국제규격가이드라인개발현황 ('12 ~ '15 년 ) 순번규격번호 / 구분규격명 1 IEC 60127-1 2 IEC 60086-4 3 IEC 60112 Miniature fuses Part 1:Definitions for miniature fuses and general requirements for miniature fuse-links Primary batteries Part 4: Safety of lithium batteries Method for the determination of the proof and the comparative tracking indices of solid insulating materials 4 IEC 60085 Electrical insulation Thermal evaluation and designation 5 IEC 60601-1-3 6 IEC 60601-1-6 7 IEC 60601-1-8 8 IEC 60601-1-11 9 IEC 60601-2-10 10 IEC 60601-2-18 11 IEC 60601-2-24 12 IEC 60601-2-25 13 IEC 60601-2-34 14 IEC 60601-2-49 15 IEC 61010-1 16 IEC 61326-1 17 CEI IEC 61010-2-101 18 IEC 61326-2-6 19 CEI IEC 61010-2-20 20 ISO 3864-1 Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment Part 2-24: Particular requirements for the safety of infusion pumps and controllers Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for in vitro diagnostic(ivd) medical equipment Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-020: Particular requirements for laboratory centrifuges Graphical symbols Safety colours and safety signs Part 1:Design principles for safety signs and safety markings 21 ISO 7010 Graphical symbols Safety colours and safety signs Registered safety signs 22 ISO 15223-1 23 ISO 11607-1 24 ISO 11607-2 25 ISO 9241-302 26 ISO/TS 9241-411 27 ISO/TR 16142 28 ISO 9022-2 29 ISO 9022-3 30 ISO 15004-1 31 ISO 15004-2 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes Ergonomics of human-system interaction Part 302: Terminology for electronic visual displays Ergonomics of human-system interaction Part 411: Evaluation methods for the design of physical input devices Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices Optics and optical instruments Environmental test methods Part 2: Cold, heat and humidity Optics and optical instruments Environmental test methods Part 3: Mechanical stress Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection 32 ISO 10341 Ophthalmic instruments Refractor heads 33 ISO 8429 Optics and optical instruments- Ophthalmology-Graduated dial scale 34 ISO 80601-2-35 35 ISO 80601-2-60 36 ISO 80601-2-12 37 ISO 80601-2-55 38 ISO 80601-2-56 Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use Part 2-60 Particular requirements for the basic safety and essential performance of dental equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 39 ISO 10555-1 Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements
40 ISO 10555-2 41 ISO 10555-3 42 ISO 10555-4 43 ISO 10555-5 Sterile, single-use intravascular catheters - Part 2: Angiographic catheters Intravascular catheters Sterile and single-use catheters Part 3: Central venous catheters Intravascular catheters Sterile and single-use catheters Part 4: Balloon dilatation catheters Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters 44 ISO 14972 Sterile obturators for single use with overneedle peripheral intravascular catheters 45 ISO 3107 Dentistry Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements 46 ISO 10139-2 Dentistry Soft lining materials for removable dentures Part 2: Materials for long-term use 47 ISO 6876 Dentistry Root canal sealing materials 48 ISO 15197 49 ISO 17511 50 ISO 15193 51 ISO 15194 52 ISO/TR 18112 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus In vitro diagnostic medical devices Measurement of quantities in biologicalsamples Metrological traceability of values assigned to calibrators and control materials In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation 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 53 EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice 54 EN ISO 14602 Non-active surgical implants - Implants for osteosynthesis - Particular requirements 55 EN ISO 80601-2-61 56 MEDDEV 2.1_1 57 MEDDEV 2.1_5 58 MEDDEV 2.2.1 59 MEDDEV 2.2.3 60 MEDDEV 2.4_1 61 MEDDEV 2.7_1 62 MEDDEV 2.12_1 63 MEDDEV 2.12_2 64 MEDDEV 2.1.6 65 MEDDEV 2.7_4 66 MEDDEV 2.1.3.7 67 MEDDEV 2.1.2.1.02 68 BS EN 12470-2:2000+A1:2009 69 BS EN 12470-3:2000+A1:2009 70 BS EN 12470-4:2000+A1:2009 71 BS EN 12470-5 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Definition of Medical device 의료기기, 액세서리, 제조자정의가이드라인 Medical devices with measuring function 측정기능을가진의료기기가이드라인 EMC requirements EMC 요구사항가이드라인 Used by Date 사용기한가이드라인 classification 의료기기등급구분가이드라인 clinical evaluation 임상평가가이드라인 Vigilance system 