1.1 本指南提供了在初始制造和组装期间，在初始使用之前验证医疗器械清洁过程的注意事项。经过验证的清洁工艺对于实现功能的一致性和生物相容性的一致性非常重要。考虑因素包括但不限于:验证方法、设备设计、程序和文件、分析方法、取样、限值制定和其他问题。 1.2 包含内容: 1.2.1 本指南描述了医疗器械关键清洁工艺的验证，以在包装前将污染物降低到可接受的水平。 1.3 除外责任- 以下项目/医疗器械/工艺不在本文件范围内: 1.3.1 可重复使用的医疗器械。 1.3.1.1 可重复使用医疗器械的清洁操作验证不在本标准指南的范围内。虽然清洁可重复使用的医疗器械超出了本指南的范围，但本指南中概述的许多原则可能适用于可重复使用器械的清洁操作验证。 1.3.2 清洁医疗设施中的医疗设备。 1.3.2.1 患者/医疗机构清洁流程的验证不在本标准指南的范围内。 1.4 本标准并不打算取代生物安全测试。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 5.1 本指南描述了验证医疗设备清洁系统的方法。它基于制造商对其内部制造和清洁过程的准确和全面了解。 5.2 本指南无意提供详细的计划或路线图，但将提供设备制造商在制定详细的清洁验证计划时可以考虑的因素。 5.3 在清洁验证中，与其他类型的验证一样，有多种方法可以实现合规、科学合理和实用的清洁验证程序。 5.4 以下是一些参考文件 附录X3 描述了非- 医疗设备（包括富氧环境、药品和半导体的清洁）。任何这些参考文件都可以为明确定义的过程提供指导，以确定制造商对特定清洁验证程序的最低期望。 5.5 本指南专门针对医疗器械、过程中和终端清洁的清洁验证，以确保医疗器械始终保持清洁，满足该器械的性能预期。

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. ====== Significance And Use ====== 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.