What is BS EN ISO/IEC 17665:2006?
BS EN ISO 17665 sets out the requirements to ensure best practice steam sterilisation of medical equipment. By following this standard’s guidelines, the steam sterilisation process is more likely to produce sterile medical instruments on treatment and improve overall quality control. Although BS EN ISO 17665 is limited to medical equipment, its requirements and guidelines can also be applied to other health care products. It’s important to remember that an accurately controlled sterilisation process is not the only factor that ensures a product is sterile.
How does it work?
To improve the performance of steam sterilisation processes, BS EN ISO 17665 looks at the microbiological status of incoming raw materials. It demonstrates the verification and route control of any cleaning and disinfection procedures used on the product. BS EN ISO 17665 also defines the control of the environment where the product is manufactured, assembled and packaged, as well the management of the personnel’s hygiene.
Who should buy it?
Hospitals
Health care centres
Personnel dealing with steam sterilisation
Manufacturers of steam sterilisers Suppliers of medical equipment
Regulatory bodies
Inspectors
Health and safety officers
Why BSI?
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.
Open preview (PDF)Sterilization of health care products. Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices