标准规范-国际标准-ANSI

ANSI AAMI ISO 13408-6-2005 A1-2013 Aseptic processing of health care products - Part 6 Isolator systems - Amendment 1.pdf
ANSI AAMI ISO 13408-1-2008 Aseptic processing of health care products - Part 1 General requirements《保健产品的防腐处理.第1部分 一般要求》.pdf
ANSI AAMI ISO 13022-2012 Medical products containing viable human cells.Application of risk management and requirements for processing practices.pdf
ANSI AAMI ISO 11658-2012 Cardiovascular implants and extracorporeal systems.Blood tissue contact surface modifications for extracorporeal perfusion systems.pdf
ANSI AAMI ISO 11137-2-2013 Sterilization of health care products.Radiation.Part 2 Establishing the sterilization dose《保健产品的灭菌.辐射.第2部分 杀菌剂量的确定》.pdf
ANSI AAMI ISO 10993-6-2007 Biological evaluation of medical devices - Part 6 Tests for local effects after implantation《医疗装置的生物学评估.第6部分 植入后局部效应用试验》.pdf
ANSI AAMI ISO 10993-5-2009 Biological evaluation of medical devices - Part 5 Tests for in vitro cytotoxicity《医疗器械的生物学评价.第5部分 体外细胞毒性试验》.pdf
ANSI AAMI ISO 10993-17-2002 Biological evaluation of medical devices - Part 17 Establishment of allowable limits for leachable substances《医疗器械的生物学评估.第17部分 可滤出物质允许极限值的确定》.pdf
ANSI AAMI ISO 10993-12-2012 Biological evaluation of medical devices.Part 12 Sample preparation and reference materials.pdf
ANSI AAMI ISO 10993-12-2007 Biological evaluation of medical devices - Part 12 Sample preparation and reference materials 《医疗装置的生物学评估.第12部分 样品制备和参考材料》.pdf
ANSI AAMI ISO 10993-1-2009 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process《医疗器械的生物学评价.第1部分 风险管理系统内的评价与测试》.pdf
ANSI AAMI IEC TIR80001-2-4-2012 Application of risk management for IT Networks incorporating medical devices.Part 2-4 General implementation guidance for healthcare delivery organi.pdf
ANSI AAMI IEC TIR80001-2-3-2012 Application of risk management for IT Networks incorporating medical devices.Part 2-3 Guidance for wireless networks.pdf
ANSI AAMI IEC TIR80001-2-2-2012 Application of risk management for IT Networks incorporating medical devices.Part 2-2 Guidance for the disclosure and communication of medical devic.pdf
ANSI AAMI IEC TIR80001-2-1-2012 Application of risk management for IT Networks incorporating medical devices.Part 2-1 Step by step risk management of medical IT-networks Practical .pdf
ANSI AAMI IEC TIR62348-2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1 2005 and mapping of the clauses of IEC 60601-1 2005 to the previo.pdf
ANSI AAMI IEC TIR61289-2011 High frequence surgical equipment.Operation and maintenance.pdf
ANSI AAMI IEC TIR 62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals of new requirements《标准IEC 60601-1的第2版中未提到的安全方面的考虑和对新要求的.pdf
ANSI AAMI IEC 60601-2-47-2012 Medical electrical equipment.Part 2-47 Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic syste.pdf
ANSI AAMI IEC 60601-2-27-2011 Medical electrical equipment.Part 2-27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equip.pdf
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