Standard

NS-EN ISO 11607-1:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 11607-1:2020

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Abstract

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-06
  • Version: 1
  • Document type: NAT
  • ICS 11.080.30
  • National Committee SN/K 108

Legal references

EU law: 2007/47/EC, 90/385/EEC, 93/42/EEC

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