EN 1041:1998
(Main)Information supplied by the manufacturer with medical devices
Information supplied by the manufacturer with medical devices
This standard specifies requirements on 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.
Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts
Diese Norm legt Informationen fest, die ein Hersteller nach der einschlägigen Anforderungen der EU-Richtlinien für verschiedene Kategorien von Medizinprodukten bereitstellen muß. Die Sprache, in der solche Informationen zu geben sind, wird nicht festgelegt. Es ist beabsichtigt, daß sie die besonderen Anforderungen der EG-Richtlinien über Medizinprodukte dadurch ergänzt, daß sie angibt, wie gewisse Anforderungen erfüllt werden können.
Informations fournies par le fabricant avec les dispositifs médicaux
La présente norme spécifie les informations qui doivent être fournies par le fabricant pour les différentes catégories de dispositifs médicaux, conformément aux Directives de l'UE pertinentes. Elle ne spécifie pas la langue dans laquelle ces informations doivent être rédigées. Elle est destinée à compléter les exigences particulières des Directive de l'UE relatives aux dispositifs médicaux en spécifiant les moyens qui permettent de satisfaire à certaines exigences.
Informacije, ki jih proizvajalec priloži medicinskim pripomočkom
General Information
- Status
- Withdrawn
- Publication Date
- 17-Feb-1998
- Withdrawal Date
- 05-Aug-2008
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 06-Aug-2008
- Completion Date
- 06-Aug-2008
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 1041:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Information supplied by the manufacturer with medical devices". This standard covers: This standard specifies requirements on 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.
This standard specifies requirements on 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.
EN 1041:1998 is classified under the following ICS (International Classification for Standards) categories: 01.110 - Technical product documentation; 11.040.01 - Medical equipment in general; 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1041:1998 has the following relationships with other standards: It is inter standard links to EN 1041:2008, EN 14931:2006, EN ISO 16671:2003, EN ISO 18777:2009, EN ISO 18779:2005, EN ISO 18778:2009, EN ISO 16672:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1041:1998 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1041:1998 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 fabricant avec 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 1041:1998SIST EN 1041:2000en01-januar-2000SIST EN 1041:2000SLOVENSKI
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...