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{"sheet":"第一組","index":0,"n_rows":20,"n_cols":8,"rows_kept":20,"cut":false,"hidden":false,"merged":[[0,1,0,3]],"flags":["formulas_cached_only"]}
[null,"醫療器材標準採認資料-第一組"]
[null,"項目","類別","標準名稱","標準編號","標準組織","審查結果","審查意見"]
["DOH-00038",1,"ABC.體外診斷醫療器材","Stability Testing of In Vitro Diagnostic Reagents","EN 13640:2002","CEN ","通過","無"]
["DOH-00039",2,"ABC.體外診斷醫療器材","How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline - Second Edition","NCCLS C28-A2:2000","NCCLS ","通過","無"]
["DOH-00040",3,"ABC.體外診斷醫療器材","Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline","NCCLS EP10-A2:2002","NCCLS ","通過","無"]
["DOH-00041",4,"ABC.體外診斷醫療器材","User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline","NCCLS EP12-A:2002","NCCLS ","通過","無"]
["DOH-00042",5,"ABC.體外診斷醫療器材","Evaluation of Matrix Effects; Approved Guideline","NCCLS EP14-A:2001","NCCLS ","通過","無"]
["DOH-00043",6,"ABC.體外診斷醫療器材","User Demonstration of Performance for Precision and Accuracy; Approved Guideline","NCCLS EP15-A:2001","NCCLS ","通過","無"]
["DOH-00044",7,"ABC.體外診斷醫療器材","Quality Management for Unit-Use Testing; Approved Guideline","NCCLS EP18-A:2002","NCCLS ","通過","無"]
["DOH-00045",8,"ABC.體外診斷醫療器材","Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline","NCCLS EP5-A:1999","NCCLS ","通過","無"]
["DOH-00046",9,"ABC.體外診斷醫療器材","Interference Testing in Clinical Chemistry; Approved Guideline","NCCLS EP 7-A:2002","NCCLS ","通過","無"]
["DOH-00047",10,"ABC.體外診斷醫療器材","Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline","NCCLS EP9-A2:2002","NCCLS ","通過","無"]
["DOH-00048",11,"ABC.體外診斷醫療器材","Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline","NCCLS GP 10-A:1995","NCCLS ","通過","無"]
["DOH-00049",12,"ABC.體外診斷醫療器材","Labeling of Home-Use In Vitro Testing Products; Approved Guideline","NCCLS GP14-A:1996","NCCLS ","通過","無"]
["DOH-00050",13,"ABC.體外診斷醫療器材","Urinalysis and Collection, Transportation, and Preservation of Urine Specimens - Second Edition; Approved Guideline","NCCLS GP16-A2:2001","NCCLS ","通過","無"]
["DOH-00051",14,"ABC.體外診斷醫療器材","Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition","NCCLS GP19-A2:2001","NCCLS ","通過","無"]
["DOH-00052",15,"ABC.體外診斷醫療器材","Fine-Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline (1996)","NCCLS GP20-A:1996","NCCLS ","通過","無"]
["DOH-00053",16,"ABC.體外診斷醫療器材","Continuous Quality Improvement: Essential Management Approaches; Approved Guideline","NCCLS GP 22-A:1999","NCCLS ","通過","無"]
["DOH-00054",17,"ABC.體外診斷醫療器材","Using Proficiency Testing (PT) to Improve the Clinical Laboratory; Approved Guideline","NCCLS GP 27-A:1999","NCCLS ","通過","無"]
["DOH-00055",18,"ABC.體外診斷醫療器材","Terminology and Definitions for use in NCCLS Documents; Approved Standard","NCCLS NRSCL 8-A:1998","NCCLS ","通過","無"]

{"sheet":"第二組","index":1,"n_rows":24,"n_cols":8,"rows_kept":24,"cut":false,"hidden":false,"merged":[[0,1,0,3]],"flags":["formulas_cached_only"]}
[null,"醫療器材標準採認資料-第二組"]
[null,"項目","類別","標準名稱","標準編號","標準組織","審查結果","審查意見"]
["DOH-00016",1,"2.生物相容性"," Biological evaluation of medical devices -- Part 2: Animal welfare requirements","ISO 10993-2:1992 ","ISO","通過","尚有ISO 10993-8, 18，宜納入採認，保持完整，以利廠商應用遵循"]
["DOH-00017",2,"2.生物相容性"," Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity","ISO 10993-3:2003 ","ISO","通過","無"]
["DOH-00018",3,"2.生物相容性"," Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood","ISO 10993-4:2002 ","ISO","通過","無"]
["DOH-00019",4,"2.生物相容性"," Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products","ISO 10993-9:1999 ","ISO","通過","無"]
["DOH-00020",5,"2.生物相容性"," Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric","ISO 10993-13:1998 ","ISO","通過","無"]
