EN 1041:2008+A1:2013
(Main)Information supplied by the manufacturer of medical devices
Information supplied by the manufacturer of medical devices
This European 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 !Europäische" 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 européenne" 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
Ta evropski standard določa zahteve za informacije, ki jih mora proizvajalec predložiti medicinskim pripomočkom, kar urejata Direktiva Sveta 90/385/EGS, ki obravnava aktivne medicinske pripomočke za vsaditev, in Direktiva Sveta 93/42/EGS o medicinskih pripomočkih. Ne določa jezika informacij in načina, na katerega je treba informacije predložiti. Namenjen je tudi dopolnitvi posebnih zahtev navedenih direktiv EU o medicinskih pripomočkih z zagotavljanjem navodil o načinu možnega izpolnjevanja določenih zahtev. Če proizvajalec upošteva te načine, priskrbi zagotovilo o skladnosti z ustreznimi bistvenimi zahtevami v zvezi z informacijami, ki jih je treba predložiti. Ta standard ne obravnava zahtev za zagotavljanje informacij za diagnostične medicinske pripomočke in vitro, ki so obravnavane v drugih standardih za označevanje (glej poglavje Literatura).
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 von MedizinproduktenInformations fournies par le fabricant de dispositifs médicauxInformation supplied by the manufacturer of medical devices11.040.01Medicinska oprema na splošnoMedical equipment in general01.110L]GHONHTechnical product documentationICS:Ta slovenski standard je istoveten z:EN 1041:2008+A1:2013SIST EN 1041:2008+A1:2013en,fr,de01-december-2013SIST EN 1041:2008+A1:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1041:2008+A1
September 2013 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:2008 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 and includes Amendment 1 approved by CEN on 11 July 2013.
CEN and CENELEC 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-CENELEC Management Centre or to any CEN and 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2013 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+A1:2013 E
Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended 10 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) . 10 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC) . 16 Annex B (informative)
Guidance on alternative labelling for instructions for use (IFU) . 20 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) . 21 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC) . 22 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC . 23 Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC . 24 Bibliography . 25
This !European 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 documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies." !deleted text" EN ISO 3166-1,!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.
! 1) EN ISO 3166-1 is currently impacted by the corrigendum EN ISO 3166-1:2006/AC:2008, Codes for the representation of names of countries and their subdivisions Part 1: Country codes (ISO 3166-1:2006/Cor 1:2007)." SIST EN 1041:2008+A1:2013
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