BSI - British Standards Institution
 |
| BS EN 1041:1998 |
| Information supplied by the manufacturer with medical devices |
 Buy |
BSI Collections
Online subscriptions to multiple documents on various subjects |
Info |
| To speak with an IHS Subject Matter Expert call 1-888-752-0334, outside the US/Canada call 303-397-2892. |
|
|
BS EN 1041:1998 - Information supplied by the manufacturer with medical devices
Foreword
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 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of an identical text or by endorsement, at the latest by August 1998, and conflicting national standards shall be withdrawn at the latest by August 1998.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 Association 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 information 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, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Introduction
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 given 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 devices, 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 given 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 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 appropriate symbols.
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 the 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 supplied.
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 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.
- ISO 31 (all parts), Quantities and units.
- EN 28601, Data elements and interchange formats - Information interchange - Representation of dates and times. (ISO 8601, 1st edition 1988 and technical corrigendum 1:1991).