BS EN 285:2015 PDF

What is this standard about? It details the requirements and tests for large steam sterilizers. The standard was revised to reference the relationship with Medical Devices Directive 93/42/EEC. Who is this standard for?

Testing laboratories that include sterilizers in their service Medical device manufacturers and installers that include sterilizers in their service Personnel responsible for the maintenance of sterilizers in hospitals and laboratories Personnel responsible for sterilization assurance

Why should you use this standard? It specifies requirements and the relevant tests for large steam sterilizers, primarily used in healthcare for the sterilization of medical devices and their accessories. It applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. The test loads described in this standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. What’s changed since the last update? BS EN 285 was fully revised. Some of the amendments are: