Make your own free website on Tripod.com

       首頁 向上                    

    中華民國中歐產業研究學會

 

 

 

 

您若有任何問題請與我們聯絡, 我們將在24小時之內給您回覆 

             本會所蒐集的ATSM/ANSI /UL 國際標準
ANSI/AAMI/IEC 62304:2006 Medical Device Software— Software life processes
ANSI/AAMI/ISO 81060-1:2007 Non-invasive sphygmomanometers— Part 1: Requirements and test methods for non-automated measurement type
ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers— Part 2: Clinical validation of automated measurement type
ANSI/AAMI/ISO 81060-2-30:2009 Non-invasive sphygmomanometers— Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
D 1708-02a Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
D 3570: 00 Standard specification for Rubber Examination Gloves
D 3577: 00 Standard specification for Rubber Surgical Gloves
D 5151: 99 Standard Test Method for Detection of Holes in Medical Gloves
D 5250: 00 Standard specification for Poly (vinyl chloride) Gloves for Medical Application
D 5466: 01 Standard Test Method for Determination of Volatile Organic Chemicals in Atomospheres
D 5712: 99 Standard Test Method for The Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
D 6124: 00 Standard Test Method for Residual Powder on Medical Gloves
D 6319: 00 Standard Specification for Nitrile Examination Gloves for Medical Application
E 145 : 94 Standard Specification for  Gravity-Convection and Forced-Ventilation Ovens
E 1104: 86 Clinical thermometer probe covers and sheaths
E 1104: 98 Clinical thermometer probe covers and sheaths
E 1112: 86 Electronic thermometer for intermittent Determination of patient temperature
E 1965: 98 Infrared Thermometers for intermittent determination of Patient Temperature
F 67: 95 Standard Specification for Unalloyed Titanium for Surgical Implant Applications 
F 920: 93 Minimum performance and safety requirement for Resuscitators intended for use with humans
F 1054- 01 Standard Specification for Conical Fittings
F 2100- 04 Standard Specification for Performance of materials used in medical Face Masks
F 2224- 03 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
NS 4:1985 American National Standard for Transcutaneous Electrical Nerve Stimulators
SP 9: 1994 Electronic or automated sphygmomanometers
SP 10: 1992 Electronic or automated sphygmomanometers 
SP 10: 2002 Electronic or automated sphygmomanometers 
UL 544 Medical and Dental equipment
UL 1647 Motor-Operated Massage and Exercise Machines
UL 2601-1 Medical Electrical Equipment Part 1: general Requirements for safety

註:1.若您有其它標準之需求, 本會亦將儘速取得. 

        2.本學會擁有申請FDA所需各類的導引( guidance ), 數量眾多, 並未逐一登錄.

 

 

bullet電話            886-3-5208829
bulletSkype         ceirs.jen
bulletQQ           2260905240
bullet傳真           886-3-5209783
bullet郵寄地址   新竹市東香里富群街58號
bullet電子郵件   ceirs.jen@msa.hinet.net

 將您的寶貴意見或問題寄到我們的信箱,我們會儘快處理!!                               
上次修改日期: 2013年03月13日