BS ISO 19227:2018规定了骨科植入物（以下简称植入物）的清洁度要求，以及基于风险管理过程的清洁过程验证和控制的测试方法。本文件未规定其他国际标准所涵盖的包装或灭菌要求。本文件适用于过程中清洁和最终清洁。本文件不适用于液体或气体植入物。本文件不适用于由用户执行或由用户负责的清洁过程。交叉引用:ISO 10993-1ASTM D7066-04ISO 10993-5ISO 11737-1ISO 9377-2NF S94-091ISO 10993-12ASTM F3127ISO 3951-2IMDRF SG3/N99-10:2004AAMI ST72ISO 14971EN 13018ISO 3951-1EN 1484ASTM F2459ISO 10993-17ISO 14644ISO 2859- 1ISO/IEC 17025ISO 13485ICH Q3DAAMI TIR42:2010购买本文件时提供的所有现行修订版均包含在购买本文件中。

BS ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.This document does not specify requirements for packaging or sterilization which are covered by other International Standards.This document applies to in-process cleaning and final cleaning.This document does not apply to liquid or gaseous implants.This document does not apply to cleaning processes performed by the user or under the responsibility of the user.Cross References:ISO 10993-1ASTM D7066-04ISO 10993-5ISO 11737-1ISO 9377-2NF S94-091ISO 10993-12ASTM F3127ISO 3951-2IMDRF SG3/N99-10:2004AAMI ST72ISO 14971EN 13018ISO 3951-1EN 1484ASTM F2459ISO 10993-17ISO 14644ISO 2859-1ISO/IEC 17025ISO 13485ICH Q3DAAMI TIR42:2010All current amendments available at time of purchase are included with the purchase of this document.