의료기기사후관리시스템가이드라인 post market clinical follow up 판매후임상적사후관리가이드라인 Standard alone software 독립소프트웨어의인정및분류가이드라인 clinical investigation 제조자및인증기관을위한임상조사가이드라인 interface with other directives 다른지침들과의상호관계가이드라인 treatment of computer used to program implantable pulse generator 이식가능한펄스발생기를프로그램하기위해사용되는컴퓨터가이드라인 Clinical thermometers Part 2: Phase change type (dot matrix) thermometers Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Clinical thermometers Part 4:Performance of electrical thermometers for continuous measurement Clinical thermometers Part 5: Performance of infra-red ear thermometers (with maximum device) 72 BS EN 980 Symbols for use in the labelling of medical devices 73 BS EN 1041 Information supplied by the manufacturer with medical devices 74 GB 9706.1 75 GB 9706.3 76 GB 12257 77 GB 10010 78 GB 10152 79 GB 9706.22 80 GB 9706.18 81 중국 YY0065 82 중국 YY 0017 83 중국 YY 0323 84 중국 YY 1116 85 중국 YY 0307 86 중국 YY 0178 87 중국 YY0285.1 의료용전기설비제 1 부 : 안전공통요구가이드라인 Part 1: General requirements for basic safety and essential performance 의료용전기설비제2부분 : 진단용 X선발생장치고전압발생기안전전용요구가이드라인 Medical electrical equipment Part2:Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators 헬륨네온레이저치료기일반기술조건가이드라인 General specification of He-Ne laser medical equipment 의료용연성 PVC 튜브원자재가이드라인 Plasticized polivinyl chloride(pvc) tubing for medical use B형초음파진단설비가이드라인 B mode ultrasonic diagnostic equipment 의료용전기설비제2부분 : 체외충격파쇄석기안전전용요구가이드라인 Medicalelectricalequipment Part2:Particularr equirements for the safety of equipment for extracorporeally induced lithotripsy 의료용전기설비제2부분 : X선전산화단층촬영설비안전전용요구가이드라인 Medicalelectricalequipment Part2:Particularr equirements for the safety of X-ray equipment for computed tomography 안과기기틈새등현미경가이드라인 Ophthalmic instruments Slit-lamp microscopes 골접합용이식금속접골판가이드라인 implants for osteosynthesis Metallic bone plates 적외선치료설비안전전용요구가이드라인 Particular requirements for the safety of infrared therapy equipment 흡수가능한외과봉합사가이드라인 Absorbable surgical suture 연속이트륨석류석레이저치료기일반기술조건가이드라인 Nd-Yag Laser equipment -General requirement 안과기기검영기가이드라인 Opthalmic instruments Retinoscopes 일회용무균혈관내카테터제1부 : 일반요구사항가이드라인 Sterile,single-use intravascular catheters Part1:General requirements
88 중국 YY 1090 89 중국 YY/T 0724 90 중국 YY/T 0196 91 중국 YY/T 0664 92 중국 YY/T 0741 93 중국 YY/T 0316 초음파물리치료설비가이드라인 Ultrasonic physiotherapy equipment 이중에너지 X선골밀도측정기전용기술조건가이드라인 Particular specifications for dual energy X-ray bone densitometer 일회용심전도전극가이드라인 Disposable ECG electrodes 의료기기소프트웨어소프트웨어생존주기과정가이드라인 Medical device software Software life cycle processes 디지털의료용 X선촬영시스템전용기술조건 General specifications for digital medical X-ray radiography system 의료기기의료기기에대한위험관리의적용가이드라인 Medical devices - Application of risk management to medical devices 94 중국 Guidance 3 등급의료용 X 선진단시스템제품등록기술심사가이던스해설서 95 중국 Guidance 초음파영상진단설비 (3 등급 ) 제품등록기술심사가이드라인 96 중국 Guidance 자가측정용혈당시스템등록신청자료가이던스해설서 97 중국 Guidance 의료용네뷸라이저제품등록기술심사가이던스해설서 98 중국 Guidance 종양표지자정량측정스트립가이던스해설서 Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement 99 Devices #G90-2 (blue book memo) 전기전자의료기기진단용초음파장치, 부속품및측정장비에관한제출문서에대한통합검토 Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic 100 Ultrasound Systems and Transducers 전기전자의료기기진단용초음파시스템및프로브의판매허가를원하는제조업체를위한정보 Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment 101 전기전자의료기기국내및해외진단용엑스선장치제조업체의점검 Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) 102 Requirements 전기전자의료기기진단용엑스선장치제조업체및조립기술자에대한전자동콜리메이터 (PBL) 요구사항 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) part 1 103 전기전자의료기기진단용엑스선장치에서의방사선관리기준에대한설명파트 1 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) part 2 104 전기전자의료기기진단용엑스선장치에서의방사선관리기준에대한설명파트 2 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) part 3 105 전기전자의료기기진단용엑스선장치에서의방사선관리기준에대한설명파트 3 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) part 4 106 전기전자의료기기진단용엑스선장치에서의방사선관리기준에대한설명파트 4 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) part 5 107 전기전자의료기기진단용엑스선장치에서의방사선관리기준에대한설명파트 5 Inspection and Field Testing of Radiation-Emitting Electronic Products 108 전기전자의료기기방사선성전자제품의점검및현장검사 Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 109 1020.33); Small Entity Compliance Guide 전기전자의료기기진단용엑스선장치및주요부품을위한성능기준규격 Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling 110 전기전자의료기기전자제품표시내 URL 추가에대한가이던스 Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals 111 전기전자의료기기전자제품사용자설명서에허용되는미디어 Imports Radiation-Producing