{"text_format":"3","workbook":"xls","n_sheets":5,"sheets":["第一組","第二組","第三組","第四組","第五組"],"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"第一組","index":0,"n_rows":30,"n_cols":5,"rows_kept":30,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料-第一組                    審查委員：戚偉明理事長"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-00318",1,"InVitro","Information supplied by the manufacturer with in vitro diagnostic reagents for professional use","EN 375:2001"]
["DOH-00319",2,"InVitro","Performance evaluation of in vitro diagnostic medical devices","EN 13612:2002"]
["DOH-00320",3,"InVitro","In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ","EN ISO 17511:2003"]
["DOH-00321",4,"InVitro","In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials","EN ISO 18153:2003"]
["DOH-00322",5,"InVitro","Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine","CLSI MM9-A"]
["DOH-00323",6,"InVitro","Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline - Fourth Edition","CLSI H21-A4"]
["DOH-00324",7,"InVitro","Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guidelines","CLSI I/LA23-A"]
["DOH-00325",8,"InVitro","Clinical laboratory testing and in vitro diagnostic test systems─In vitro diagnostic medical devices for professional use─Summary of regulatory requirements for information supplied by the manufacturer","ISO/TR18112"]
["DOH-00326",9,"InVitro","Preparation and Testing of Reagent Water in the Clinical Laboratory"," CLSI C3-A4"]
["DOH-00327",10,"InVitro","Analysis of body fluids in clinical laboratory","CLSI C49-P"]
["DOH-00328",11,"InVitro","Body fluid analysis for cellular composition","CLSI H56-A"]
["DOH-00329",12,"InVitro","Quality assurance of laboratory tests for autoantibodies to nuclear antigens: (1)Indirect fluorescence assay for microscopy and (2) Microtiter enzyme immunoassay methods","CLSI I/LA2-A2"]
["DOH-00330",13,"InVitro","Genotyping for infectious diseases: Identification and characterization","CLSI MM10-P"]
["DOH-00331",14,"InVitro","Molecular methods for bacterial strain typing","CLSI MM11-P"]
["DOH-00332",15,"InVitro","Diagnostic nucleic acid microarrays","CLSI MM12-A"]
["DOH-00333",16,"InVitro","Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline","CLSI C38-A"]
["DOH-00334",17,"InVitro","A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard  ","CLSI C39-A"]
["DOH-00335",18,"InVitro","Gas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Approved Guideline","CLSI C43-A"]
["DOH-00336",19,"InVitro","Harmonization of Glycohemoglobin Measurements; Approved Guideline","CLSI C44-A"]
["DOH-00337",20,"InVitro","Measurement of Free Thyroid Hormones; - Approved Guideline","CLSI C45-A"]
["DOH-00338",21,"InVitro","Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard","CLSI H17-A"]
["DOH-00339",22,"InVitro","Performance of the Bleeding Time Test; Approved Guideline","CLSI H45-A2"]
["DOH-00340",23,"InVitro","Quality Assurance for Immunocytochemistry; Approved Guideline","CLSI MM4-A"]
["DOH-00341",24,"InVitro","Quantitative Molecular Methods for Infectious Diseases; Proposed Guideline","CLSI MM6-A"]
["DOH-00342",25,"InVitro","Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline","CLSI MM14-A"]
["DOH-00343",26,"InVitro","Point-of-Care Connectivity; Approved Standard","CLSI POCT1-A"]
["DOH-00344",27,"InVitro","Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard","CLSI AUTO3-A"]
["DOH-00345",28,"InVitro","Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard","CLSI AUTO4-A"]

{"sheet":"第二組","index":1,"n_rows":29,"n_cols":5,"rows_kept":29,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料-第二組                    審查委員：張炎林副教授"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-00346",1,"Biocompatibility","Biological evaluation of medical devices —Part 18:\nChemical characterization of materials","ISO 10993-18:2005"]
["DOH-00347",2,"Biocompatibility","Biological evaluation of medical devices —Part 19:\nPhysico-chemical, morphological and topographical characterization of materials ","ISO/TS 10993-19:2006"]
["DOH-00348",3,"Biocompatibility","Biological evaluation of medical devices —Part 20:\n Principles and methods for immunotoxicology testing of medical devices\n ","ISO/TS 10993-20:2006"]
