Saturday, 5 October 2013

Revisions to sterilization standards


The following sterilization standards have been updated:
  • ISO 11137-2, 2013 Edition, Sterilization of health care products. Radiation. Establishing the sterilization dose
  • ISO 13408-1, Amendment A1 for 2011 Edition, Aseptic processing of health care products. General requirements
  • ISO 13408-6, Amendment A1 for 2011 Edition, Aseptic processing of health care products. Isolator systems
  • ISO 20857, 2013 Edition, Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-2, 3rd Edition, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • ISO 13004, 1st Edition, Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
  • ISO 13408-1, Amendment 1 for 2nd Edition, Amendment 1, Part 1: General Requirements, Aseptic Processing of health care products
  • ISO 17665-3, 1st Edition, Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

The changes made each standard are varied, for example with ISO 11137-2:2013: Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose, the 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.

ISO 11137-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This third edition cancels and replaces the second edition (ISO 11137-2:2012), of which it constitutes a minor revision with the following changes:
  • ·         Addition of the word “and” in 9.1, second paragraph, third sentence;
  • ·         Addition of the word “not” in 10.3.4.1, third paragraph;
  • Correction of the language used to describe requirements for interpretation of results during a verification dose experiment in the second paragraph in 7.2.6.2, 7.3.7.2, 9.2.6.3, 9.3.7.3, 9.4.6.3, and 9.5.7.3.

Posted by Tim Sandle