BS EN ISO 11137-2 was developed to establish the right sterilisation dose for medical equipment. This 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.
BS EN ISO 11137-2 helps the user to choose and test their medical equipment for the verification of sterilisation doses. It also looks at the manner of sampling to ensure quality control, as well as microbiological testing. This standard includes various procedures for dose setting using bioburden information (Method 1), and dose setting using fraction positive information from incremental dosing (Method 2).
We are global, we’re independent and we’re a trusted service provider to 80,000 businesses. We operate in 147 countries and are the number one certification body in the UK and US. We created 85% of our portfolio because we know standards and we know your business. We’re leaders and we can make you one too.
EN ISO 11137-2:2007/AC:2009
ISO 11137-2:2006/COR 1:2009