EN 12442-2:2000
(Main)Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling
This Part of prEN 12442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 2: Kontrollen der Gewinnung, Sammlung und Handhabung
In diesem Teil der prEN 12442 werden die Anforderungen für die Herkunftsauswahl, Sammlung und Handhabung (inklusive Lagerung und Transport) von Tieren und Geweben festgelegt, die eingesetzt werden zur Herstellung von Medizinprodukte unter Verwendung von Materialien tierischen Ursprungs wobei es sich jedoch nicht um in-vitro Diagnostica handelt. Anmerkung 1: Anforderungen für die Risikoanalyse bei der Verwendung von Materialien tierischen Ursprungs in Medizinprodukte werden in prEN 12442-1 beschrieben.
Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux - Partie 2: Contrôles de l'origine, de la collecte et du traitement
La présente partie du prEN 12442 spécifie les exigences relatives aux contrôle de l'origine, de la collecte et de la manipulation (ce qui comprend le stockage et le transport) d'animaux et de tissus destinés à la fabrication de dispositifs médicaux autres que les dispositifs médicaux de diagnostic in vitro et comportant des matériaux d'origine animale. Note 1: Les exigences en matière d'analyse des risques liés à l'utilisation de matériaux d'origine animale dans des dispositifs médicaux sont décrites dans le prEN 12442-1.
Živalska tkiva in njihovi derivati, uporabljeni v proizvodnji medicinskih pripomočkov – 2. del: Nadzor pri nabavi, zbiranju in ravnanju
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- Withdrawn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
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Frequently Asked Questions
EN 12442-2:2000 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 2: Controls on sourcing, collection and handling". This standard covers: This Part of prEN 12442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.
This Part of prEN 12442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.
EN 12442-2:2000 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 12442-2:2000 has the following relationships with other standards: It is inter standard links to EN ISO 22442-2:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12442-2:2000 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 12442-2:2000 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)
SLOVENSKI STANDARD
01-november-2001
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Animal tissues and their derivatives utilized in the manufacture of medical devices - Part
2: Controls on sourcing, collection and handling
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 2: Kontrollen
...
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