【国外标准】 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer’s accurate and comprehensive understanding of their internal manufacturing and cleaning processes.5.2 This guide is not intended to provide a detailed plan or road map, but will provide considerations that can be used by the device manufacturer to develop a detailed plan for performing cleaning validation.5.3 In cleaning validation, as with other types of validations, there are multiple ways to achieve a compliant, scientifically sound, and practical cleaning validation program.5.4 There are several reference documents identified in Appendix X3 that describe cleaning validation approaches for non-medical devices (including cleaning for oxygen-enriched environments, pharmaceuticals, and semiconductors). Any of these reference documents could provide guidance for a well-defined process for establishing a manufacturer’s minimum expectation of a specific cleaning validation program.5.5 This guidance specifically targets cleaning validation for medical devices, in-process and at terminal cleaning so that the result is a consistently clean medical device that meets the performance expectations for that device.1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. 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 critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.1.3 Exclusions—The following items / medical devices / processes are excluded from the scope of this document:1.3.1 Reusable medical devices.1.3.1.1 Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices.1.3.2 Cleaning of medical devices in health care facilities.1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.1.4 This standard does not purport to be a replacement for biological safety testing.1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.