["DOH-00021",6,"2.生物相容性"," Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics","ISO 10993-14:2001 ","ISO","通過","無"]
["DOH-00022",7,"2.生物相容性"," Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals an","ISO 10993-15:2000 ","ISO","通過","無"]
["DOH-00023",8,"2.生物相容性"," Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables","ISO 10993-16:1997 ","ISO","通過","無"]
["DOH-00024",9,"2.生物相容性"," Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances","ISO 10993-17:2002 ","ISO","通過","無"]
["DOH-00025",10,"3.滅菌","Packaging for terminally sterilized medical devices","ISO 11607:2000"," ISO ","通過","無"]
["DOH-00026",11,"3.滅菌","Sterilization of medical devices-microbiological methods-Part 1: Estimation of the population of microorganisms on product.","ISO 11737-1:1995"," ISO ","通過","無"]
["DOH-00027",12,"3.滅菌","Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process","ISO 11737-2:1998","ISO ","通過","無"]
["DOH-00028",13,"3.滅菌","Aseptic processing of health care products -- Part 1: General requirements","ISO 13408-1:1998","ISO","通過","無"]
["DOH-00029",14,"3.滅菌","Aseptic Processing of Health Care Products - Part 2: Filtration","ISO 13408-2:2003","ISO ","通過","無"]
["DOH-00030",15,"3.滅菌","Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants","ISO 14160:1998","ISO ","通過","無"]
["DOH-00031",16,"3.滅菌","Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results, 2ed.","ISO 14161:2000","ISO ","通過","無"]
["DOH-00032",17,"3.滅菌","Cleanrooms and Associated Conrtolled Environments - Part 1: Classification of Air Cleanliness","ISO 14644-1:1999","ISO ","通過","無"]
["DOH-00033",18,"3.滅菌","Cleanrooms and Associated Controlled Environments - Part 2: Specification for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1","ISO 14644-2:2000","ISO ","通過","無"]
["DOH-00034",19,"3.滅菌","Cleanrooms and Associated Controlled Environments - Part 4: Design, Construction and Start-up","ISO 14644-4:2001","ISO ","通過","無"]
["DOH-00035",20,"3.滅菌","Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods","ISO 14698-1:2003","ISO ","通過","無"]
["DOH-00036",21,"3.滅菌","Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data","ISO 14698-2:2003","ISO ","通過","無"]
["DOH-00037",22,"3.滅菌","Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices","ISO 14937:2000","ISO ","通過","無"]

{"sheet":"第三組","index":2,"n_rows":32,"n_cols":8,"rows_kept":32,"cut":false,"hidden":false,"merged":[[0,1,0,3]],"flags":["formulas_cached_only"]}
[null,"醫療器材標準採認資料-第三組"]
[null,"項目","類別","標準名稱","標準編號","標準組織","審查結果","審查意見"]
["DOH-00056",1,"G.耳鼻喉科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment","IEC  60601-2-18:1996","IEC ","通過","是否有ISO相關標準可納進一起採納，因為IEC 60601主要是著重於醫材電性安全測試"]
["DOH-00057",2,"F.牙科裝置","Dental Handpieces - Dental Air-Motors","ISO  13294:1997","ISO ","通過","無"]
["DOH-00058",3,"F.牙科裝置","Dentistry - Synthetic Polymer Teeth","ISO  3336:1993","ISO ","通過","無"]
["DOH-00059",4,"F.牙科裝置","Dentistry - Polymer-Based Filling, Restorative and Luting Materials","ISO  4049:2000","ISO ","通過","無"]
["DOH-00060",5,"F.牙科裝置","Dental Units","ISO  7494:1996","ISO ","通過","無"]
["DOH-00061",6,"F.牙科裝置","Dentistry - Dental units - Part 2: Water and air supply","ISO  7494-2:2003","ISO ","通過","無"]
["DOH-00062",7,"F.牙科裝置","Part 1: High-Speed Air Turbine Handpieces","ISO  7785-1:1997","ISO ","通過","無"]
["DOH-00063",8,"F.牙科裝置","Part 2: Straight and Geared Angle Handpieces","ISO  7785-2:1995","ISO ","通過","無"]
["DOH-00064",9,"F.牙科裝置","Dental Handpieces - Hose Connectors","ISO  9168:1991","ISO ","通過","無"]
["DOH-00065",10,"5.材料","Implants for surgery -- Metallic materials -- Unalloyed tantalum for surgical implant applications","ISO  13782:1996","ISO ","通過","無"]
["DOH-00066",11,"5.材料","Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel","ISO  5832-1:1997","ISO ","通過","CNS有類似的標準可納入採認"]
