1. Scope
The increased complexity and capabilities of medical devices have revolutionized the practice of medicine. However, the ability to clean manufacturing residues from new implants and other devices and the ability to appropriately reprocess reusable devices such devices has grown more difficult with increasingly complex devices. Incidents of reusable medical devices that had retained patient material might have been reduced if the reported devices had been designed with cleanability in mind. The primary objective of this document is to assist biomedical engineers in the design process by providing design criteria that promote the cleaning and removal of contaminants, with the end-goal being a design process that includes cleanability as a design endpoint. This standard will detail and illustrate the basic physical characteristics of medical devices that promote the retention of manufacturing residues and for reusable devices, the retention of patient material, as well as those characteristics which ease the process of removing contamination.
Users will be designers of medical devices. Depending on the final document, it may be recognized by the FDA.
Keywords
cleanliness
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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