DIN EN ISO 7197-2009 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components (ISO 7197 2006 including Cor 1 2007) English version of DIN EN ISO 7197 2009-08.pdf

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1、August 2009DEUTSCHE NORM English price group 9No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!$Y=j“1542671ww

2、w.din.deDDIN EN ISO 7197SupersedesDIN EN ISO 7197:2006-09 and1:2008-06See start of validitywww.beuth.deDocument comprises 14 pagesDIN EN ISO 7197 CorrigendumNeurosurgical implants Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor. 1:2007) English version of DIN EN

3、 ISO 7197:2009-08 Neurochirurgische Implantate Sterile Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile (ISO 7197:2006, einschlielich Cor. 1:2007) Englische Fassung DIN EN ISO 7197:2009-08 DIN EN ISO 7197:2009-08 2 Start of validity This standard takes effect on 1 August 2009. DIN EN I

4、SO 7197:2006-09 and DIN EN ISO 7197 Corrigendum 1:2008-06 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secre

5、tariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-16 AA Neuro-chirurgische Implantate. This standard contains specifications meeting the ess

6、ential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International and European Standards referred to in clause 2 of this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 14630 DIN EN ISO 14630 ASTM F 640:1979 obtainable from Beu

7、th Verlag GmbH, 10772 Berlin Amendments This standard differs from DIN EN ISO 7197:2006-09 and DIN EN ISO 7197 Corrigendum 1:2008-06 as follows: requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Co

8、uncil of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN

9、ISO 7197: 2006-09 DIN EN ISO 7197 Corrigendum 1: 2008-06 National Annex NA (informative) Bibliography DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 14630, Non-active surgical implants General requirements a) Ann

10、ex ZA (informative) concerning the relationship between this European Standard and the essential EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7197 May 2009 ICS 11.040.40 Supersedes EN ISO 7197:2006English Version Neurosurgical implants - Sterile, single-use hydrocephalus shunts and compo

11、nents (ISO 7197:2006, including Cor. 1:2007)Implants neurochirurgicaux - Systmes de drivation et composants striles, non rutilisables, pour hydrocphalie (ISO 7197:2006, Cor. 1:2007 inclus) Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile (ISO 7197

12、:2006, einschlielich Cor. 1:2007) This European Standard was approved by CEN on 19 April 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-da

13、te lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under t

14、he responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hung

15、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centr

16、e: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7197:2009: EContents Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 General requirements for sh

17、unts.6 4.1 General .6 4.2 Radiopacity 6 4.3 Biocompatibility.6 4.4 Resistance to leakage.6 4.5 Control of the implanted shunt 7 4.6 Pressure-flow characteristics of the valve, the components and the pre-assembled shunt7 4.7 Identification of shunts in vivo 7 4.8 Ability to withstand overpressure .7

18、4.9 Dynamic breaking strength 7 4.10 Behaviour under MR imaging conditions .7 4.11 Bursting pressure7 5 Specific requirements for components.8 5.1 Valves .8 5.1.1 Reflux performance of shunts connecting the ventricle to the blood system8 5.1.2 Long term stability 8 5.1.3 Influence of the changed pos

19、ture of the patient on the valve performance .8 5.2 Resistance of tubing and components .8 6 Marking and labelling of shunts 8 7 Packaging.8 8 Information supplied by the manufacturer .9 8.1 General .9 8.2 Instructions for use.9 8.3 Patient identification card 9 Bibliography10 Annex ZA (informative)

20、 Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .11 2 DIN EN ISO 7197:2009-08 EN ISO 7197:2009 (E) Page Foreword 3 EN ISO 7197:2009 (E) DIN EN ISO 7197:2009-08 The text of ISO 7197:2006, including Cor. 1:2007 has been prepared by Technical Commit

21、tee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 7197:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European Standard shall be given the status of

22、a national standard, either by publication of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of

23、 patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 7197:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports ess

24、ential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand

25、ard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

26、Endorsement notice The text of ISO 7197:2006, including Cor. 1:2007 has been approved by CEN as a EN ISO 7197:2009 without any modification. Introduction A shunt is defined as an artificial connection of two compartments inside the body. For the treatment of hydrocephalus, the ventriculo-atrial shun

27、t has been introduced initially to control the intraventricular pressure in the brain of the patients. Today ventriculo-peritoneal shunts are preferably implanted. In special cases, a lumbo-peritoneal shunt is implanted. Normally a hydrocephalus shunt includes a valve which determines the resulting

28、intraventricular pressure in the brain of the patients and influences the flow rate through the shunt. The following types of valve are currently commercially available. a) Conventional differential-pressure valves (DP-valves) are designed as ball-in-cone valves, membrane valves or silicone slit val

