EN 1441:1997
(Main)Medical devices - Risk analysis
Medical devices - Risk analysis
This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.
Medizinprodukte - Risikoanalyse
Diese Norm legt für den Hersteller ein Verfahren fest, mit dem unter Verwendung der verfügbaren Informationen die Sicherheit eines Medizinprodukts, einschließlich der von Produkten zur In-Vitro-Diagnostik oder Zubehör, untersucht wird, indem die mit dem Produkt verbundenen Gefährdungen festgestellt und deren Risiken eingeschätzt werden. Dies ist besonders hilfreich in Bereichen, in denen relevante harmonisierte Normen nicht verfügbar sind oder nicht angewendet werden.
Dispositifs médicaux - Analyse des risques
La présente norme spécifie une procédure qui permet au fabricant d'examiner, en utilisant des informations disponibles, la sécurité d'un dispositif médical, y compris les dispositifs ou accessoires de diagnostic in vitro, en identifiant les dangers et en estimant les risques qui sont associés au dispositif. Elle constitue une aide particulièrement intéressante, notamment dans les domaines où des normes correspondantes sont indisponibles ou inutilisées.
Medical devices - Risk analysis
General Information
- Status
- Withdrawn
- Publication Date
- 21-Oct-1997
- Withdrawal Date
- 26-Feb-2002
- Technical Committee
- CEN/SS S99 - Health, environment and medical equipment - Undetermined
- Drafting Committee
- CEN/SS S99 - Health, environment and medical equipment - Undetermined
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 27-Feb-2002
- Completion Date
- 27-Feb-2002
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Referred By
CEN/TR 17078:2017 - Stationary source emissions - Guidance on the application of EN ISO 16911-1 - Effective Date
- 28-Jan-2026
- Referred By
EN 13725:2003 - Air quality - Determination of odour concentration by dynamic olfactometry - Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 1441:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical devices - Risk analysis". This standard covers: This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.
This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.
EN 1441:1997 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1441:1997 has the following relationships with other standards: It is inter standard links to EN ISO 14971:2000, EN 62282-3-200:2012, EN 62282-3-2:2006, CEN/TR 17078:2017, EN 13725:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1441:1997 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 1441:1997 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.Medical devices - Risk analysisMedizinprodukte - RisikoanalyseDispositifs médicaux - Analyse des risquesMedical devices - Risk analysis11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 1441:1997SIST EN 1441:2000en01-april-2000SIST EN 1441:2000SLOVENSKI
STANDARD
SI
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