1、BS EN ISO7197:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNeurosurgical implants Sterile, single-usehydrocephalus shuntsand components (ISO7197:2006, includingCor 1:2007)This British Standard was published under the authority of the Standard
2、s Policy and Strategy Committee on 31 October 2009 BSI 2009ISBN 978 0 580 68136 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7197:2009National forewordThis British Standard is the UK implementation of EN ISO 7197:2009. It is identical to ISO 7197:2006, incorporating corrigen
3、dum 1:2007. It supersedes BS EN ISO 7197:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/3, Neurosurgical implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not p
4、urport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7197May 2009ICS 11.040.40 Supersedes EN ISO 7197:2006
5、 English VersionNeurosurgical implants - Sterile, single-use hydrocephalusshunts and components (ISO 7197:2006, including Cor 1:2007)Implants neurochirurgicaux - Systmes de drivation etcomposants striles, non rutilisables, pour hydrocphalie(ISO 7197:2006, Cor 1:2007 inclus)Neurochirurgische Implanta
6、te - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile (ISO7197:2006, 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 Eur
7、opeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English
8、, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cypr
9、us, 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 United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT
10、EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 7197:2009: EBS EN ISO 7197:2009EN ISO 7197:2009 (E) 3 Foreword The te
11、xt of ISO 7197:2006, including Cor 1:2007 has been prepared by Technical Committee 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 secretaria
12、t of which is held by DIN. This European Standard shall be given the status of 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 t
13、he possibility that some of the elements of this document may be the subject of 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 th
14、e European Commission and the European Free Trade Association, and supports essential 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 orga
15、nizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, R
16、omania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 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. BS EN ISO 7197:2009EN ISO 7197:2009 (E) 4 Annex ZA (informative) Relationship bet
17、ween this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach
18、 Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within t
19、he limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requiremen
20、ts (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1, 2, 3, 4, 5 Part of ER 1 relating to the risk of use error is not covered by current Standard. 4.2 2 4.3 7.1, 7.2 Part of ER 7.1 relating to biophysical and modelling research is not covered by this European Standard. 4.4 7.5 4.5 3, 4, 1
21、3.6.d) 4.6 3, 4, 9.1 4.7 2, 13.6.d), 13.6.e) 4.8 4, 9.2, 12.7.1 4.9 12.7.1 4.10 9.1, 9.2 4.11 12.7.1 5.1.1 2, 4 5.1.2 4 5.1.3 4, 9.2 5.2 9.1, 12.7.1 6 13.1 ER 13.1 is covered via EN ISO 14630. 7 5, 7.2 BS EN ISO 7197:2009EN ISO 7197:2009 (E) 5 8.1 13 The part of ER 13.3.a) relating to the informatio
22、n on the authorized representative is not addressed by this European Standard. 8.2 13.6 The ER 13.3 f is only partly addressed in this European Standard: safety issue of single use. The part of ER 13.6.h) relating to single use is not addressed in this European Standard. ER 13.6 q is not addressed i
23、n this European Standard. 8.3 13.6.e) 6.a ER 6.a) is not addressed by this European Standard. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 7197:2009ISO 7197:2006(E) ISO 2006 All rights reserved iiiForeword
24、 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical
25、 committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of elec
26、trotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the
27、 member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for iden
28、tifying any or all such patent rights. ISO 7197 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 3, Neurosurgical implants. This third edition cancels and replaces the second edition (ISO 7197:1997) which has been technically revised. BS EN ISO 7197:2009ISO 7197:
29、2006(E) iv ISO 2006 All rights reservedIntroduction A shunt is defined as an artificial connection of two compartments inside the body. For the treatment of hydrocephalus, the ventriculo-atrial shunt has been introduced initially to control the intraventricular pressure in the brain of the patients.
30、 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 intraventricular pressure in the brain of the patients and influences the flow rate through the shunt.
31、 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 valves. They have one characteristic opening pressure. If the difference pressure between inlet and outle
32、t 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 patient have no intended impact on the function of the devices. b) Adjustable DP-valves act like conventio
33、nal 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 changes due to a changed posture of the patient. c) Gravitation valves or hydrostatic devices take into a
34、ccount 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, which might be the consequence of the hydrostatic pressure in shunts with adjustable or not adjustab
35、le 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-assisted devices. d) Other adjustable valves, e.g.: gravitation valves: adjustable hydrostatic devices presen
36、t 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 valves; adjustable flow-reducing valves. Although the technical and phenomenological performance of the de
37、vices 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 performance of the different valves. BS EN ISO 7197:2009INTERNATIONAL STANDARD ISO 7197:2006(E) ISO 2006
38、 All rights reserved 1Neurosurgical implants Sterile, single-use hydrocephalus shunts and components 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,
39、like valves, tubes 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 giv
40、en by the manufacturer. 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 manufacture
41、r and to obtain standardized 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 manufac
42、ture. This International 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
43、latest edition of the 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 I
44、tems for Safety in 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,
45、 installer or assembler of the medical device, particularly regarding safety supplied by the manufacturer NOTE Adapted from ISO 14971:2000. BS EN ISO 7197:2009ISO 7197:2006(E) 2 ISO 2006 All rights reserved3.2 hydrocephalus state of excessive accumulation of cerebro-spinal fluid CSF with the ventric
46、ular system of the head due to a disturbance 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
47、 for use parts of accompanying documents 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
48、 its holder and issuer, which carries 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
49、the peritoneum 4 General requirements 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. 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 Resista