["DOH-00067",12,"5.材料","Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium","ISO  5832-2:1999","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00068",13,"5.材料","Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy","ISO  5832-3:1996","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00069",14,"5.材料","Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy","ISO  5832-4:1996","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00070",15,"5.材料","Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy","ISO  5832-5:1993","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00071",16,"5.材料","Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy","ISO  5832-6:1997","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00072",17,"5.材料","Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy ","ISO  5832-7:1994","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00073",18,"5.材料","Implants for surgery -- Metallic materials -- Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy","ISO  5832-8:1997","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00074",19,"5.材料","Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel","ISO  5832-9:1992","ISO ","通過","無"]
["DOH-00075",20,"5.材料","Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy","ISO  5832-11:1994","ISO ","通過","無"]
["DOH-00076",21,"5.材料","Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy","ISO  5832-12:1996","ISO ","通過","我國CNS有相關標準也是Based on ISO，可否一併採納"]
["DOH-00077",22,"5.材料","Implants for surgery -- Ultra-high molecular weight polyethylene -- Part 1: Powder form","ISO  5834-1:1998","ISO ","通過","無"]
["DOH-00078",23,"5.材料","Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms","ISO  5834-2:1998","ISO ","通過","無"]
["DOH-00079",24,"5.材料","Implants for surgery -- Ceramic materials based on high purity alumina","ISO  6474-1994","ISO ","通過","無"]
["DOH-00080",25,"N.骨科用裝置","Non-active surgical implants -- General requirements","ISO  14630:1997","ISO ","通過","無"]
["DOH-00081",26,"N.骨科用裝置","Implants for surgery -- Skeletal pins and wires -- Part 1: Material and mechanical requirements","ISO  5838-1:1995","ISO ","通過","CNS有類似的標準可納入採認"]
["DOH-00082",27,"N.骨科用裝置","Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions","ISO  5838-2:1991","ISO ","通過","CNS有類似的標準可納入採認"]
["DOH-00083",28,"N.骨科用裝置","Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires","ISO  5838-3:1993","ISO ","通過","CNS有類似的標準可納入採認"]
["DOH-00084",29,"N.骨科用裝置","Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions","ISO  7207-1:1994","ISO ","通過","CNS有類似的標準可納入採認"]
["DOH-00085",30,"N.骨科用裝置","Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials","ISO  7207-2:1998","ISO ","通過","CNS有類似的標準可納入採認"]

{"sheet":"第四組","index":3,"n_rows":32,"n_cols":8,"rows_kept":32,"cut":false,"hidden":false,"merged":[[0,1,0,3]],"flags":["formulas_cached_only"]}
[null,"醫療器材標準採認資料-第四組"]
[null,"項目","類別","標準名稱","標準編號","標準組織","審查結果","審查意見"]
["DOH-00086",1,"1.通用","Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidelines - General Requirements and Guidelines for Alarm Systems in Medical Equipment","IEC  60601-1-8:2003","IEC ","通過","無"]
["DOH-00087",2,"1.通用","Analysis technique for system reliability - Procedure for failure modes and effects analysis (FMEA)","IEC  60812:1985","IEC ","通過","無"]
["DOH-00088",3,"1.通用","Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment","ISO  10012:2003","ISO ","通過","無"]
["DOH-00089",4,"1.通用","Medical devices - Application of risk management to medical devices","ISO  14971:2000","ISO ","通過","無"]
["DOH-00090",5,"4.軟體","Information Technology - Software Life Cycle Processes","ISO/IEC 12207:1995","IEC ISO ","通過","無"]
["DOH-00091",6,"4.軟體","Standard for Software Verification and Validation","IEEE  1012:1998","IEEE ","通過","無"]
