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{"sheet":"第一組","index":0,"n_rows":59,"n_cols":5,"rows_kept":59,"cut":false,"hidden":false,"merged":[[0,0,0,4]],"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-00168",1,"InVitro","Specifications for Immunological Testing for Infectious Diseases; Approved Guideline","I/LA18-A 1994"]
["DOH-00169",2,"InVitro","Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline","MM3-A 1995"]
["DOH-00170",3,"InVitro","Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994)","C12-A"]
["DOH-00171",4,"InVitro","Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992)","C21-A"]
["DOH-00172",5,"InVitro","Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997)","C25-A"]
["DOH-00173",6,"InVitro","Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993)","C27-A"]
["DOH-00174",7,"InVitro","Ancillary (Bedside) Blood Glucose Testing","C30-A"]
["DOH-00175",8,"InVitro","Erythrocyte Protoporphyrin Testing; Approved Guideline (1996)","C42-A"]
["DOH-00176",9,"InVitro","Solubility Test to Confirm the Presence of Sickling Hemoglobins - Second Edition; Approved Standard (1995)","H10-A2"]
["DOH-00177",10,"InVitro","Devices for Collection of Skin Puncture Blood Specimens - Second Edition; Approved Guideline (1990)","H14-A2"]
["DOH-00178",11,"InVitro","Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard (1992)","H20-A"]
["DOH-00179",12,"InVitro","Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes); Approved Guideline (1997)","H44-A"]
["DOH-00180",13,"InVitro","One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996)","H47-A"]
["DOH-00181",14,"InVitro","Quality Assurance for the Indirect Immunoflurescence Test for Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline (1996)","I/LA2-A"]
["DOH-00182",15,"InVitro","Detection and Quantitation of Rubella IGG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline (1997)","I/LA6-A"]
["DOH-00183",16,"InVitro","Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996)","I/LA10-A"]
["DOH-00184",17,"InVitro","Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline (1997)","I/LA17-A"]
["DOH-00185",18,"InVitro","Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997)","I/LA19-A"]
["DOH-00186",19,"InVitro","Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (1997)","I/LA20-A"]
["DOH-00187",20,"InVitro","Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard","H26-A"]
["DOH-00188",21,"InVitro","Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition","H15-A3"]
["DOH-00189",22,"InVitro","Clinical Application of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes; Approved Guideline","H42-A"]
["DOH-00190",23,"InVitro","Clinical Evaluation of Immunoassays; Approved Guideline","I/LA21-A"]
["DOH-00191",24,"InVitro","Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard","M6-A"]
["DOH-00192",25,"InVitro","Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline","M15-A"]
["DOH-00193",26,"InVitro","Quality Assurance for Commerically Prepared Microbiological Culture Media - Second Edition; Approved Standard","M22-A2"]
["DOH-00194",27,"InVitro","Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline","M23-A"]
["DOH-00195",28,"InVitro","Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline","M28-A"]
["DOH-00196",29,"InVitro","Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline","MM1-A"]
["DOH-00197",30,"InVitro","Blood Gas and pH Analysis and Related Measurements; Approved Guideline","C46-A"]
["DOH-00198",31,"InVitro","Clinical Applications of Flow Cytometry:\nImmunophenotyping of Leukemic Cells; Approved Guideline","H43-A"]
["DOH-00199",32,"InVitro","Immunoglobulin and T-Cell Receptor\nGene Rearrangement Assays; Approved Guideline","MM2-A"]
["DOH-00200",33,"InVitro","In vitro diagnostic test systems -Requirements for blood-glucose\nmonitoring systems for self-testing in\nmanaging diabetes mellitus",15197]
["DOH-00201",34,"InVitro","Glossary and Guidelines for Immunodiagnostic Procedures, Reagents and Reference Materials-Second Edition","DI1-A2"]
["DOH-00202",35,"InVitro","Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline\n","MM-5A"]
["DOH-00203",36,"IVD","Statistical Quality Control for Quantitative Measurements: Principles and Definitions: Approved Guideline - Second Edition (1999)","C24-A2"]
["DOH-00204",37,"IVD","Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard (2000)","C29-A2"]
["DOH-00205",38,"IVD","Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition (2001)","C31-A2"]
["DOH-00206",39,"IVD","Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials - Second Edition; Approved Guideline","DI02-A2"]
["DOH-00207",40,"IVD","Tubes and Additives for Venous Blood Specimen Collection; Approved Standard","H1-A5"]
["DOH-00208",41,"IVD","Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture; Approved Standard - Fourth Edition","H4-A4"]
["DOH-00209",42,"IVD","Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition","H7-A3"]
["DOH-00210",43,"IVD","Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition","H30-A2"]
["DOH-00211",44,"IVD","Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline","H51-A"]
["DOH-00212",45,"IVD","Assessing the Quality of Radioimmunoassay Systems - Second Edition; Approved Guideline","NCCLS LA01-A2"]
["DOH-00213",46,"IVD","Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - 8th Edition","M2-A8"]
["DOH-00214",47,"IVD","Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically`; Approved Standard - Sixth Edition","M7-A6"]
["DOH-00215",48,"IVD","Methods for Antimicrobial Susceptibility Tests of Anaerobic Bacteria; Approved Standard -- Sixth Edition","M11-A6"]
["DOH-00216",49,"IVD","Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard","M24-A"]
["DOH-00217",50,"IVD","Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline","M26-A"]
["DOH-00218",51,"IVD","Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard (1997). ","M27-A"]
["DOH-00219",52,"IVD","Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard—Second Edition","M31-A2"]
["DOH-00220",53,"IVD","THE NATIONAL REFERENCE SYSTEM FOR THE CLINICAL LABORATORY (NRSCL) ASPARTATE AMINOTRANSFERASE (AST)","RS2-A"]
["DOH-00221",54,"IVD","THE NATIONAL REFERENCE SYSTEM FOR THE CLINICAL LABORATORY (NRSCL) CHOLESTEROL","RS3-A"]
["DOH-00222",55,"IVD","THE NATIONAL REFERENCE SYSTEM FOR THE CLINICAL LABORATORY (NRSCL) TOTAL PROTEIN","RS5-A2"]
["DOH-00223",56,"IVD","THE NATIONAL REFERENCE SYSTEM FOR THE CLINICAL LABORATORY (NRSCL) TOTAL BILIRUBIN","RS6-A"]
["DOH-00224",57,"IVD","Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (1997)","T/DM6-A"]

{"sheet":"第二組","index":1,"n_rows":17,"n_cols":5,"rows_kept":17,"cut":false,"hidden":false,"merged":[[0,0,0,4]],"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-00225",1,"Sterility","Hospital Steam Sterilizers","ST8:2001"]
["DOH-00226",2,"Sterility","Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method","6.2.02:2005"]
["DOH-00227",3,"Sterility","Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method","6.2.03:2005"]
["DOH-00228",4,"Sterility","Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method","6.2.05:2005"]
["DOH-00229",5,"Sterility","Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes","6.3.02:2005"]
["DOH-00230",6,"Sterility","Official Method 966.04, Sporicidal Activity of Disinfectants","6.3.05:2005"]
["DOH-00231",7,"Sterility","Official Method 965.12, Tuberculocidal Activity of Disinfectants","6.3.06:2005"]
["DOH-00232",8,"Sterility","Dry heat (heated air) sterilizers","ST50:2004"]
["DOH-00233",9,"Sterility","Sterilization of medical devices - Validation and routine control of sterilisation by irradiation",14709]
["DOH-00234",10,"Biocomp","Biological evaluation of medical devices - Part 7: ethylene oxide sterilisation residuals ","14393-7 "]
["DOH-00235",11,"Biocomp","Biological evaluation of medical devices ? Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)","14393-8"]
["DOH-00236",12,"Biocomp","Biological evaluation of medical devices - Part 10 : tests for irritation and sensitisation ","14393-10"]
["DOH-00237",13,"Biocomp","Biological evaluation of medical devices - Part 12 : sample preparation and reference materials ","14393-12"]
["DOH-00238",14,"Biocomp","Biological evaluation of medical devices - Part 6: Tests for local effects after implantation ","14393-6"]
["DOH-00239",15,"Biocomp","Biological evaluation of medical devices - Part 11: tests for systemic toxicity"," 14393-11"]

{"sheet":"第三組","index":2,"n_rows":24,"n_cols":5,"rows_kept":24,"cut":false,"hidden":false,"merged":[[0,0,0,4]],"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-00240",1,"Dental/ENT","Dental Casting Gold Alloys","1562:1993"]
["DOH-00241",2,"Dental/ENT","Dental Alginate Impression Material","1563:1990"]
["DOH-00242",3,"Dental/ENT","Dental Aqueous Impression Materials Based on Agar","1564:1995"]
["DOH-00243",4,"Dental/ENT","Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol Cements","3107:1988"]
["DOH-00244",5,"Dental/ENT","Dental base metal casting alloys Part 1: Cobalt-based alloys - TECHNICAL CORRIGENDUM 1:1998","6871-1:1994"]
["DOH-00245",6,"Dental/ENT","Dental Base Metal Casting Alloys Part 2: Nickel-Based Alloys","6871-2:1994"]
["DOH-00246",7,"Dental/ENT","Dental Ceramic","6872:1995, Amendment 1-1997"]
["DOH-00247",8,"Dental/ENT","Dental Resin-Based Pit and Fissue Sealants","6874:1988"]
["DOH-00248",9,"Dental/ENT","Dental Root Canal Sealing Materials","6876:2001"]
["DOH-00249",10,"Dental/ENT","Dental Root-Canal Obturating Points","6877:1995"]
["DOH-00250",11,"Dental/ENT","Dentistry - Polymer-Based Crown and Bridge Materials","10477:1996"]
["DOH-00251",12,"Dental/ENT","Dental Handpieces: Dental Low Voltage Electrical Motors","11498:1997"]
["DOH-00252",13,"Dental/ENT","Dental Handpieces - Dental Air-Motors","13294:1997"]
["DOH-00253",14,"Dental/ENT","Dental Casting Alloys with Noble Metal Content of At Least 25% but less than 75%","8891:2000"]
["DOH-00254",15,"Dental/ENT","Metal-Ceramic Dental Restorative Systems","9693:1999"]
["DOH-00255",16,"Dental/ENT","Dental Water-Based Cements - Part 2: Light-Activated Cements","9917-2:1998"]
["DOH-00256",17,"Dental/ENT","Dentistry - Reversible-Irreversible Hydrocolloid Impression Material Systems","13716:1999"]
["DOH-00257",18,"Dental/ENT","Dental Water-Based Cements - Part 1: Powder/Liquid Acid-Base Cements - First Edition","9917-1:2003"]
["DOH-00258",19,"Dental/ENT","Dentistry - Resilient Lining Materials for Removable Dentures Part 1: Short-Term Materials","10139-1:1991"]
["DOH-00259",20,"Dental/ENT","Dentistry - Resilient lining materials for removable dentures - Part 2: Materials for long-term use","10139-2:1999"]
["DOH-00260",21,"Dental/ENT","Dentistry - Dental units - Part 1: General requirements and test methods","7494-1:1996"]
["DOH-00261",22,"Material","Implants for surgery — Active implantable medical devices —Part 1: General requirements for safety, marking and for information to be provided by the manufacturer","14708-1: 2000"]

{"sheet":"第四組","index":3,"n_rows":27,"n_cols":5,"rows_kept":27,"cut":false,"hidden":false,"merged":[[0,0,0,4]],"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-00262",1,"Anesthesia","Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components1","F 1850-00"]
["DOH-00263",2,"Radiology","Medical Electrical Equipment - Part 2-7: Particular Requirements for the Safety of High-voltage Generators of Diagnostic X-ray Generators (1998)","60601-2-7"]
["DOH-00264",3,"Radiology","Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors - Ed. 2.0","60601-2-9(1996-10)"]
["DOH-00265",4,"Anesthesia","Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans","F920-93(1999)"]
["DOH-00266",5,"Anesthesia","Standard Specification for Ventilators Intended for Use in Critical Care","F1100-90(1997)"]
["DOH-00267",6,"Radiology","Radiation protection - Sealed radioactive sources - General requirements and classification","2919(1999)"]
["DOH-00268",7,"Radiology","Medical Electrical Equipment - Dosimeters with Ionization chambers as used in radiotherapy","60731-1997"]
["DOH-00269",8,"Anesthesia","Standard Specification for Ventilators Intended for Use During Anesthesia","F1101-90(2003)e1"]
["DOH-00270",9,"Anesthesia","Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications","G175-03"]
["DOH-00271",10,"Anesthesia","Standard Specification for Minimum Performance and Safety Requirements for Capnometers","F1456-01"]
["DOH-00272",11,"Radiology","Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices","60601-2-45 Ed. 2.0, (2001-05)"]
["DOH-00273",12,"Radiology","Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment","60601-2-22 (1995-11) - Ed. 2.0"]
["DOH-00274",13,"Radiology","Optics and optical Instruments - Lasers and laser-related equipment - Test method for the laser-resistance of surgical drapes and/or patient-protective covers","11810-1:2005"]
["DOH-00275",14,"Radiology","Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in x-ray diagnostic imaging","61674 (1997-10)"]
["DOH-00276",15,"Radiology","Lasers and laser-related equipment - Test methods for laser beam parameters - Beam widths, divergence angle and beam propagation factor","11146:1999"]
["DOH-00277",16,"Radiology","Lasers and laser-related equipment - Determination of laser-induced damage threshold of optical surfaces - Part 1: 1-on-1 test","11254-1:2000"]
["DOH-00278",17,"Radiology","Lasers and laser-related equipment - Determination of laser-induced damage threshold of optical surfaces - Part 2: S-on-1 test","11254-2:2001"]
["DOH-00279",18,"Radiology","Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components","11551:2003"]
["DOH-00280",19,"Radiology","Optics and optical instruments - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics","11554:2003"]
["DOH-00281",20,"Radiology","Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability","11670:2003"]
["DOH-00282",21,"Radiology","Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization","12005:2003"]
["DOH-00283",22,"Radiology","Optics and optical instruments -- Test methods for radiation scattered by optical components","13696:2002"]
["DOH-00284",23,"Radiology","Medical Electrical Equipment--Part 1-3: General Requirements for Safety-Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment","14509-3"]
["DOH-00285",24,"General","Clinical investigation of medical devices for human subjects —\nPart 1: General requirements","ISO 14155-1"]
["DOH-00286",25,"General","Clinical investigation of medical devices for human subjects —\nPart 2: Clinical investigation plans","ISO 14155-2"]

{"sheet":"第五組","index":4,"n_rows":33,"n_cols":5,"rows_kept":33,"cut":false,"hidden":false,"merged":[[0,0,0,4]],"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-00287",1,"GPS/GH","Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions","595/1 "]
["DOH-00288",2,"GPS/GH","Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests","595/2 "]
["DOH-00289",3,"GPS/GH","Sterile hypodermic needles for single use","7864:1993"]
["DOH-00290",4,"GPS/GH","Amendment 1 - Medical electrical equipment Part 2: Particular requirements for safety of baby incubators","60601-2-19 1996-10:"]
["DOH-00291",5,"GPS/GH","Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment","60601-2-2- 1998-09 Ed. 3.0:"]
["DOH-00292",6,"GPS/GH","Standard Test Method for Detection of Holes in Medical Gloves","D5151-99"]
["DOH-00293",7,"GPS/GH","Stainless steel needle tubing for the manufacture of medical devices","9626, First Edition, 1991-09-01"]
["DOH-00294",8,"GPS/GH","Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature","E1112-00"]
["DOH-00295",9,"GPS/GH","Standard Test Method for Residual Powder on Medical Gloves","D6124-01"]
["DOH-00296",10,"GPS/GH","Standard Specification for Rubber Examination Gloves","D3578-01ae2"]
["DOH-00297",11,"GPS/GH","Standard Specification for Rubber Surgical Gloves","D3577-01ae2"]
["DOH-00298",12,"GPS/GH","Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus",14775]
["DOH-00299",13,"GPS/GH","Standard Specification for Natural Rubber Finger Cots","D3772-01"]
["DOH-00300",14,"Surgery","Standard Performance and Safety Specification for Cryosurgical Medical Instruments","F882-84(2002)"]
["DOH-00301",15,"GPS/GH","Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes","F754-00"]
["DOH-00302",16,"Surgery","Standard Specification for Soft-Tissue Expander Devices","F1441-03"]
["DOH-00303",17,"GPS/GH","Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods","11608-1:2000"]
["DOH-00304",18,"GPS/GH","Pen-injectors for medical use - Part 2: Needles - Requirements and test methods","11608-2:2000"]
["DOH-00305",19,"GPS/GH","Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods","11608-3:2000"]
["DOH-00306",20,"GPS/GH","Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers","F2172-02:"]
["DOH-00307",21,"GPS/GH","Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices","F2196-02:"]
["DOH-00308",22,"GPS/GH","Transfusion equipment for medical use - Part 4: Transfusion sets for single use","1135-4-2004:"]
["DOH-00309",23,"GPS/GH","Medical Electrical Equipment--Part 1: General Requirements for Safety",14509]
["DOH-00310",24,"GPS/GH","Medical Electrical Equipment--Part 1-1: General Requirements for Safety-Collateral Standard: Safety Requirements for Medical Electrical systems","14509-1"]
["DOH-00311",25,"GPS/GH","Medical Electrical Equipment--Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests","14509-2"]
["DOH-00312",26,"GPS/GH","Medical Electrical Equipment--Part 1-4: General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems","14509-4"]
["DOH-00313",27,"Card","Medical electrical equipment, Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source","60601-2-31 (1994)"]
["DOH-00314",28,"Card","Cardiac Defibrillators - Connector Assembly for Implantable Defibrillators - Dimensional and Test Requirements","11318:1993/Amd. 1:1996(E)"]
["DOH-00315",29,"Card","Medical Electrical Equipment-Part 2, Particular Requirements for the Safety of Electrocardiographs","60601-2-25"]
["DOH-00316",30,"Card","Medical Electrical Equipment Part 2-47: Particular Requirements for the Safety, including Essential Performance of Ambulatory Electrocardiographic Systems","60601-2-47"]
["DOH-00317",31,"Card","Particular Requirements for the Safety of Cardiac Defibrillator","60601-2-4"]