Standard

NS-EN ISO 11137-2:2015

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Abstract

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Document information

  • Standard from SN
  • Published:
  • Edition: 2015-06
  • Version: 1
  • Document type: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Legal references

EU law: 93/42/EEC, 90/385/EEC, 2017/746, 2017/745, 98/79/EC

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