["DOH-00092",7,"4.軟體","Standard for Developing Software Life Cycle Processes","IEEE  1074:1997","IEEE ","通過","無"]
["DOH-00093",8,"D.麻醉學用裝置","Medical Electrical Equipment Part 3-1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment","IEC 60601-3-1:1996","IEC ","通過","無"]
["DOH-00094",9,"D.麻醉學用裝置","Anaesthetic vaporizers - Agent specific filling systems","ISO  5360:1993","ISO ","通過","無"]
["DOH-00095",10,"D.麻醉學用裝置","Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors","ISO  5361:1999","ISO ","通過","無"]
["DOH-00096",11,"D.麻醉學用裝置","Tracheal Tubes - Part 4: Cole Type","ISO  5361-4:1987","ISO ","通過","無"]
["DOH-00097",12,"D.麻醉學用裝置","Anaesthetic Reservoir Bags","ISO  5362:2000","ISO ","通過","無"]
["DOH-00098",13,"D.麻醉學用裝置","Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults","ISO  5366-1:2000","ISO ","通過","無"]
["DOH-00099",14,"D.麻醉學用裝置","Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes -- Part 3: Pediatric Tracheostomy Tubes","ISO  5366-3:2001","ISO ","通過","無"]
["DOH-00100",15,"D.麻醉學用裝置","Breathing Tubes intended for use with Anaesthetic Apparatus and Ventilators","ISO  5367:2000","ISO ","通過","無"]
["DOH-00101",16,"D.麻醉學用裝置","Oxygen Monitors for Monitoring Patient Breathing Mixtures - Safety Requirements ","ISO  7767:1997","ISO ","通過","無"]
["DOH-00102",17,"D.麻醉學用裝置","Oxygen Concentrators for Medical Use - Safety Requirements","ISO  8359:1996","ISO ","通過","無"]
["DOH-00103",18,"D.麻醉學用裝置","Resuscitators Intended for Use with Humans","ISO  8382:1988","ISO ","通過","無"]
["DOH-00104",19,"D.麻醉學用裝置","Capnometers for Use with Humans - Requirements ","ISO  9918:1993","ISO ","通過","無"]
["DOH-00105",20,"P.放射學科用裝置","Radiotherapy Equipment - Coordinates, movements, and scales","ISO  61217:2003","IEC ","通過","無"]
["DOH-00106",21,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeV","IEC 60601-2-1:1998, A1:2002","IEC ","通過","無"]
["DOH-00107",22,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range 10 kV to 1 MV","IEC  60601-2-8:1999","IEC ","通過","無"]
["DOH-00108",23,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment ","IEC  60601-2-11:1997","IEC ","通過","無"]
["DOH-00109",24,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis","IEC  60601-2-28:1993","IEC ","通過","無"]
["DOH-00110",25,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Radiotherapy Simulators","IEC  60601-2-29:1999","IEC ","通過","無"]
["DOH-00111",26,"P.放射學科用裝置","Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (1994)","IEC  60601-2-32:1994","IEC ","通過","無"]
["DOH-00112",27,"P.放射學科用裝置","Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis","IEC  60601-2-33:2002","IEC ","通過","無"]
["DOH-00113",28,"P.放射學科用裝置","Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment","IEC  60601-2-37:2001","IEC ","通過","無"]
["DOH-00114",29,"P.放射學科用裝置","Medical electrical equipment - Part 2-43: Particular requirements for the safety of x-ray equipment for interventional procedures","IEC  60601-2-43 :2000","IEC ","通過","無"]
["DOH-00115",30,"P.放射學科用裝置","Particular requirements for the safety of X-ray equipment for computed tomography","IEC  60601-2-44 :2002","IEC ","通過","無"]

{"sheet":"第五組","index":4,"n_rows":54,"n_cols":8,"rows_kept":54,"cut":false,"hidden":false,"merged":[[0,1,0,3]],"flags":["formulas_cached_only"]}
[null,"醫療器材標準採認資料-第五組"]
[null,"項目","類別","標準名稱","標準編號","標準組織","審查結果","審查意見"]
["DOH-00116",1,"K.神經學科用裝置","Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators","IEC 60601-2-10 :1987","IEC ","通過","無"]
["DOH-00117",2,"J.一般醫院及個人使用裝置","Sterile - Single-use Intravascular catheters Part 1: General requirements","ISO  10555-1:1995, A1: 1999","ISO ","通過","無"]
["DOH-00118",3,"J.一般醫院及個人使用裝置","Sterile Single-Use Intravascular Catheters part 3: Central Venous Catheter","ISO 10555-3:1996, Cor1:2002","ISO ","通過","無"]
