ISO/WD 8250.2

Cleanliness of medical devices — Process design and test methods

Scope

This document specifies requirements to
• ensure the required cleanliness of medical devices in their delivery state;
• ensure the cleanliness of a medical device which is required for the execution of manufacturing processes.
NOTE 1 There are usually many steps within the manufac¬turing process which are necessary to produce a safe medical device. For some of these steps a defined cleanliness of the medical device is required.
Processes which are carried out after opening the original packaging of the medical device are not covered by this document.
This document does not address the technical implementation of suitable manufacturing and cleaning processes.
This document is not applicable to medical devices or components of medical devices which are located in an area away from the application at the patient and which have no contact to patients.
If it can be demonstrated within a risk analysis that a medical device poses no risk to the patient or the user with respect to its cleanliness (e. g. monitors without user panels or surgical lights without corresponding handles), the further requirements of this document are not applicable to these devices.
This document is not applicable to medical devices that are composed of substances or of combina-tions of substances that are intended to be intro-duced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body.
NOTE 2 The devices addressed in the paragraph above are so-called “substance-based medical devices”, as for example devices in tablet form to moisten the pharyngeal mucosa.
This document is not applicable to medical devices which contain or incorporate tissues or cells, or their derivates, of plantal, animal or human origin.
In addition, this document is not applicable to the following medical devices:
• equipment (e.g. sterilizers and washers/washer-disinfectors);
• liquid or gaseous medical devices;
• absorbable medical devices;
software.