["DOH-00349",4,"Sterilization","Packaging for terminally sterilized medical devices —Part 1: Requirements for materials, sterile barrier systems and packaging systems","ISO11607-1:2006"]
["DOH-00350",5,"Sterilization","Packaging for terminally sterilized medical devices —Part 2:\nValidation requirements for forming, sealing and assembly processes","ISO11607-2:2006"]
["DOH-00351",6,"Sterilization","Aseptic processing of health care products —Part 4: Clean-in-place technologies","ISO13408-4:2005"]
["DOH-00352",7,"Sterilization","Aseptic processing of health care products -- Part 6: Isolator systems","ISO13408-6:2005"]
["DOH-00353",8,"Sterilization","Cleanrooms and associated controlled environments —\nPart 3: Test methods","ISO14644-3:2005"]
["DOH-00354",9,"Sterilization","Cleanrooms and associated controlled environments —\nPart 5: Operations","ISO14644-5:2004"]
["DOH-00355",10,"Sterilization","Cleanrooms and associated controlled environments —\nPart 7: Separative devices (clean air hoods,\ngloveboxes, isolators and minienvironments)","ISO14644-7:2004"]
["DOH-00356",11,"Sterilization","Sterilization of health care products —Radiation —\nPart 1: Requirements for development, validation\nand routine control of a sterilization process for medical devices","ISO11137-1:2006"]
["DOH-00357",12,"Sterilization","Sterilization of health care products —Radiation —\nPart 2: Establishing the sterilization dose","ISO11137-2:2006"]
["DOH-00358",13,"Sterilization","Sterilization of health care products —Radiation —\nPart 3: Guidance on dosimetric aspects","ISO11137-3:2006"]
["DOH-00359",14,"Sterilization","Sterilization of health care products —Biological and chemical indicators —Test equipment","ISO18472:2006"]
["DOH-00360",15,"Sterilization","Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices","EN 556-1:2001"]
["DOH-00361",16,"Biocompatibility","Biological evaluation of medical devices -- Part 2: Animal welfare requirements","ISO 10993-2:2006"]
["DOH-00362",17,"Biocompatibility","Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity ","ISO 10993-10:2002/ Amd 1:2006"]
["DOH-00363",18,"Biocompatibility","醫療器材生物性評估-第一部份：評估與試驗","CNS14393-1"]
["DOH-00364",19,"Biocompatibility","醫療器材生物性評估-第二部份：動物福利之規定","CNS14393-2"]
["DOH-00365",20,"Biocompatibility","醫療器材生物性評估-第三部份：基因毒性、致癌性與生殖毒性之試驗","CNS14393-3"]
["DOH-00366",21,"Biocompatibility","醫療器材生物性評估-第四部份：血液接觸特性測試方法的選擇","CNS14393-4"]
["DOH-00367",22,"Biocompatibility","醫療器材生物性評估-第五部份：體外細胞毒性試驗","CNS14393-5"]
["DOH-00368",23,"Biocompatibility","醫療器材生物性評估-第九部份：潛在降解產物之鑑別與定量分析架構","CNS14393-9"]
["DOH-00369",24,"Biocompatibility","醫療器材生物性評估-第十三部份：聚合物醫療器材降解產物之鑑別與定量","CNS14393-13"]
["DOH-00370",25,"Biocompatibility","醫療器材生物性評估-第十四部份：陶瓷降解產物之鑑別與定量","CNS14393-14"]
["DOH-00371",26,"Biocompatibility","醫療器材生物性評估-第十五部份：金屬集合金之降解產物的鑑別與定量","CNS14393-15"]
["DOH-00372",27,"Biocompatibility","醫療器材生物性評估-第十六部份：降解及可溶出物之毒性動力學之研究設計","CNS14393-16"]

{"sheet":"第三組","index":2,"n_rows":34,"n_cols":5,"rows_kept":34,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料-第三組                    審查委員：林峰輝教授"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-00373",1,"Dental","Resin-Based Filling Materials","ADA Specification No.27:1997"]
["DOH-00374",2,"Dental","Dental-Water-Based Cements - Adoption of ISO 9917:1991","ADA Specification No.96"]
["DOH-00375",3,"Dental","Dentistry - Medical devices for dentistry - Instruments","EN 1639:1996"]
["DOH-00376",4,"Dental","Dentistry - Medical devices for dentistry - Equipment","EN 1640:1996"]
["DOH-00377",5,"Dental","Dentistry - Medical devices for dentistry - Materials","EN 1641:1996"]
["DOH-00378",6,"Dental","Dentistry - Medical devices for dentistry - Dental implants","EN 1642:1996"]
["DOH-00379",7,"Dental","Dentistry -- Number coding system for rotary instruments -- Part 1: General characteristics","ISO 6360-1: 2004"]
["DOH-00380",8,"Dental","Dentistry -- Number coding system for rotary instruments -- Part 2: Shapes","ISO 6360-2: 2004"]
["DOH-00381",9,"Dental","Dentistry -- Number coding system for rotary instruments -- Part 3: Specific characteristics of burs and cutters","ISO 6360-3: 2005"]
