1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1041:1998 The European Standard EN 10
2、41:1998 has the status of a British Standard ICS 01.110; 11.040.01; 11.120.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Information supplied by the manufacturer with medical devicesThis British Standard, having been prepared under the direction of the Health and Environm
3、ent Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1998 BSI 1998 ISBN 0 580 29800 0 BS EN 1041:1998 Amendments issued since publication Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 1
4、041:1998. The UK participation in its preparation was entrusted to Technical Committee CH/68, General terminology, symbols and information provided with medical devices, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries
5、 on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British
6、Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British St
7、andard does not purport 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 cove
8、r, an inside front cover, the EN title page, pages 2 to 16, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitati
9、on in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1041:1998 E EUROPEAN STANDARD EN 1041 NORME EUROPE ENNE EUROPA ISCHE NORM February 1998 ICS 01.110; 11.040.01; 11.120.01 Descriptors: Medical equipment, information, manufacturers, vocabulary, symbols English ve
10、rsion Information supplied by the manufacturer with medical devices Informations fournies par le fabricant avec les dispositifs me dicaux Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts This European Standard was approved by CEN on 18 January 1998. CEN members are bound t
11、o 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-date lists and bibliographical references concerning such national standards may be obtained on application to the Centr
12、al Secretariat 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 t
13、he official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1041:1998 BSI 1998 Foreword
14、This European Standard has been prepared by Technical Committee CEN/TC 257, Symbols and information provided with medical devices and nomenclature for regulatory data exchange, the Secretariat of which is held by SFS. This European Standard shall be given the status of a national standard, either by
15、 publication of an identical text or by endorsement, at the latest by August 1998, and conflicting national standards shall be withdrawn at the latest by August 1998. This European Standard has been prepared under a Mandate given to CEN by the European Commission and the European Free Trade Associat
16、ion and supports essential requirements of EU Directives. For relationship with EU Directives, see informative annexes ZA and ZB, which are integral parts of this standard. This standard is intended to complement the specific requirements of the EU Directives on medical devices relating to the infor
17、mation supplied by the manufacturer for different categories of medical devices. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, Franc
18、e, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Requirements for information to be supplied by the manufacturer 4 An
19、nex A (informative) Bibliography 5 Annex B (informative) Requirements and guidance for active implantable medical devices 6 Annex C (informative) Requirements and guidance for medical devices 9 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provis
20、ions of Council Directive 90/385/EEC relating to active implantable medical devices 15 Annex ZB (informative) Clauses of this European Standard addressing essential requirements or other provisions of Council Directive 93/42/EEC concerning medical devices 16Page 3 EN 1041:1998 BSI 1998 Introduction
21、This standard is applicable to medical devices generally, but it should be noted that other European Standards may specify additional information requirements for particular types of medical devices. The requirements of this standard are given in clause 4. Additional information and guidance are giv
22、en in the annexes. Annex A gives a short bibliography of documents related to information, including labelling, supplied by the manufacturer. Annexes B and C reproduce, for convenience of use, the relevant text of the EU Directives relating to active implantable medical devices, and to medical devic
23、es, respectively. Guidance is given in annexes B and C to assist manufacturers to achieve compliance with the requirements of those texts. For ease of use, a two column system of presentation has been adopted for annexes B and C. The first column reproduces verbatim the information requirements as g
24、iven in annex 1 of the Council Directives concerning medical devices. The second column contains, where appropriate, further guidance for manufacturers as to ways in which compliance with the particular information requirements of the Directives may be achieved. This guidance is not to be considered
25、 as the obligatory or only way of achieving compliance with the requirements of the Directive; alternative ways may be acceptable. In order to facilitate the presentation of information and to reduce the need for translation into numerous languages, consideration should always be given to using appr
26、opriate symbols. 1 Scope This standard specifies requirements for the information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement th
27、e specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be
28、 supplied. 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 t
29、o 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. ISO 31 (all parts), Quantities and units. EN 28601, Data elements and interchange forma
30、ts Information interchange Representation of dates and times. (ISO 8601, 1st edition 1988 and technical corrigendum 1:1991). 3 Definitions For the purposes of this standard, the following definitions apply: 3.1 batch; lot a defined quantity of starting material, packaging material or product process
31、ed in one process or series of processes 3.2 batch code; lot number; batch number; lot code a distinctive combination of numbers and/or letters which specifically identifies a batch NOTE This definition is as given for batch or lot number in the Rules Governing Medicinal Products in the European Com
32、munity, Volume IV, Guide to Good Manufacturing Practice for Medicinal Products. 3.3 information supplied by the manufacturer with the medical device all written, printed or graphic matter: a) on a medical device or any of its containers or wrappers; or b) accompanying a medical device; relating to t
33、he identification, technical description and use of the medical device, but excluding shipping documentation and promotional material. The information comprises the details on the label and the data in the instructions for use. The instructions for use may be included on the label. 3.4 medical devic
34、e any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviati
35、on of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement 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
36、by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means EN 46001 NOTE This definition is as given in the Council Directive concerning medical devices (93/42/EEC), Article 1, paragraph 2 (a).Page 4 EN 1041:1998 BSI 1998 4 Requirements for informat
37、ion to be supplied by the manufacturer NOTE The medical devices Directives stipulate the legal requirements for information supplied by the manufacturer. These are reproduced verbatim in the informative annex B for active implantable devices and informative annex C for medical devices. Due considera
38、tion should be given to the guidance in these annexes. Product related standards may require additional information to be supplied. Product area standards may also require additional information, e.g. clause 6 of the various parts of EN 60601 for medical electrical equipment. 4.1 Requirements 4.1.1
39、Information supplied by the manufacturer and intended for direct visual recognition shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device. NOTE 1 The inf
40、ormation presented should be understandable by the intended user and/or other persons, where appropriate. NOTE 2 If there is insufficient space on the container or the device, the relevant information may be given on an insert, accompanying document or on the next layer of packaging, as applicable.
41、The recognition of certain markings on small or specialized devices may require the use of methods other than visual, for example, electronic. 4.1.2 Any symbols used in the information supplied by the manufacturer with the medical devices shall either: a) conform to those specified in harmonized sta
42、ndards, or b) in areas for which no harmonized standards exist, have their meanings explained in the information supplied by the manufacturer with the device. NOTE Examples of harmonized standards are EN 980 and EN 60601. 4.1.3 Any identification colours used in the information supplied by the manuf
43、acturer with the medical devices shall either: a) conform to those specified in relevant harmonized standards, e.g. medical gas cylinders; or b) where no harmonized standard exists, be described together with their meanings in the information supplied by the manufacturer with the device. NOTE Refere
44、nce to standards which include colour coding is given in annex A. 4.1.4 The information supplied by the manufacturer shall not be presented in such a manner that it obscures other essential information. NOTE The information supplied by the manufacturer should not be presented in such a manner that i
45、t may be confused with other essential information. 4.1.5 Any units of measurement shall be expressed in SI units as specified in ISO 31, or other legal units. NOTE 1 Attention is drawn to Council Directive 80/181/EEC as amended, see annex A, and to ISO 1000 which gives further guidance on the appli
46、cation of SI units. NOTE 2 This requirement does not preclude the additional use of other units as allowed by harmonized standards. 4.1.6 As far as is practicable and appropriate, the information needed to use the device safely shall be set out on the device itself and/or on the packaging for each u
47、nit, or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information shall be set out in the leaflet supplied with the device(s). 4.1.7 User adjustable controls shall have their function clearly specified. 4.1.8 Any detachable component, intend
48、ed by the manufacturer to be used separately from the original device, shall be identified by its batch code, or by other appropriate means. 4.1.9 The address of the manufacturer shall be provided in sufficient detail to enable contact to be established. NOTE Specific legal requirements apply to dev
49、ices imported into the European Union, see annex C, 13.3a). 4.1.10 Any date shall be expressed in the format YYYY-MM-DD, or YYYY-MM, or YYYY, in accordance with EN 28601. NOTE The choice of format will be determined by the requirements of the relevant Directive(s) and the specific nature of the device itself.Page 5 EN 1041:1998 BSI 1998 Annex A (informative) Bibliography EN 556, Sterilization of medical devices Requirements for medical devices to be labelled “Sterile”. EN 980, Graphical symbols for use in the labelling of medical devices. EN 1089-3
