ISO/AWI 8250

Cleanliness of medical devices — Process design and test methods ISO/AWI 8250

Scope

This document specifies requirements to
― ensure the cleanliness of a medical device which is required for the execution of subsequent manufacturing processes,
― ensure the required cleanliness of medical devices in their delivery state.
NOTE 1 There are usually many steps within the manufacturing process which are necessary to produce a safe medical device. For some of these steps a defined cleanliness of the medical device is required.
This document gives guidance with respect to the approach regarding:
— the risk analysis regarding manufacturing processes and applied manufacturing aids (including cleaning processes and cleaning detergents, if cleaning is applied) and cleanliness (see Clause 5);
— the validation of a process developed to reach a defined cleanliness; (see Clause 7);
— the establishment of acceptance criteria for this validation (see Clause 8);
— the selection of suitable test methods (see Clause 9).
This document does not address the technical implementation of suitable manufacturing and cleaning processes.
This document does not apply to
— processes which are carried out after opening the original packaging of the medical device. In particular, it does not apply to cleaning, disinfection and/or sterilisation applied to (repeated) processing of single-use or reusable medical devices in a home use or healthcare setting,
— the activities to be carried out by manufacturers and users of medical devices intended to be conditioned prior to use to demonstrate suitability for effective cleaning, disinfection and/or sterilisation during processing,
— 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,
— devices, for which 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),
— medical devices that are composed of substances or of combinations of substances that are intended to be introduced 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,
— materials which can absorb contaminants like hydrogel materials and naturally occurring derived materials, including collagen, chitin/chitosan, alginic acid, hyaluronic acid, etc.,
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, or creams applied topically on the skin.
— medical devices or medical device components which contain or incorporate tissues or cells, or their derivatives, of herbal, animal, or human origin.
— the following medical devices:
― equipment (e.g., sterilizers and washers/washer-disinfectors);
― gas path devices (e.g., respiratory masks, ventilators, CPAP);
― liquid or gaseous medical devices;
― absorbable medical devices;
― software.
NOTE 3 Cleanliness of the medical device can be controlled by manufacturing in a clean environment and with clean processes (where all manufactured steps are conducted in a clean environment and no manufacturing aids are used). In this case, the cleaning of the medical device before packaging may not be required but the risk analysis defined in this document can apply.