100 000 . , . 4.10 (Behaviour under MR imaging condi

9、tions) ASTM F2503-05 MR( ) . 4.11 (Bursting pressure) 10 % 19.613 3 kPa ( 2 m) . 2 . 5 (Specific requirements for components) 5.1 (Valves) 5.1.1 (Reflux performance of shunts connecting theventricle to the blood system) 0.04 mL/min 0 kPa4.903 3 kPa(0 mm500 mm ) . 5.1.2 (Long term stability) . 5 28 2

10、0 mL/h , ( ： ) . 5.1.3 (Influence of the changed posture of the patient on the valve performance) . (4.6 ). 4 KS P ISO 7197:2009 5.2 (Resistance of tubing and components) - . . 6 (Marking and labelling of shunts) KS P ISO 14630 11.2, 11.5 . . 20 mL/h . 7 (Packaging) KS P ISO 14630 10. . 8 (Informati

11、on supplied by the manufacturer) 8.1 (General) KS P ISO 14630 11. . 8.2 (Instructions for use) . a) b) . c) d) e) 5 mL/h 50 mL/h . . f) . g) . 10 mL/h 20 mL/h 0 kPa 0.490 3 kPa(0 mm 500 mm ) ( ). h) (MR) i) j) 8.3 (Patient identification card) . 5 KS P ISO 7197:2009 . a) ( , , , ) b) X c) X d) e) f)

12、 6 KS P ISO 7197:2009 1 ISO 11134, Sterilization of health care productsRequirements for validation and routine control Industrial moist heat sterilization 2 KS P ISO 11135, 3 ISO 11137： 19951), Sterilization of health care productsRequirements for validation and routine control Radiation sterilizat

13、ion 4 ISO 11137： 1995/Cor. 1：1997, Sterilization of health care productsRequirements for validation and routine control Radiation sterilizationTechnical Corrigendum 1 5 ISO 11137： 1995/Amd. 1：2001, Sterilization of health care products Requirements for validation and routine control Radiation steril

14、izationAmendment 1 ：Selection of items for dose setting 6 KS P ISO 14155 1, 1 ： 7 KS P ISO 14155 2, 2 ： 8 ISO 14971： 2000, Medical devices Application of risk management to medical devices 9 ASTM F640-79, Standard Test Methods for Radiopacity of Plastics for Medical Use 10 ASTM F647-94, Standard Pra

15、ctice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application 11 ASTM F2038-00e1, Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I Formulations and Uncured Materials 12 ASTM F2042-00e1, Standard Guide for Silicone Elastomers,

16、 Gels, and Foams Used in Medical Applications Part II Crosslinking and Fabrication 1) ： KS P ISO 111371, 1 ： , KS P ISO 111372, 2 ： KS P ISO 111373, 3 ： 7 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 7197:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Neurosurgical implantsSterile, single-use hydrocephalus shuntsand components ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr