{"text_format":"3","workbook":"xls","n_sheets":5,"sheets":["1","2","3","4","5"],"not_rendered":{"external_links":1,"defined_names":5},"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"1","index":0,"n_rows":35,"n_cols":5,"rows_kept":35,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料：第一組 "]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-000479",1,"IVD","Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment ","CEI/IEC 61326-2-6:2005"]
["DOH-000480",2,"IVD","Point-of-care testing (POCT) -- Requirements for quality and competence","ISO 22870:2006"]
["DOH-000481",3,"IVD","Point-of-Care Connectivity; Approved Standard- Second Edition","POCT1-A2 "]
["DOH-000482",4,"IVD","Implementation Guide of POCT1 for Healthcare Providers; Proposed Guideline","POCT2-P"]
["DOH-000483",5,"IVD","Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline - Second Edition","POCT4-A2 "]
["DOH-000484",6,"IVD","體外診斷系統－糖尿病管理時自我\n檢測用血糖監測系統之規定","CNS 15035:2006"]
["DOH-000485",7,"IVD","Wellness Testing Using IVD Devices; Approved Guideline","AST3-A"]
["DOH-000486",8,"IVD","Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline—Second Edition","AST4-A2"]
["DOH-000487",9,"IVD","Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard","AUTO1-A"]
["DOH-000488",10,"IVD","Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard\u0097Second Edition","AUTO2-A2"]
["DOH-000489",11,"IVD","Laboratory Automation: Electromechanical Interfaces; Approved Standard","AUTO5-A"]
["DOH-000490",12,"IVD","Laboratory Automation: Data Content for Specimen Identification; Approved Standard","AUTO7-A"]
["DOH-000491",13,"IVD","Protocols to Validate Laboratory Information Systems; Proposed Guideline","AUTO8-P"]
["DOH-000492",14,"IVD","Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Proposed Standard","AUTO9-P"]
["DOH-000493",15,"IVD","Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline","C37-A"]
["DOH-000494",16,"IVD","Analytical Procedures for the Determination of Lead in Blood and Urine; Approved Guideline","C40-A"]
["DOH-000495",17,"IVD","Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline","EP6-A"]
["DOH-000496",18,"IVD","Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline","EP17-A"]
["DOH-000497",19,"IVD","Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline","EP21-A"]
["DOH-000498",20,"IVD","Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline ","GP10-A"]
["DOH-000499",21,"IVD","Protocols for Evaluating Dehydrated Mueller–Hinton Agar; Approved Standard","M6-A"]
["DOH-000500",22,"IVD","Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard\u0097Seventh Edition","M7-A7"]
["DOH-000501",23,"IVD","Methodology for the Serum Bactericidal Test; Approved Guideline","M21-A"]
["DOH-000502",24,"IVD","Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition","M22-A3"]
["DOH-000503",25,"IVD","Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Second Edition","M23-A2"]
["DOH-000504",26,"IVD","Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard","M24-A"]
["DOH-000505",27,"IVD","Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline","M26-A"]
["DOH-000506",28,"IVD","Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Informational Supplement","M31-S1"]
["DOH-000507",29,"IVD","Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard—Second Edition","M31-A2"]
["DOH-000508",30,"IVD","Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline","M32-P"]
["DOH-000509",31,"IVD","Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline","M39-P"]
["DOH-000510",32,"IVD","Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Proposed Guideline","M45-P"]
["DOH-000511",33,"IVD","Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline","MM13-A"]

{"sheet":"2","index":1,"n_rows":28,"n_cols":5,"rows_kept":28,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料：第二組"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-000512",1,"Sterilization","Sterilization of health care products -- Chemical indicators -- Part 1: General requirements","ISO 11140-1:2005 "]
["DOH-000513",2,"Biocompatibility","Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity","ISO 10993-3:2003"]
["DOH-000514",3,"Biocompatibility","Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood","ISO 10993-4:2002/Amd 1:2006"]
["DOH-000515",4,"Biocompatibility","Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation","ISO 10993-6:2007"]
["DOH-000516",5,"Biocompatibility","\n Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity ","\n ISO 10993-10:2002/Amd 1:2006 "]
["DOH-000517",6,"Biocompatibility","Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity","ISO 10993-11:2006"]
["DOH-000518",7,"Sterilization","Sterilization of health care products -- Biological indicators -- Part 1: General requirements","ISO 11138-1:2006"]
["DOH-000519",8,"Sterilization","Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes","ISO 11138-2:2006"]
["DOH-000520",9,"Sterilization","Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes","ISO 11138-3:2006"]
["DOH-000521",10,"Sterilization","Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes","\n ISO 11138-4:2006 "]
["DOH-000522",11,"Sterilization","Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes","ISO 11138-5:2006"]
["DOH-000523",12,"Sterilization","Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test","ISO 11140-3:2007"]
["DOH-000524",13,"Sterilization","Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration"," ISO 11140-4:2007 "]
["DOH-000525",14,"Sterilization","Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests","ISO 11140-5:2007"]
["DOH-000526",15,"Sterilization","Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products","ISO 11737-1:2006"]
["DOH-000527",16,"Sterilization","Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process","ISO 11737-2:1998"]
["DOH-000528",17,"Sterilization","Aseptic processing of health care products -- Part 3: Lyophilization","ISO 13408-3:2006"]
["DOH-000529",18,"Sterilization","Aseptic processing of health care products -- Part 5: Sterilization in place","ISO 13408-5:2006"]
["DOH-000530",19,"Sterilization","Aseptic processing of health care products -- Part 6: Isolator systems","ISO 13408-6:2005"]
["DOH-000531",20,"Sterilization","Cleanrooms and associated controlled environments -- Part 8: Classification of airborne molecular contamination","ISO 14644-8:2006"]
["DOH-000532",21,"Biocompatibility","Biological evaluation of medical devices -- Guidance on a risk-management process\n","ISO/TS 20993:2006"]
["DOH-000533",22,"Sterilization","Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities","ST24:1999"]
["DOH-000534",23,"Sterilization","Table-top steam sterilizers","ST55:2003"]
["DOH-000535",24,"Sterilization","Sterilization of health care products Chemical indicators Part 2: Class 2 indicators for air removal test sheets and packs","ST66:1999"]
["DOH-000536",25,"Sterilization","Containment devices, reusable rigid sterilization containers, instrument cases, cassettes, organizing trays","ST77:2006"]
["DOH-000537",26,"Sterilization","Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results","15882:2003"]

{"sheet":"3","index":2,"n_rows":32,"n_cols":5,"rows_kept":32,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料：第三組"]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-000538",1,"Mat","外科體內植入物－金屬材料－鍛造不鏽鋼","CNS 13382-1:2004"]
["DOH-000539",2,"Mat","外科體內植入物－金屬材料－鍛造鈷－鉻－鎢－鎳合金","CNS 13382-2:2004"]
["DOH-000540",3,"Mat","外科體內植入物－金屬材料－鍛造鈷－鎳－鉻－鉬－鎢－鐵合金","CNS 13382-3:2004"]
["DOH-000541",4,"Mat","外科體內植入物－金屬材料－鍛造鈷－鎳－鉻－鉬合金","CNS 13382-4:2004"]
["DOH-000542",5,"Mat","外科體內植入物－金屬材料－鈦金屬","CNS 13382-5:2004"]
["DOH-000543",6,"Mat","外科體內植入物－金屬材料－鑄造鈷-鉻-鉬合金","CNS 13382-6:2004"]
["DOH-000544",7,"Mat","外科體內植入物－金屬材料－鍛造鈦－６鋁－４釩合金","CNS 13382-7:2004"]
["DOH-000545",8,"Mat","外科體內植入物－金屬材料－可鍛及冷作加工鈷－鉻－鎳－鉬－鐵合金","CNS 13382-8:2004"]
["DOH-000546",9,"Ortho","外科植入物–骨髓內釘系統（第二部分：骨髓釘）","CNS 13382-9:1995"]
["DOH-000547",10,"Ortho","外科植入物–骨科人工關節–基本需求","CNS 13382-10 :1995"]
["DOH-000548",11,"Ortho","外科植入物–半人工及全人工膝關節（第一部分：分類、定義及尺寸之標示）","CNS 13382-11:1995"]
["DOH-000549",12,"Ortho","外科植入物–金屬骨螺絲具有六角螺絲頭螺絲之起子接觸帽孔，球形之螺帽下表面，不對稱之螺紋–尺寸","CNS 13382-12:1995"]
["DOH-000550",13,"Ortho","外科植入物–具錐形下表面螺絲頭之金屬骨螺絲–尺寸","CNS 13382-13:1995"]
["DOH-000551",14,"Ortho","外科植入物–聚甲基丙烯酸甲脂　第一部分: 骨科應用","CNS 13382-14:1995"]
["DOH-000552",15,"Ortho","外科植入物–金屬骨板–螺絲孔適用不對稱螺紋及球形下表面之螺絲","CNS 13382-15:1995"]
["DOH-000553",16,"Ortho","外科植入物–金屬骨板–螺絲孔及槽適用於錐形下表面螺絲","CNS 13382-16:1995"]
["DOH-000554",17,"Ortho","外科植入物–骨髓內釘系統–第一部分：橫斷面為梅花狀或Ｖ型之骨髓內釘","CNS 13382-17:1995"]
["DOH-000555",18,"Mat","外科植入物–生物相容性–材料及器材之生物檢測方法的選擇（準則）","CNS 13382-18:1995"]
["DOH-000556",19,"Ortho","外科植入物–骨板彎曲強度與勁度的測定","CNS 13382-19:1995"]
["DOH-000557",20,"Ortho","外科植入物–半及全人工髖關節–第一部分：分類、尺寸標示及規定","CNS 13382-20:1995"]
["DOH-000558",21,"Ortho","外科植入物–半及全人工髖關節–第二部分：由金屬及塑膠製成之軸承面","CNS 13382-21:1995"]
["DOH-000559",22,"Ortho","外科植入物–半及全人工髖關節–第三部分：不含扭力之股骨柄耐久性測試","CNS 13382-22:1995"]
["DOH-000560",23,"Ortho","外科植入物–半及全人工髖關節–第四部分：含扭力之股骨柄耐久性測試","CNS 13382-23:1995"]
["DOH-000561",24,"Mat","外科植入物–超高分子量聚乙烯（第一部分：粉狀）","CNS 13382-24:1996"]
["DOH-000562",25,"Mat","外科植入物–超高分子量聚乙烯（第二部分：成形材）","CNS 13382-25:1996"]
["DOH-000563",26,"Ortho","外科植入物–骨針及骨線（第一部分：材料與機械特性要求）","CNS 13382-26:1996"]
["DOH-000564",27,"Ortho","外科植入物–骨針及骨線（第二部分：Ｓｔｅｉｎｍａｎｎ骨針–尺度）","CNS 13382-27:1996"]
["DOH-000565",28,"Ortho","外科植入物–骨科使用之平行腳Ｕ形釘（一般要求）","CNS 13382-28:1996"]
["DOH-000566",29,"Ortho","外科植入物–不對稱螺紋與球形底面之金屬骨螺釘（機械要求及測試方法）","CNS 13382-29:1996"]
["DOH-000567",30,"Ortho","外科植入物–成人之股骨端固定用裝置","CNS 13382-30:1996"]

{"sheet":"4","index":3,"n_rows":22,"n_cols":5,"rows_kept":22,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料：第四組 "]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-000568",1,"Anesthesia","小型醫療氣體鋼瓶－銷針標示軛式閥接頭","CNS 14961:2005"]
["DOH-000569",2,"Anesthesia","氣體鋼瓶－工業與醫療氣體鋼瓶之閥保護帽與閥保護套－設計、結構與試驗","CNS 14962:2005"]
["DOH-000570",3,"Anesthesia","醫療用氣體混合器－獨立式氣體混合器","CNS 14963:2005"]
["DOH-000571",4,"Anesthesia","醫療氣體管線系統－第１部：壓縮醫療氣體及真空用管線","CNS 15003-1:2006"]
["DOH-000572",5,"Anesthesia","醫療氣體管線系統－第２部：麻醉氣體之清理排放系統","CNS 15003-2:2006"]
["DOH-000573",6,"Anesthesia","醫療氣體管線系統使用之氧氣濃縮機","CNS 15004:2006"]
["DOH-000574",7,"Anesthesia","醫療氣體管線系統之終端單元－第１部：壓縮醫療氣體與真空用終端單元","CNS 15005-1:2006"]
["DOH-000575",8,"Anesthesia","醫療氣體管線系統之終端單元－第２部：麻醉氣體清理系統之終端單元","CNS 15005-2:2006"]
["DOH-000576",9,"Anesthesia","連接於醫療氣體管線系統終端單元之流量計裝置","CNS 15006:2006"]
["DOH-000577",10,"Software","Software engineering - Software product Quality Requirements and Evaluation (SQuaRE) - Planning and management ","ISO/IEC 25000-1:2007"]
["DOH-000578",11,"General ","Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests \n","IEC 60601-1-2 :2007"]
["DOH-000579",12,"General ","Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability ","IEC 60601-1-6:2006"]
["DOH-000580",13,"General ","Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment","CEI/IEC 60601-2-22:1995"]
["DOH-000581",14,"Radiology","Medical electrical equipment –Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices","IEC 60601-2-45 :2001"]
["DOH-000582",15,"General ","Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements ","IEC 61326-1:2005"]
["DOH-000583",16,"Radiology","Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans \n","IEC/TR 60825-8:2006"]
["DOH-000584",17,"General ","General testing procedures for medical electrical equipment \n","IEC/TR 62354:2005"]
["DOH-000585",18,"General ","Health informatics -- Digital imaging and communication in medicine (DICOM) including workflow and data management","ISO 12052:2006"]
["DOH-000586",19,"Software","Software engineering -- Software product Quality Requirements and Evaluation (SQuaRE) -- Requirements for quality of Commercial Off-The-Shelf (COTS) software product and instructions for testing ","ISO/IEC 25051:2006"]
["DOH-000587",20,"Software","Software engineering -- Software product Quality Requirements and Evaluation (SQuaRE) -- Common Industry Format (CIF) for usability test reports\n","ISO/IEC 25062:2006"]

{"sheet":"5","index":4,"n_rows":58,"n_cols":5,"rows_kept":58,"flags":["formulas_cached_only"]}
["醫療器材標準採認資料：第五組 "]
["編號","項目","類別","標準名稱","標準編號"]
["DOH-000588",1,"GPS/GH","用於人類血液和血液成品塑膠可折疊之容器－第１部：慣用容器（血袋）","CNS 15036-1:2006"]
["DOH-000589",2,"GPS/GH","電刀裝置","CNS 13460:1994"]
["DOH-000590",3,"GPS/GH","醫療用輸液設備─第一部份：玻璃點滴瓶","CNS 14624-1 :2002"]
["DOH-000591",4,"GPS/GH","醫療用輸液設備─第二部份：點滴瓶瓶塞","CNS 14624-2 :2002"]
["DOH-000592",5,"GPS/GH","醫療用輸液設備─第三部份：點滴瓶鋁蓋","CNS 14624-3 :2002"]
["DOH-000593",6,"GPS/GH","醫療用輸液設備─第四部份：單次使用之重力式輸液套","CNS 14624-4:2002"]
["DOH-000594",7,"GPS/GH","醫療用輸液設備─第五部份：量管型輸液套","CNS 14624-5 :2002"]
["DOH-000595",8,"GPS/GH","醫療用輸液設備─第六部份：點滴瓶之凍晶乾燥瓶塞\n","CNS 14624-6 :2002"]
["DOH-000596",9,"GPS/GH","醫療用輸液設備─第七部份：鋁─塑膠組合成之點滴瓶蓋","CNS 14624-7:2002"]
["DOH-000597",10,"GPS/GH","Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests","ISO 15883-1:2006  "]
["DOH-000598",11,"GPS/GH","Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.","ISO 15883-2:2006"]
["DOH-000599",12,"GPS/GH","Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers","ISO 15883-3:2006"]
["DOH-000600",13,"GPS/GH","Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy","ISO/TS 15883-5:2005"]
["DOH-000601",14,"GPS/GH","Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products","D6499-03"]
["DOH-000602",15,"GPS/GH","Standard Specification for Clinical Thermometer Probe Covers and Sheaths1","E1104-98(R2003)"]
["DOH-000603",16,"GPS/GH","Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature","E1965–98 (R 2003)"]
["DOH-000604",17,"Card","Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents","F2081-01"]
["DOH-000605",18,"Neur","Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application ","F647–94 (R2000)"]
["DOH-000606",19,"GPS/GH","Standard Specification for Silicone Elastomer Facial Implants","F881–94 (R2000)"]
["DOH-000607",20,"Neur","Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips","F1542–94 (R2000)"]
["DOH-000608",21,"GPS/GH","Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ","F1670–03"]
["DOH-000609",22,"GPS/GH","Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System ","F1671–03"]
