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1、BRITISH STANDARD BS EN 540:1993 Incorporating Amendment No. 1 Clinical investigation of medical devices for human subjects The European Standard EN 540:1993 has the status of a British Standard UDC 615.471:615.478:620.1:62-78 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00
2、2006, Uncontrolled Copy, (c) BSI BS EN 540:1993 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 August 1993 BSI 12-1998 The following BSI references rel
3、ate to the work on this standard: Committee reference HCC/26 Draft for comment 91/55752 DC ISBN 0 580 22079 6 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of the
4、 following countries: AustriaOesterreichisches Normungsinstitut BelgiumInstitut belge de normalisation DenmarkDansk Standardiseringsraad FinlandSuomen Standardisoimisliito, r.y. FranceAssociation franaise de normalisation GermanyDeutsches Institut fr Normung e.V. GreeceHellenic Organization for Stan
5、dardization IcelandTechnological Institute of Iceland IrelandNational Standards Authority of Ireland ItalyEnte Nazionale Italiano di Unificazione LuxembourgInspection du Travail et des Mines NetherlandsNederlands Normalisatie-instituut NorwayNorges Standardiseringsforbund PortugalInstituto Portugus
6、da Qualidade SpainAsociacin Espaola de Normalizacin y Certificacin SwedenStandardiseringskommissionen i Sverige SwitzerlandAssociation suisse de normalisation United KingdomBritish Standards Institution Amendments issued since publication Amd. No.DateComments 8162March 1994Indicated by a sideline in
7、 the margin Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 540:1993 BSI 12-1998i Contents Page Cooperating organizationsInside front cover National forewordii Foreword2 Text of EN 5403 National annex NA (informative) Committees respon
8、sibleInside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 540:1993 ii BSI 12-1998 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is the Engli
9、sh language version of EN 540:1993 Clinical investigation of medical devices for human subjects, published by the European Committee for Standardization (CEN). EN 540 was produced as a result of international discussions in which the United Kingdom took an active part. A British Standard does not pu
10、rport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front
11、 cover, pages i and ii, the EN title page, pages 2 to 12, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffield
12、un, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 540 June 1993 UDC 615.471:615.478:620.1:62-78 Descriptors: Medical equipment, safety, accident prevention, hazards, estimation, humans, clinical testing, specifications, commer
13、ce English version Clinical investigation of medical devices for human subjects Investigation clinique des dispositifs mdicaux sur les sujets humains Klinische Prfung von medizinischen Gerten fr Versuchspersonen This European Standard was approved by CEN on 1993-06-21. CEN members are bound to compl
14、y 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-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secr
15、etariat 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 the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the offi
16、cial versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de
17、Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1993 Copyright reserved to CEN members Ref. No. EN 540:1993 E Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 540:1993 BSI 12-1998 2 For
18、eword This European Standard was prepared by CEN TC 258 “CLINICAL INVESTIGATION OF MEDICAL DEVICES”. This European Standard has been prepared under a Mandate given to CEN by the Commission of the European Communities (and the secretariat of the European Free Trade Association) and supports Annexes o
19、n Clinical Evaluation of relevant EC Directive(s). In this European Standard, the words defined in clause 3 are written in capital letters. International work is currently underway within ISO TC 194/WG 4, and this European Standard is in technical conformity with ISO CD 10993-8 which deals with the
20、same subject. 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 December 1993, and conflicting national standards shall be withdrawn at the latest by December 1993. According to the CEN/CENELEC Inte
21、rnal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents Page Foreword2 0Introduction3
22、 1Scope3 2Normative references3 3Terminology and definitions3 4General requirements4 5Methodology5 6Presentation of the results10 Annex A (informative) Bibliography11 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 540:1993 BSI 12-19983 0
23、 Introduction This European Standard was prepared to define procedures to assist manufacturers, regulatory authorities, SPONSORS and CLINICAL INVESTIGATORS on the conduct and performance of the CLINICAL INVESTIGATION of MEDICAL DEVICES. This European Standard is intended to protect SUBJECTS and ensu
24、re the scientific conduct of the CLINICAL INVESTIGATION. 1 Scope 1.1 This European Standard pertains to the CLINICAL INVESTIGATION in human SUBJECTS of those MEDICAL DEVICES whose the clinical PERFORMANCE needs assessment before being placed on the market. This European Standard does not apply to in
25、 vitro diagnostic devices. 1.2 This European Standard specifies the requirements for the conduct of CLINICAL INVESTIGATIONS and documentation on whether the MEDICAL DEVICE achieves the performance intended by the SPONSOR; to determine any undesirable side effects, under normal conditions of use; to
26、permit the assessment of the acceptable risks having regard to the intended PERFORMANCE OF THE MEDICAL DEVICE. 1.3 This European Standard provides a framework for the preparation of written procedures for the organization, design, implementation, data collection and documentation of the CLINICAL INV
27、ESTIGATION. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments
28、to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. World Medical Association Declaration of Helsinki; recommendations guiding physicians
