Standard

NS-EN 868-8:1999

Withdrawn

Note: This standard has a new edition: NS-EN 868-8:2018

Corrigendums and amendments are bought separately.

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Abstract

This Part of the series of EN 868 provides examples of particular requirements and test methods for re-usable containers for steam sterilization. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 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 steriliz-ation 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 tempera-ture. 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).

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.080
  • ICS 11.080.30
  • ICS 55.040
  • ICS 55.120
  • National Committee SN/K 108

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