["DOH-00119",4,"J.一般醫院及個人使用裝置","Sterile, Single-use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters, Amendment 1 1999-06-15","ISO 10555-5:1996, A1:1999","ISO ","通過","無"]
["DOH-00120",5,"J.一般醫院及個人使用裝置","Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use","ISO 7886-1:1993","ISO ","通過","無"]
["DOH-00121",6,"J.一般醫院及個人使用裝置","Sterile Hypodermic Syringes for Single Use - Part 2: Syringes for use with Power-Driven Syringe Pumps","ISO 7886-2:1996","ISO ","通過","無"]
["DOH-00122",7,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 1: Infusion Glass Bottles","ISO 8536-1:2000, A1:2004","ISO ","通過","無"]
["DOH-00123",8,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 2: Closures for Infusion Bottles","ISO 8536-2:2001, Cor 1:2003","ISO ","通過","無"]
["DOH-00124",9,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 3: Aluminum Caps for Infusion Bottles","ISO 8536-3:1999","ISO ","通過","無"]
["DOH-00125",10,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use, Gravity Feed","ISO 8536-4:2004","ISO ","通過","無"]
["DOH-00126",11,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 5: Burette Type Infusion Sets","ISO 8536-5:2004","ISO ","通過","無"]
["DOH-00127",12,"J.一般醫院及個人使用裝置","Infusion Equipment for Medical Use - Part 6: Freeze Drying Closures for Infusion Bottles","ISO 8536-6:1995","ISO ","通過","無"]
["DOH-00128",13,"J.一般醫院及個人使用裝置","Infusion Equipment, Caps made of Aluminum-Plastic Combinations for Infusion Bottles","ISO 8536-7:1999","ISO ","通過","無"]
["DOH-00129",14,"L.婦產科用裝置","Natural latex rubber condoms - Requirements and test methods","ISO  4074:2002","ISO ","通過","無"]
["DOH-00130",15,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of curvature","ISO 10338:1996","ISO ","通過","無"]
["DOH-00131",16,"M.眼科用裝置","Ophthalmic optics -- Contact lenses -- Determination of water content of hydrogel lenses","ISO 10339:1997","ISO ","通過","無"]
["DOH-00132",17,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Method for determining the extractable substances","ISO 10340:1995","ISO ","通過","無"]
["DOH-00133",18,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Saline solution for contact lens testing","ISO 10344:1996","ISO ","通過","無"]
["DOH-00134",19,"M.眼科用裝置","Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of physical compatibility of contact lens care products with contact lenses","ISO  11981:1999","ISO ","通過","無"]
["DOH-00135",20,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Part 1: Determination of oxygen permeability and transmissibility with the FATT method","ISO  9913-1:1996","ISO ","通過","無"]
["DOH-00136",21,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Part 2: Determination of oxygen permeability and transmissibility by the coulometric method","ISO  9913-2:2000","ISO ","通過","無"]
["DOH-00137",22,"M.眼科用裝置","Ophthalmic optics -- Specifications for material, optical and dimensional properties of contact lenses -- Part 1: Rigid corneal and scleral contact lenses","ISO  8321-1:2002","ISO","通過","無"]
["DOH-00138",23,"M.眼科用裝置","Ophthalmic optics -- Specifications for material, optical and dimensional properties of contact lenses -- Part 2: Single-vision hydrogel contact lenses","ISO 8321-2:2000","ISO","通過","無"]
["DOH-00139",24,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of the spectral and luminous transmittance ","ISO 8599:1994","ISO","通過","無"]
["DOH-00140",25,"M.眼科用裝置","Contact lenses -- Determination of back vertex power -- Part 1: Method using focimeter with manual focusing ","ISO 9337-1:1999","ISO","通過","無"]
["DOH-00141",26,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of the diameters ","ISO 9338:1996","ISO","通過","無"]
