WHO Medical Device Technical Series: 2011.World Health Organization. Medical device technical series: introduction to medical equipment inventory management. Geneva, Switzerland: WHO Press; 2011. p. 1-31.Introduction to Medical Equipment Inventory Management, World Health Org., Geneva, Switzerland, 2...
medicaldevices.Proposetoinitiateactionplanforpatientsafetyrelatedtomedicaldevicesanddiscussthepathway andmeasurestofurtherensurepatientsafetyandstrengthensafetymanagementintheclinicaluseofmedicaldevices, inconjunctionwithpromotinghigh-qualitydevelopmentofhospitals.
• documentation, premises, equipment; •文件、设施、设备; • personnel qualification and training; •人员资质和培训; • quality management and risk management; •质量管理和风险管理; •life cycle approach; •生命周期方法; • control strategy; ...
9.4 Where the review and comparison identify any gaps or differences, appropriate action should be taken. This may include the adaptation of existing equipment or acquisition of new equipment. Such action should be taken by following a change management procedure which should be documented. 如果审查...
• documentation, premises, equipment; •文件、设施、设备; • personnel qualification and training; •人员资质和培训; • quality management and risk management; •质量管理和风险管理; •life cycle approach; •生命周期方法; • control strategy; and ...
• documentation, premises, equipment; •文件、设施、设备; • personnel qualification and training; •人员资质和培训; • quality management and risk management; •质量管理和风险管理; •life cycle approach; •生命周期方法; •...
1.3. This document replaces the WHOGuidanceon good data and recordmanagementpractices(Annex 5, WHO Technical Report Series, No. 996, 2016) (1). 本文件取代了《WHO良好数据和记录管理规范指南》(WHO技术报告系列,No. 996, 2016,附件5)(1)。
implications for China's medical equipment industry to further promote the development of AIMD. At the same time of analysis and comparative research, it puts forward some suggestions on strengthening the generation of evidence in the AIMD life cycle management(LCM) in China's medical equipment ...
4.Qualityriskmanagement 质量风险管理 5.Sanitationandhygiene 清洁卫生 6.Qualificationandvalidation 确认与验证 7.Outsourcedactivities 外包活动 8.Self-inspectionandqualityaudits 自检和质量审计 9.Personnel 人员 10.Training 培训 11.Premises 厂房 12.Equipmentandinstruments ...
Pharmaceutical Product 时间和温度敏感的药品 UPS Uninterrupted Power Supply 不间断电源 WHO TR961A9 技术补充文件之七:温控存贮区域的确认 翻译Julia 3/31 Glossary 术语 (略) Auxiliary equipment: Equipment mostly used in conjunction with the equipment to be qualified but not included in the qualification ...