EN 12442-1:2000
(Main)Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Analyse und Handhabung von Risiken
Dieser Teil der prEN 12442 bezieht sich auf Medizinprodukte (mit Ausnahme der Medizinprodukte für die in-vitro-Diagnostik) hergestellt unter Verwendung nicht lebensfähiger oder abgetötetertierischer Gewebe oder deren Derivaten. Er gibt in Verbindung mit EN 1441, ein Verfahren an, um unter Verwendung verfügbarer Informationen die Sicherheit derartiger Produkte zu untersuchen, indem die Gefahren identifiziert und die Risiken abgeschätzt werden, die mit dem Produkt verbunden sind (Risikoanalyse).
Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux - Partie 1: Analyse et gestion des risques
La présente partie du prEN 12442 s'applique aux dispositifs médicaux (à l'exclusion des dispositifs médicaux de diagnostic in vitro), fabriqués en utilisant des tissus animaux ou des produits dérivés de tissus animaux, qui sont non viables ou rendus non viables. Associée à l'EN 1441 et en se fondant sur les renseignements disponibles, elle décrit un mode opératoire permettant d'étudier la sécurité de ces dispositifs en identifiant les dangers et en évaluant les risques qui y sont associés (analyse des risques).
Živalska tkiva in njihovi derivati, uporabljeni v proizvodnji medicinskih pripomočkov – 1. del: Analize in obvladovanje tveganja
General Information
- Status
- Withdrawn
- Publication Date
- 19-Sep-2000
- Withdrawal Date
- 14-Dec-2007
- Technical Committee
- CEN/TC 316 - Medical devices utilizing tissues
- Drafting Committee
- CEN/TC 316 - Medical devices utilizing tissues
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Dec-2007
- Completion Date
- 15-Dec-2007
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 12442-1:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk". This standard covers: This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).
This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).
EN 12442-1:2000 is classified under the following ICS (International Classification for Standards) categories: 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12442-1:2000 has the following relationships with other standards: It is inter standard links to EN ISO 22442-1:2007, EN ISO 16671:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12442-1:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. 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 12442-1:2000 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)
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Animal tissues and their derivatives utilized in the manufacture of medical devices - Part
1: Analysis and management of risk
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 1: A
...
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