["DOH-00142",27,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of the thickness -- Part 1: Rigid contact lenses ","ISO 9339-1:1996","ISO","通過","無"]
["DOH-00143",28,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of thickness -- Part 2: Hydrogel contact lenses ","ISO 9339-2:1998","ISO","通過","無"]
["DOH-00144",29,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of strains for rigid contact lenses","ISO 9340:1996","ISO","通過","無"]
["DOH-00145",30,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of inclusions and surface imperfections for rigid contact lenses ","ISO 9341:1996","ISO","通過","無"]
["DOH-00146",31,"M.眼科用裝置","Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of biocompatibility by ocular study using rabbit eyes ","ISO 9394:1998 ","ISO","通過","無"]
["DOH-00147",32,"M.眼科用裝置","Optics and optical instruments -- Contact lenses -- Determination of refractive index of contact lens materials ","ISO 9914:1995","ISO","通過","無"]
["DOH-00148",33,"M.眼科用裝置","Ophtalmic optics -- Contact lenses -- Determination of shelf-life ","ISO 11987:1997","ISO","通過","無"]
["DOH-00149",34,"M.眼科用裝置","Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements ","ISO 14534:2002","ISO","通過","無"]
["DOH-00150",35,"M.眼科用裝置","Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date ","ISO 14730:2000 ","ISO","通過","無"]
["DOH-00151",36,"O.物理醫學科用裝置","Wheelchairs - Part 1: Determination of Static Stability","ISO 7176-1:1999","ISO ","通過","無"]
["DOH-00152",37,"O.物理醫學科用裝置","Wheelchairs - Part 2: Determination of Dynamic Stability of Electric Wheelchairs","ISO 7176-2:2001","ISO ","通過","無"]
["DOH-00153",38,"O.物理醫學科用裝置","Wheelchairs - Part 3: Determination of Effectiveness of Brakes","ISO 7176-3:2003","ISO ","通過","無"]
["DOH-00154",39,"O.物理醫學科用裝置","Wheelchairs - Part 4: Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range","ISO 7176-4:1997","ISO ","通過","無"]
["DOH-00155",40,"O.物理醫學科用裝置","Wheelchairs - Part 5: Determination of Overall Dimensions, Mass and Turning Space","ISO 7176-5:1986","ISO ","通過","無"]
["DOH-00156",41,"O.物理醫學科用裝置","Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs","ISO 7176-6:2001","ISO ","通過","無"]
["DOH-00157",42,"O.物理醫學科用裝置","Wheelchairs -- Part 7: Measurement of seating and wheel dimensions ","ISO 7176-7:1998 ","ISO ","通過","無"]
["DOH-00158",43,"O.物理醫學科用裝置","Wheelchairs -- Part 8: Requirements and test methods for static, impact and fatigue strengths ","ISO 7176-8:1998 ","ISO ","通過","無"]
["DOH-00159",44,"O.物理醫學科用裝置","Wheelchairs - Part 9: Climatic tests for electric wheelchairs","ISO 7176-9:2001","ISO ","通過","無"]
["DOH-00160",45,"O.物理醫學科用裝置","Wheelchairs - Part 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs","ISO 7176-10:1988","ISO ","通過","無"]
["DOH-00161",46,"O.物理醫學科用裝置","Wheelchairs - Part 11: Test Dummies","ISO 7176-11:1992","ISO ","通過","無"]
["DOH-00162",47,"O.物理醫學科用裝置","Wheelchairs - Part 13: Determination of Coefficient of Friction of Test Surfaces","ISO 7176-13:1989","ISO ","通過","無"]
["DOH-00163",48,"O.物理醫學科用裝置","Wheelchairs - Part 14: Power and Control Systems for Electric Wheelchairs - Requirements and Test Methods","ISO 7176-14:1997","ISO ","通過","無"]
["DOH-00164",49,"O.物理醫學科用裝置","Wheelchairs - Part 15: Requirements for Information Disclosure, Documentation and Labelling","ISO 7176-15:1996","ISO ","通過","無"]
["DOH-00165",50,"O.物理醫學科用裝置","Wheelchairs - Part 16: Resistance to Ignition of Upholstered Parts -- Requirements and Test Methods","ISO 7176-16: 1997","ISO ","通過","無"]
["DOH-00166",51,"O.物理醫學科用裝置","Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters ","ISO 7176-21:2003 ","ISO ","通過","鄭國順-本標準納入醫療器材認定資料庫可以加速國內標準與世界同步更新之目的。其中涉及其他相關標準，應查考國內沒有之標準加以相互對照"]
["DOH-00167",52,"O.物理醫學科用裝置","Wheelchairs -- Part 22: Set-up procedures","ISO 7176-22:2000 ","ISO ","通過","無"]