1.1 This guide provides considerations for validating the cleaning process for single-use and reusable medical devices during initial fabrication and assembly, including reprocessing or modification before initial use. The considerations include, but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues. 1.2 Inclusions 1.2.1 This guide describes the validation of cleaning processes for medical devices to the extent necessary for further processing or the intended use. 1.2.2 This guide includes the cleaning, before first use, of the finished medical device and cleaning at intermediate process steps. 1.3 Exclusions 1.3.1 Reuseable Medical Devices 220.127.116.11 While this guide does not describe validation of cleaning processes after first use for medical devices that are intended and labeled by the manufacturer for reprocessing and reuse, the principals of cleaning validation for reusable medical devices are the same. 18.104.22.168 Such devices include those that are intended for routine reprocessing and reuse (for example, surgical instruments) and certain implant accessories (for example, orthopedic screws) that are provided as parts of sets and are intended and labeled by the manufacturer for reprocessing if not used during a particular procedure. 1.3.2 Cleaning of Medical Devices in Health Care Facilities--This guide does not describe validation of cleaning processes in health care facilities. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsclean line; validation; medical device
Currently, there is no ASTM standard on validating cleaning lines for medical devices. This standard will be useful for OEM medical device manufacturers (particularly quality control), regulatory agencies, and, possibly, medical device reprocessors.Back to Top