BS EN ISO 11137-2 was developed to establish the right sterilisation dose for medical equipment. This latest international standard takes an in-depth look at the methods aligned with the two approaches in ISO 11137-1:2008, including dose setting to get a product specific dose and dose substantiation to confirm a preselected dose of 25kG or 15kGy.
These methods are based on a probability model that demonstrates the inactivation of microbial populations after radiation – such as gamma and ionising radiation – and involve performance tests of sterility on medical instruments.
The establishment of a sterilization dose and the carrying out of sterilization dose audits are activities that are part of process definition and maintaining process effectiveness. The guidance document provides insight into methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
How does it work?
BS EN ISO 11137-2 helps the user to choose and test their medical equipment for the verification of sterilisation doses. It looks at the manner of sampling to ensure quality control and microbiological testing. This standard includes various procedures for dose setting using bioburden information and dose setting using fraction positive information from incremental dosing.
Who should buy it?
• Manufacturers of medical equipment
• Quality assurers
• Persons responsible for sterilising medical equipment
• Regulatory bodies
2) Normative references
3) Terms, definitions and abbreviated terms
4) Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing
5) Selection and testing of product for establishing the sterilization dose
6) Methods of dose establishment
7) Method 1: dose setting using bioburden information
8) Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
10) Sterilization dose audit
11) Worked examples