["DOH-00382",10,"Dental","Dentistry -- Number coding system for rotary instruments -- Part 4: Specific characteristics of diamond instruments","ISO 6360-4: 2004"]
["DOH-00383",11,"Dental","Dentistry -- Number coding system for rotary instruments -- Part 6: Specific characteristics of abrasive instruments","ISO 6360-6: 2004"]
["DOH-00384",12,"Dental","Dentistry – Number coding system for rotary instruments – Part 7: Specific characteristics of mandrels and special instruments","ISO 6360-7: 2006 "]
["DOH-00385",13,"Dental","Periodontal curettes, dental scalers and excavators -- Part 1: General requirements","ISO 13397-1: 1995"]
["DOH-00386",14,"Dental","Dentistry – Periodontal curettes, dental scalers and excavators – Part 2: Periodontal curettes of Gr-type","ISO 13397-2: 2005"]
["DOH-00387",15,"Dental","Periodontal curettes, dental scalers and excavators -- Part 3: Dental scalers -- H-type","ISO 13397-3: 1996"]
["DOH-00388",16,"Dental","Periodontal curettes, dental scalers and excavators -- Part 4: Dental excavators -- Discoid-type","ISO 13397-4: 1997"]
["DOH-00389",17,"Dental","Dentistry – Casting and baseplate waxes","ISO 15854:2005"]
["DOH-00390",18,"ENT","Specification for Audiometers","ASA S3.6-2004"]
["DOH-00391",19,"ENT","Specification of Hearing Aid Characteristics","ASA S3.22:2003"]
["DOH-00392",20,"Dental","Dentistry -- Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials","ISO 7405:1997"]
["DOH-00393",21,"Dental","Dentistry -- Zinc oxide/eugenol and zinc oxide/non-eugenol cements","ISO 3107:2004"]
["DOH-00394",22,"Mat","Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy","ISO 5832-5:2005"]
["DOH-00395",23,"Mat"," Implants for surgery – Ultra-high molecular-weight polyethylene – Part 2: Moulded forms","ISO 5834-2: 2006"]
["DOH-00396",24,"Mat"," Implants for surgery – Ultra-high molecular-weight polyethylene – Part 3: Accelerated ageing methods","ISO 5834-3: 2005"]
["DOH-00397",25,"Mat","Implants for surgery – Ultra-high molecular-weight polyethylene – Part 4: Oxidation index measurement method","ISO 5834-4: 2005 "]
["DOH-00398",26,"Mat","Implants for surgery – Ultra-high molecular-weight polyethylene – Part 5: Morphology assessment method","ISO 5834-5: 2005 "]
["DOH-00399",27,"Mat","Implants for surgery – Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices"," ISO 16428:2005 "]
["DOH-00400",28,"Ortho","Implants for surgery -- Wear of total knee-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test","ISO 14243-1: 2002"]
["DOH-00401",29,"Ortho","Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of measurement","ISO 14243-2: 2000"]
["DOH-00402",30,"Ortho"," Implants for surgery – Wear of total knee joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test – Technical Corrigendum 1","ISO 14243-3: 2004/Cor 1: 2006 "]
["DOH-00403",31,"Ortho","Non-active surgical implants — Implants for Osteosynthesis — Particular requirements","ISO 14602:1998 "]
["DOH-00404",32,"Ortho","Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants","ISO 21535:2002  "]

{"sheet":"第四組","index":3,"n_rows":43,"n_cols":5,"rows_kept":43,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料-第四組                    審查委員：高材教授"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-00405",1,"Anesthesia","Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices","ISO 10524-1: 2006 "]
["DOH-00406",2,"Anesthesia","Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators","ISO 10524-2: 2005 "]
["DOH-00407",3,"Anesthesia"," Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylinder valves","ISO 10524-3: 2005 "]
["DOH-00408",4,"Anesthesia","Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators","ISO 10651-3: 1997"]
["DOH-00409",5,"Anesthesia","Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators","ISO 10651-4: 2002"]
["DOH-00410",6,"Anesthesia","Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas powered emergency resuscitators","ISO 10651-5: 2006"]
["DOH-00411",7,"Anesthesia","Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors-Technical Corrigendum 1","ISO 21647: 2004/Cor 1:2005"]
["DOH-00412",8,"Radiology","Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0","IEC 61847: 1998"]
