标准规范-国际标准-ANSI

ANSI AAMI ST79 and A1 and A2 and A3 and A4-2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.pdf
ANSI AAMI ST77-2013 Containment devices foe reusable medical device sterilization《可再利用的医疗设备杀菌用密封装置》.pdf
ANSI AAMI ST72-2011 Bacterial endotoxin.Test methodologies routine monitoring and alternatives to batch testing.pdf
ANSI AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled STERILE 《医疗装置的消毒.贴有 已消毒 标签的产品要求》.pdf
ANSI AAMI ST58-2013 Chemical sterilization and high-level disinfection in health care facilities《医疗保健设施中戊二醛基产品的安全使用和处理》.pdf
ANSI AAMI ST41-2008 Ethylene oxide sterilization in health care facilities Safety and effectiveness《卫生保健设施中的环氧乙烷灭菌 安全和效能》.pdf
ANSI AAMI ST15883-3-2012 Washer-disinfectors - Part 3 Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers《洗涤消毒器.第3部分 对人类废弃物容器进行.pdf
ANSI AAMI ST15883-2-2013 Washer-disinfectors.Part 2 Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments anesthetic equipment bowl.pdf
ANSI AAMI ST15883-1-2009 Washer-disinfectors.Part 1 General requirements terms and definitions and tests.pdf
ANSI AAMI RD47-2008 Reprocessing of hemodialyzers《人造肾脏的再生》.pdf
ANSI AAMI RD17-2007 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers hemodiafilters and hemofilters《心血管植入物和人造器官.血液透析器、血液透析过滤器和血液过滤器用体外.pdf
ANSI AAMI PB70-2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.pdf
ANSI AAMI NS4-2013 Transcutaneous electrical stimulators《经皮的电刺激器》.pdf
ANSI AAMI ISO TIR24971-2013 Medical devices - Guideance on the application of ISO 14971.pdf
ANSI AAMI ISO TIR23810-2012 Cardiovascular implants and artificial organs.Checklist for preoperative extracorporeal circulation equipment setup.pdf
ANSI AAMI ISO TIR22442-4-2010 Medical devices utilizing animal tissues and their derivatives.Part 4 Principles for elimination and or inactivation of transmissible spongiform encep.pdf
ANSI AAMI ISO TIR19218-2-2012 Medical devices - Hierarchal coding structure for adverse events - Part 2 Evaluation codes.pdf
ANSI AAMI ISO TIR19218-1-2011 Medical devices Hierarchical coding structure for adverse events Part 1 Event-type codes.pdf
ANSI AAMI ISO TIR15499-2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process.pdf
ANSI AAMI ISO TIR13004-2013 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose Method VDmaxSD.pdf
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