29、ves. They have one characteristic opening pressure. If the difference pressure between inlet and outlet exceeds this opening pressure the device opens. After opening, the different types of DP-valve show a wide range of different flow characteristics. Differences due to a changed posture of the pati

30、ent have no intended impact on the function of the devices. b) Adjustable DP-valves act like conventional DP-valves. In contrast to non-adjustable devices they introduce the possibility of a non-invasive readjustment of the opening characteristic after implantation. They do not take into account cha

31、nges due to a changed posture of the patient. c) Gravitation valves or hydrostatic devices take into account the changed physics in a shunt due to a changed posture of the patient. These devices aim to avoid an unphysiological negative intraventricular pressure in the upright position of the patient

32、, which might be the consequence of the hydrostatic pressure in shunts with adjustable or not adjustable DP-valves. There are three different hydrostatic devices commercially available: flow-reducing devices, valves with a so-called “anti-siphon-device” or “siphon-control-device” and gravity-assiste

33、d devices. d) Other adjustable valves, e.g.: gravitation valves: adjustable hydrostatic devices present in addition to the characteristics of hydrostatic devices (group 4) with the possibility of a non-invasive readjustment of the opening performance of the device; adjustable anti-siphon-device valv

34、es; adjustable flow-reducing valves. Although the technical and phenomenological performance of the devices is significantly different, no design has scientifically been proven to be superior. Due to the important technical differences, specific testing procedures are necessary to investigate the pe

35、rformance of the different valves. 4 DIN EN ISO 7197:2009-08 EN ISO 7197:2009 (E) 1 Scope This International Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes

36、and reservoirs. This International Standard gives no recommendation concerning the superiority of a certain type of valve. For manufacturing, it defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufactu

37、rer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer. The benefit of this International Standard for the surgeon and the patient is to understand the information given by the manufacturer and to obtain sta

38、ndardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture. This Internat

39、ional Standard does not apply to active implants for the treatment of hydrocephalus. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of t

40、he referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 14630:2005, Non-active surgical implants General requirement ASTM F2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in

41、the Magnetic Resonance Environment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accompanying documents document accompanying a medical device, or an accessory, and containing important information for the user, operator, installer or assem

42、bler of the medical device, particularly regarding safety supplied by the manufacturer NOTE Adapted from ISO 14971:2000. 5 EN ISO 7197:2009 (E) DIN EN ISO 7197:2009-08 3.2 hydrocephalus state of excessive accumulation of cerebro-spinal fluid CSF with the ventricular system of the head due to a distu

43、rbance of secretion, flow or absorption 3.3 hydrocephalus shunt single-use device(s) typically consisting of an inflow catheter, a pressure-controlling device, and an outflow catheter intended to regulate the pressure of cerebro-spinal fluid CSF 3.4 instructions for use parts of accompanying documen

44、ts provided by the manufacturer, giving the necessary information for safe and proper use 3.5 lumbo-peritoneal drainage drainage of cerebro-spinal fluid CSF from the lumbar sub-arachnoid spaces into the peritoneum 3.6 patient identification card card identifying its holder and issuer, which carries

45、data on the hydrocephalus shunt implanted 3.7 ventriculo-atrial drainage drainage of cerebro-spinal fluid CSF from the ventricles into the right atrium of the heart 3.8 ventriculo-peritoneal drainage drainage of cerebro-spinal fluid CSF from the ventricles into the peritoneum 4 General requirements

46、for shunts 4.1 General The sample size shall be justified and stated. 4.2 Radiopacity All external parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque markers. All parts of the shunt shall be identifiable via X-ray examination. NOTE Guidance can be found in ASTM F640

47、. 4.3 Biocompatibility The biocompatibility of hydrocephalus shunts and components shall be assessed. Guidance is given in the principles and methods recommended in ISO 10993-1. 4.4 Resistance to leakage Resistance to leakage shall be measured using air. All parts of the shunt shall show no signs of

48、 leakage with a differential pressure from inside to outside of 9,806 7 kPa (1 m water column) within 5 min. 6 DIN EN ISO 7197:2009-08 EN ISO 7197:2009 (E) 4.5 Control of the implanted shunt The functionality of the shunt and the method of control of the implanted shunt shall be stated in the accomp

49、anying documents. If no test is possible, the manufacturer shall state this fact in the instructions for use and the accompanying documents. 4.6 Pressure-flow characteristics of the valve, the components and the pre-assembled shunt The pressure-flow characteristics of the valve shall be tested and monitored in the relevant flow range of (5 to 50) ml/h. A graph showing the pressure/flow characteristics shall be included in the accompanying documents. The manufacturer shall state if the complete system (catheter, reservoir and other devices) causes fundament