["DOH-00413",9,"Radiology","Ultrasonics - Physiotherapy systems - Performance requirements and methods of measurement in the frequency range 0.5 MHz to 5 MHz Ed. 1.0","IEC61689:1996"]
["DOH-00414",10,"Radiology","Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams","ISO 11146-2:2005"]
["DOH-00415",11,"Radiology","Lasers and laser-related equipment -- Test methods for laser beam widths, divergence angles and beam propagation ratios -- Part 3: Intrinsic and geometrical laser beam classification, propagation and details of test methods","ISO/TR 11146-3:2004/Cor 1:2005"]
["DOH-00416",12,"Radiology","Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment Ed. 2.0","IEC 60601-2-5:2000:"]
["DOH-00417",13,"Radiology","Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient","ISO 9236-1:2004"]
["DOH-00418",14,"Radiology","Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications","ISO 4090:2001"]
["DOH-00419",15,"Radiology","Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient","ISO 5799:1991"]
["DOH-00420",16,"Radiology","Calibration and Usage of \"Dose Calibrator\" Ionization Chambers for the Assay of Radionuclides","IEEE N42.13-1986"]
["DOH-00421",17,"Radiology","Lasers and laser-related equipment -- Test methods for determination of the shape of a laser beam wavefront -- Part 1: Terminology and fundamental aspects","ISO 15367-1:2003"]
["DOH-00422",18,"Radiology","Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors","ISO 15367-2:2005"]
["DOH-00423",19,"Radiology","Safety of laser products - Part 1: Equipment classification, requirements and user's guide","IEC 60825-1 - Consol. Ed. 1.2 (incl. am1+am2)"]
["DOH-00424",20,"Radiology","Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS)","IEC 60825-2 - Ed. 3.0"]
["DOH-00425",21,"Radiology","Safety of laser products - Part 3: Guidance for laser displays and shows","IEC/TR 60825-3 - Ed. 1.0 "]
["DOH-00426",22,"Radiology","Safety of laser products - Part 4: Laser guards","IEC 60825-4 - Consol. Ed. 1.2 (incl. am1+am2) "]
["DOH-00427",23,"Radiology","Safety of laser products - Part 5: Manufacturer's checklist for IEC 60825-1","IEC/TR 60825-5 - Ed. 2.0 "]
["DOH-00428",24,"Radiology","Safety of laser products - Part 8: Guidelines for the safe use of medical laser equipment","IEC/TR 60825-8 - Ed. 1.0"]
["DOH-00429",25,"Radiology","Safety of laser products - Part 9: Compilation of maximum permissible exposure to incoherent optical radiation","IEC/TR 60825-9 - Ed. 1.0"]
["DOH-00430",26,"Radiology","Safety of laser products - Part 10: Application guidelines and explanatory notes to IEC 60825-1","IEC/TR 60825-10 - Ed. 1.0 "]
["DOH-00431",27,"Radiology","Safety of laser products - Part 14: A user's guide","IEC/TR 60825-14 - Ed. 1.0"]
["DOH-00432",28,"General ","Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices","ISO/TR 16142"]
["DOH-00433",29,"General ","Medical electrical equipment -- Part 1-8: General requirements for safety -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ","IEC 60601-1-8:2003/Amd 1:2006"]
["DOH-00434",30,"General ","Medical electrical equipment - Part 1: General requirements for basic safety and essential performance","IEC 60601-1:2005 "]
["DOH-00435",31,"General ","Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests","IEC 60601-1-2: 2005 Consol. Ed. 2.1 (incl. am1)"]
["DOH-00436",32,"General ","Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)","IEC 60812: 2006 - Ed. 2.0 "]
["DOH-00437",33,"General ","Medical devices -- Application of risk management to medical devices","ISO 14971:2000/ Amd 1:2003"]
["DOH-00438",34,"Software","Medical device software - Software life cycle processes","IEC 62304:2006 - Ed. 1.0"]
["DOH-00439",35,"General ","命名─用於醫療器材法規管理資料交換之命名系統的規格","CNS14991"]
["DOH-00440",36,"General ","醫療器材風險管理","CNS14989"]
["DOH-00441",37,"General ","醫療器材─用於醫療器材標識、標示與資訊之符號","CNS14990"]
["DOH-00442",38,"General ","用於法規目的之醫療器材品質管理系統要求","CNS15013"]
["DOH-00443",39,"Software","Medical device software risk management","AAMI TIR32:2004"]
["DOH-00444",40,"Software","Medical device software—Software life cycle processes","ANSI/AAMI SW68:2001"]
["DOH-00445",41,"Anesthesia"," Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)","EN ISO 18779:2005"]