29、in biomedical research involving human subjects. 3 Terminology and definitions For the purposes of this European Standard, the following definitions apply. 3.1 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software
30、 necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap; investigation, replaceme
31、nt or modification of the anatomy or of a physiological process; control of conception. and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTEThis definition
32、is taken from the Medical Device Directive. 3.2 device; device intended for clinical investigation any MEDICAL DEVICE intended for use by an appropriately qualified practitioner when conducting CLINICAL INVESTIGATIONS in an adequate clinical environment 3.3 clinical investigation any systematic stud
33、y in human SUBJECTS, undertaken to verify the safety and PERFORMANCE of a specific MEDICAL DEVICE, under normal conditions of use 3.4 clinical investigation plan; protocol a document which includes detailed information on the rationale, aims and objectives, design and proposed analyses, methodology,
34、 and conduct of the CLINICAL INVESTIGATION 3.5 clinical investigator the investigator responsible for the conduct of a CLINICAL INVESTIGATION and who takes the clinical responsibility for the well-being of the SUBJECTS involved Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:0
35、0 2006, Uncontrolled Copy, (c) BSI EN 540:1993 4 BSI 12-1998 3.6 performance of the device the action of a specific MEDICAL DEVICE with reference to its intended use when correctly applied to appropriate SUBJECTS 3.7 ethics committee; research ethics committee; institutional review board; comit cons
36、ultatif de protection des personnes dans la recherche biomdicale an independent and properly constituted body of medical professionals and non-medical members, appointed in accordance with current practice, whose responsibility is to ensure that the safety, well-being and human rights of the SUBJECT
37、S participating in a particular CLINICAL INVESTIGATION are protected NOTEThe legal status, constitution and regulatory requirements pertaining to ETHICS COMMITTEES or similar institutions may differ among countries. 3.8 final report of clinical investigation a comprehensive description of the CLINIC
38、AL INVESTIGATION on completion 3.9 sponsor; promoter an individual or an organization which takes responsibility for the initiation and/or implementation of a CLINICAL INVESTIGATION NOTEWhen a CLINICAL INVESTIGATOR independently initiates and takes full responsibility for the CLINICAL INVESTIGATION,
39、 the CLINICAL INVESTIGATOR assumes the role of SPONSOR as well. 3.10 subject a human being, either a patient or a non-patient volunteer, participating in a CLINICAL INVESTIGATION 3.11 informed consent; consent the voluntary confirmation and documentation of a SUBJECTs willingness (or his legal guard
40、ian or representatives permission) to participate in a particular investigation, after information has been given to the SUBJECT on the nature of the CLINICAL INVESTIGATION 3.12 monitor a person appointed by the SPONSOR and responsible to him for monitoring and reporting on the progress of the CLINI
41、CAL INVESTIGATION 3.13 adverse event any undesirable clinical occurrence in a SUBJECT whether it is considered to be DEVICE related or not 3.14 adverse device effect; undesirable side effect a DEVICE related ADVERSE EVENT NOTEAn ADVERSE EVENT or an ADVERSE DEVICE EFFECT may be mild, moderate, or sev
42、ere and are usually unexpected. If, as a result of an ADVERSE EVENT during a CLINICAL INVESTIGATION, a SUBJECT has to be hospitalized, or their hospitalization is unduly prolonged because of potential disability or danger to life or because an intervention has been necessitated or the event is termi
43、nal, the ADVERSE EVENT or ADVERSE DEVICE EFFECT is regarded as severe. For example, if an ADVERSE EVENT or ADVERSE DEVICE EFFECT causes foetal distress, foetal death or a congenital anomaly or malignancy results from the use of the DEVICE during a CLINICAL INVESTIGATION, this also would be classifie
44、d as a severe ADVERSE EVENT or ADVERSE DEVICE EFFECT. 3.15 multicentre investigation a CLINICAL INVESTIGATION, conducted according to a single CLINICAL INVESTIGATION PLAN, which takes place at different investigational sites 3.16 principal clinical investigator a CLINICAL INVESTIGATOR appointed by t
45、he SPONSOR to coordinate the work in a MULTICENTRE CLINICAL INVESTIGATION or that of several CLINICAL INVESTIGATORS at one site 3.17 case report form a set of documents, designed for complete recording of all relevant patient- and device-related data, as required by the CLINICAL INVESTIGATION PLAN 3
46、.18 clinical investigators brochure a collection of relevant information known prior to the onset of a CLINICAL INVESTIGATION 4 General requirements 4.1 The Declaration of Helsinki and its subsequent amendments shall be the accepted basis for the ethical conduct of CLINICAL INVESTIGATIONS. It shall
47、be applied by all parties involved and at every step in the CLINICAL INVESTIGATION from the first recognition of the need and justification to the publication of results. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:05 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 540:1993 BSI 12-199
48、85 4.2 At all times throughout the CLINICAL INVESTIGATION confidentiality shall be observed by all parties involved. All data shall be secured against unauthorized access (see 5.6.9). 4.3 All agreements shall be recorded in writing and signed by all relevant parties. 4.4 All relevant parties shall b
49、e appropriately qualified to perform their tasks. 4.5 In the event of unforeseen or increased risks to SUBJECTS, suspension or termination of the CLINICAL INVESTIGATION shall be considered. 4.6 The CLINICAL INVESTIGATION shall be designed to collect data to demonstrate whether the DEVICE is suitable for the population(s) for which it is intended. 4.7 A CLINICAL INVESTIGATION shall not start until, as appropriate to national policy, the opinion or approval of the ETHICS COMMITTEE(S) has been received. 4.8 All people involved in CLINICAL INVEST