["DOH-000610",23,"GPS/GH","Blood transfusion micro-filters","BF7:1989/(R)2002"]
["DOH-000611",24,"GPS/GH","Blood pressure transducers","BP22:1994/(R)2001"]
["DOH-000612",25,"Card","Medical electrical equipment—Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators) "," DF80:2003"]
["DOH-000613",26,"Card","Diagnostic electrocardiographic devices","EC11:1991/(R)2001"]
["DOH-000614",27,"Card","Disposable ECG electrodes","EC12:2000/(R)2005"]
["DOH-000615",28,"Card","ECG cables and leadwires","EC53:1995/(R)2001"]
["DOH-000616",29,"Card","Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms","EC57:1998/(R)2003"]
["DOH-000617",30,"Neur","Medical electrical equipment-Part 2-23:\nParticular requirements for the safety,\nincluding essential performance,\nof transcutaneous partial pressure monitoring\nequipment","60601-2-23:1999"]
["DOH-000618",31,"Card","Medical electrical equipment- Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment","60601-2-27:1994"]
["DOH-000619",32,"Card","Medical electrical equipment- Part 2-30: Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment","60601-2-30:1999"]
["DOH-000620",33,"Card","Medical electrical equipment –Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment","60601-2-34:2000"]
["DOH-000621",34,"GPS/GH","Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds ","60601-2-38:1996/Amd.1, 1999"]
["DOH-000622",35,"GPS/GH","Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements","594-1:1986"]
["DOH-000623",36,"GPS/GH","Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings","594-2:1998"]
["DOH-000624",37,"Card","Cardiac Pacemakers - Part 1 : Implantable Pacemakers","5841-1:1989"]
["DOH-000625",38,"Card","Implants for surgery — Cardiac pacemakers — Part 2:Reporting of clinical performance of populations of pulse generators or leads","5841-2:2000"]
["DOH-000626",39,"Card","Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors [IS-1] for implantable pacemakers","5841-3:2000"]
["DOH-000627",40,"Neur","Neurosurgical implants — Sterile, single use hydrocephalus shunts and components","7197:1997"]
["DOH-000628",41,"GPS/GH","Sterile single-use syringes, with or without needle, for insulin","8537:1991/Amd.1, 2000"]
["DOH-000629",42,"Neur","Intracranial pressure monitoring devices","NS28:1988/(R)2001"]
["DOH-000630",43,"GPS/GH","Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"," PB70:2003"]
["DOH-000631",44,"Card","Manual, electronic, or automated sphygmomanometers"," SP10:2002/A1:2003"]
["DOH-000632",45,"GPS/GH","Infant incubators"," II:36:1997"]
["DOH-000633",46,"OBGYN/GU","Hemodialysis systems","RD5:2003"]
["DOH-000634",47,"OBGYN/GU","Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators","RD16:2007"]
["DOH-000635",48,"OBGYN/GU","Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters","RD17:2007"]
["DOH-000636",49,"OBGYN/GU","Reuse of hemodialyzers","RD47:2002 & RD47:2002/A1:2003"]
["DOH-000637",50,"OBGYN/GU","Dialysate for hemodialysis","RD52:2004"]
["DOH-000638",51,"OBGYN/GU","Concentrates for hemodialysis","RD61:2006"]
["DOH-000639",52,"OBGYN/GU","Water treatment equipment for hemodialysis applications","RD62:2006"]
["DOH-000640",53,"GPS/GH","Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps","7886-2:1996"]
["DOH-000641",54,"GPS/GH","Sterile, single-use intravascular catheters - Part 3: Central venous catheters","10555-3:1996/ Cor.1:2002"]
["DOH-000642",55,"GPS/GH","Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters","10555-5:1996/Amd.1:1999, Cor.1:2002"]
["DOH-000643",56,"GPS/GH","非侵入式自動血壓計","CNS 13075:2007"]