{"sheet":"第五組","index":4,"n_rows":35,"n_cols":5,"rows_kept":35,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料-第五組                    審查委員：林啟萬教授"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-00446",1,"Card/Neur","Cardiovascular implants - Cardiac valve prostheses","ISO 5840:2005"]
["DOH-00447",2,"Card/Neur"," Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers","ISO 14708-2: 2005 "]
["DOH-00448",3,"Card/Neur","Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses – Amendment 1: Test methods","ISO 25539-1: 2003/Amd 1: 2005"]
["DOH-00449",4,"Card/Neur","Cardiovascular implants and artificial organs – Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)","ISO 15676:2005 "]
["DOH-00450",5,"Card/Neur","Cardiovascular implants — Tubular vascular prostheses","ISO 7198:1998 "]
["DOH-00451",6,"Card/Neur","Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)","ISO 7199:1996"]
["DOH-00452",7,"Card/Neur","Cardiovascular implants and artificial organs-Haemodialysers, haemofilters and haemoconcentrators","ISO 8637:2004"]
["DOH-00453",8,"Card/Neur","Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators","ISO 8638:2004"]
["DOH-00454",9,"Card/Neur","Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags","ISO 15674:2001"]
["DOH-00455",10,"Card/Neur","Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters","ISO 15675:2001 "]
["DOH-00456",11,"Card/Neur"," Cardiovascular implants and artificial organs – Plasmafilters","ISO 13960:2003"]
["DOH-00457",12,"GPS/GH","Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs","ASTM D6978-05"]
["DOH-00458",13,"GPS/GH","Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization","ISO 7886-3:2005"]
["DOH-00459",14,"GPS/GH","Standard Practice for Determination of Expiration Dating for Medical Gloves","ASTM D7160-05"]
["DOH-00460",15,"GPS/GH","Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions","ASTM D7161-05"]
["DOH-00461",16,"Ophth","Ophthalmics - Intraocular Lenses","ANSI Z80.7-2002:"]
["DOH-00462",17,"Ophth","Ophthalmics -- Contact lenses -- Standard Terminology, Tolerances, Measurements and Physicochemical Properties","ANSI Z80.20-2004:"]
["DOH-00463",18,"GPS/GH"," Pen-injectors for medical use – Part 4:Requirements and test methods for electronic and electromechanical pen-injectors","ISO 11608-4:2006"]
["DOH-00464",19,"GPS/GH","Needle-free injectors for medical use –Requirements and test methods"," ISO 21649:2006 "]
["DOH-00465",20,"GPS/GH","Injection containers and accessories -- Part 1: Injection vials made of glass tubing","ISO 8362-1:2003"]
["DOH-00466",21,"GPS/GH","Injection containers for injectables and accessories -- Part 2: Closures for injection vials","ISO 8362-2:1988"]
["DOH-00467",22,"GPS/GH","Injection containers and accessories -- Part 3: Aluminium caps for injection vials","ISO 8362-3:2001"]
["DOH-00468",23,"GPS/GH","Injection containers and accessories -- Part 4: Injection vials made of moulded glass","ISO 8362-4:2003"]
["DOH-00469",24,"GPS/GH","Injection containers for injectables and accessories -- Part 5: Freeze drying closures for injection vials","ISO 8362-5:1995"]
["DOH-00470",25,"GPS/GH","Injection containers for injectables and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials","ISO 8362-6:1992"]
["DOH-00471",26,"GPS/GH"," Injection containers and accessories –Part 7: Injection caps made of aluminiumplastics combinations without overlapping plastics part","ISO 8362-7:2006 "]
["DOH-00472",27,"GPS/GH","Infusion equipment for medical use -- Part 1: Infusion glass bottles","ISO 8536-1:2006"]
["DOH-00473",28,"GPS/GH"," Injection equipment for medical use –Part 1: Ampoules for injectables","ISO 9187-1:2006"]
["DOH-00474",29,"Card/Neur","Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents","EN 14299:2004"]
["DOH-00475",30,"Card/Neur","Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes","EN 12006-1:1999"]
["DOH-00476",31,"Card/Neur","Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits","EN 12006-2:1998"]
["DOH-00477",32,"Card/Neur","Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices","EN 12006-3:1998"]
["DOH-00478",33,"GPS/GH","脫脂紗布","CNS 4397"]