Introduction

Small steam sterilizers are widely used for medical purposes, e.g. in general medical practices, dentistry, facilities for personal hygiene and beauty care and also veterinary practices. They are also used for materials and equipment, which are likely to come into contact with blood or body fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers. The very specific sterilizer loads used within these fields of application call for different performance requirements for the sterilization cycles and different corresponding test methods.

This European Standard specifies the general requirements for small steam sterilizers and test methods for specified sterilizer loads according to Table 1. These loads include unwrapped solid products, full porous load, small porous load, small porous items, hollow loads A, hollow loads B, single wrapped products and double wrapped products. The performance tests specified in this standard can also be used by device manufacturers to specify the appropriate performance for decontamination processes according to the requirements for information to be given by medical device manufacturers according to EN ISO 17664:2004. This will enable users to identify the specific sterilizer performance required to safely process their devices.

Table 1 — Types of sterilization cycles

Type	Description of intended use
B	The sterilization of all wrapped or non-wrapped, solid, hollow load products type A and porous products as represented by the test loads in this standard.
N	The sterilization of non wrapped solid products.
S	The sterilization of products as specified by the manufacturer of the sterilizer including non wrapped solid products and at least one of the following: porous products, small porous items,hollow load products type A, hollow load products B, single wrapped products, multiple-layer wrapped products.

NOTE 1 The description identifies ranges of products and test loads.

NOTE 2 Non wrapped sterilized instruments are intended either for immediate use or for non sterile storage, transport and application (e.g. to prevent cross infection).

The performance requirements specified in this document are not intended for the process to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prior decontamination programme.

It is essential that the sterilizer and associated equipment is used only for the sterilization of the type of products for which it is designed. The choice of sterilizer, sterilization cycle or quality of services provided can be inappropriate for a particular load. Therefore the suitability of a sterilization procedure for a particular product needs to be verified by validation.

BS EN 13060:2004+A2:2010

Small steam sterilizers

Published:

3 Aug 2005

Withdrawn:

31 Dec 2014