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Normas DIN – AENOR
DIN EN 868-8:2007-10

DIN EN 868-8:2007-10

Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version pEN 868-8:2007

Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 8: Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 - Anforderungen und Prüfverfahren; Deutsche Fassung prEN 868-8:2007

Fecha Anulación:
2019-09 /Withdrawn
Equivalencias internacionales:

prEN 868-8 (2007-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN 868-8:2009-09

Resumen:
This Part of EN 868 provides test methods and values for re-usable containers for steam sterilization. This part of EN 868 introduces no additional requirements to the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The containers specified in this part of the standard are intended to be used as a packaging system during the sterilization of medical devices in steam sterilizers conforming to EN 285 and the subsequent transportation and storage of those devices. Note 1: When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e. g. operating temperature. Note 2: When goods are required to be multiply wrapped in order to fulfil the general requirements, they should first be packaged in a sterilization packaging material (e. g. a material as specified in other parts of this series of standards).
Keywords:
Applications, Containers, Hygiene, Inspection, Marking, Materials, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Packages, Packaging material, Packaging tests, Products, Re-usable, Safety, Safety requirements, Specification (approval), Steam sterilization, Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Storage, Testing, Transport packing, Validation
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