EN 1041:2008
(Main)Information supplied by the manufacturer of medical devices
Information supplied by the manufacturer of medical devices
This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
Die vorliegende Norm legt Anforderungen an Informationen fest, die von einem Hersteller für Medizinprodukte nach der EU-Richtlinie 90/385/EWG zu aktiven implantierbaren medizinischen Geräten und EU-Richtlinie 93/42/EWG zu Medizinprodukten zur Verfügung zu stellen sind. Es werden weder die verwendete Sprache für diese Informationen noch die Mittel festgelegt, mit denen die Informationen zu geben sind. Es ist ferner beabsichtigt, die besonderen Anforderungen der genannten EU-Richtlinien zu Medizinprodukten durch die Bereitstellung einer Anleitung zu ergänzen, wie bestimmte Anforderungen erfüllt werden können. Wenn diese Hinweise von einem Hersteller befolgt werden, so liefern sie eine Annahme der Übereinstimmung mit den relevanten grundlegenden Anforderungen hinsichtlich der bereitzustellenden Information.
Die vorliegende Norm schließt keine Anforderungen an die Bereitstellung von Informationen für In-vitro-Diag¬nostika ein, die von anderen genannten Normen abgedeckt werden (siehe Literaturhinweise).
ANMERKUNG Sofern nationale Umstellungen der Richtlinien die Mittel festlegen, mit denen Informationen zur Verfügung zu stellen sind, führt die vorliegende Norm nicht zu einer teilweisen Aufhebung dieser Anforderungen für das bestimmte Land.
Informations fournies par le fabricant de dispositifs médicaux
La présente norme spécifie les exigences concernant les informations à fournir par un fabricant de dispositifs médicaux d’après la réglementation dictée par la Directive du Conseil 90/385/CEE relative aux dispositifs médicaux implantables actifs et par la Directive du Conseil 93/42/CEE concernant les dispositifs médicaux. Elle ne spécifie pas la langue à utiliser pour ces informations ni les moyens par lesquels les informations sont fournies. Elle a également pour but de venir compléter les exigences spécifiques des Directives UE sur les dispositifs médicaux citées en donnant des indications sur la manière dont certaines exigences peuvent être satisfaites. Si un fabricant suit ces indications, celles-ci laissent à présumer de la conformité aux exigences essentielles relatives à la fourniture d'informations.
La présente norme ne couvre pas les exigences concernant la fourniture d’informations pour les dispositifs médicaux de diagnostic in vitro qui font l'objet d'autres normes d'étiquetage (voir Bibliographie).
NOTE Lorsque des transpositions nationales des directives précisent les moyens par lesquels les informations doivent être fournies, la présente norme ne propose pas de dérogation à ces exigences pour un pays particulier.
Informacije, ki jih proizvajalec priloži medicinskim pripomočkom
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Bereitstellung von Informationen durch den Hersteller eines MedizinproduktsInformations fournies par le fabricantavec les dispositifs médicauxInformation supplied by the manufacturer with medical devices11.040.01Medicinska oprema na splošnoMedical equipment in general01.110L]GHONHTechnical product documentationICS:Ta slovenski standard je istoveten z:EN 1041:2008SIST EN 1041:2008en,fr,de01-oktober-2008SIST EN 1041:2008SLOVENSKI
STANDARDSIST EN 1041:20001DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1041
August 2008 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:1998
English version
Information supplied by the manufacturer of medical devices
Informations fournies par le fabricant de dispositifs médicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European Standard was approved by CEN on 4 July 2008.
CEN andCENELEC 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-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC 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 and/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of 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 United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:rue de Stassart, 36
B-1050 Brussels rue de Stassart, 35
B-1050 Brussels© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 1041:2008 E SIST EN 1041:2008
Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended.9 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC).9 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC).15 Annex B (informative)
Guidance on alternative labelling for instructions for use (IFU).19 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC).20 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC).21 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC.22 Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC.23 Bibliography.24
Foreword This document (EN 1041:2008) has been prepared by Technical Committee CEN/CLC TC 3 “Quality management and corresponding general aspects for medical devices”, the secretariat of which is held by NEN. This European Standard EN 1041:2008 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2009 and conflicting national standards shall be withdrawn at the latest by August 2011. This document supersedes EN 1041:1998. This document 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 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B. Annex A provides practical guidance about the implementation of the essential requirements of the applicable Directives. For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
1 Scope This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country. 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 the referenced document (including any amendments) applies. EN 980, Symbols for use in the labelling of medical devices EN ISO 3166-1, Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2006) ISO 639-1, Codes for the representation of names of languages – Part 1: Alpha-2 Code ISO 1000, SI units and recommendations for the use of their multiples and of certain other units ISO 8601, Data elements and interchange formats – Information interchange – Representation of dates and times CEN/TR 15133, Nomenclature - Collective terms and codes for groups of medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 batch; lot defined amount of material or a number of devices, including finished product and accessories, that is processed in one process or a series of related processes
NOTE The defined amount of material or number of devices will normally be associated with a unique statement of conformity to a defined quality specification. 3.2 batch code; lot number; batch number; lot code unique identifier associated with a single batch or lot (see 3.1) SIST EN 1041:2008
all material, however provided, relating to the identification, technical description and use of a medical device that is intended to ensure the safe, effective and compliant use of the device NOTE Shipping documents and promotional material are excluded from this definition when identification, technical description and use of a medical device are not intended to ensure the safe, effective and compliant use of the device.
3.5 medical device any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation 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
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