Electronic Products (FDA 89-8008) 112 전기전자의료기기방사선성전자제품수입 Guidance for Industry and Food and Drug Administration Staff -Assembler's Guide to Diagnostic X-Ray Equipment 113 전기전자의료기기조립자를위한진단용엑스레이장비안내서 Guidance for Industry and FDA Staff Dental Handpieces -Premarket Notification [510(k)] Submissions 114 의료용핸드피스치과용핸드피스 시장출하전신고서 [510(k)] 제출 Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 115 Software Validation 의료기기에서의기성품소프트웨어사용 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 116 Software Validation 의료기기에들어가는소프트웨어의출시전제출내용에관한지침서 General Principles of Software Validation; Final Guidance for Industry and FDA Staff 117 Software Validation 소프트웨어밸리데이션의일반원칙 Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management 118 Risk Management 의료기기사용안전 : 인적요소엔지니어링을위험관리에포함 Do It By Design - An Introduction to Human Factors in Medical Devices 119 Risk Management 의료기기에대한인적요소소개 Decorative, Non-corrective Contact Lenses 120 의료용품미용목적의무보정콘택트렌즈 ( 소프트콘택트렌즈 ) Guidance for Industry and FDA Staff: Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear 121 의료용품연속착용을위한 3등급산소투과콘택트렌즈 (RGP) 의승인된시판전승인신청서에렌즈마무리공정실험실을추가하기 ( 소프트콘택트렌즈 ) 위한절차서 Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses 122 의료용품매일착용콘택트렌즈에관한시판전신고 (510k) 지침문서의개정 ( 소프트콘택트렌즈 ) Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses 123 의료용품매일착용콘택트렌즈에관한시판전신고 (510k) 지침문서의개정 ( 소프트콘택트렌즈 ) Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses 124 의료용품매일착용콘택트렌즈에관한시판전신고 (510k) 지침문서의개정 ( 소프트콘택트렌즈 ) Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses 125 의료용품매일착용콘택트렌즈에관한시판전신고 (510k) 지침문서의개정 ( 소프트콘택트렌즈 ) Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental 126 Implants and Endosseous Dental Abutments 치과용임플란트치근형골내임플란트및골내지대주 Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Text Only) 127 주사기피스톤식주사기의시판전신고 ((510(k)) 제출문서대한지침서 Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular 128 Stents and Associated Delivery Systems 스텐트혈관내스텐트및관련전달시스템에대한비임상적공학기술시험및권고되는표시기재사항 Guidance for Industry and FDA Staff: Spinal System 510(k)s 129 추간체보정고형제척추시스템 510(k) 130 Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems 추간체보정고형제척추시스템에대한 IDE 작성을위한지침문서
131 ASTM-F 1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages1 132 ASTM-D 903 Standard Test Method for Peel or Stripping Strength of Adhesive Bonds 133 ASTM-D 1084 Standard Test Methods for Viscosity of Adhesives 134 ASTM-D 3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission 135 ASTM-D 4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method 136 ASTM-F 1585 Standard Guide for Integrity Testing of Porous Barrier Medical Packages 137 F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection 138 ASTM- F 1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration 139 ASTM-F 2392 Standard Test Method for Burst Strength of Surgical Sealants 140 ASTM-F 88 Standard Test Method for Seal Strength of Flexible Barrier Materials 141 ASTM- D 4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing 142 ASTM-F 1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) 143 ASTM-D 882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting 144 ASTM-D 4169 Standard Practice for Performance Testing of Shipping Containers and Systems 145 ASTM-F 2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method 146 ASTM-F 2638 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier 147 ASTM-F 746 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials 148 ASTM-F 2052-06e1 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment 149 ASTM-F 2079 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents 150 ASTM-F 2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents 151 ASTM-F 2119-01 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants 152 ASTM-F 2129 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices 153 ASTM-F 2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 154 ASTM-F 2394 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System 155 ASTM-F 2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 156 ASTM-G 15-02 Standard terminology relating to corrosion and corrosion testing 157 ASTM-G 61 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys 158 ASTM-G 71 Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes 159 ASTM-G 102 Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements 160 ASTM-F 67 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) 161 ASTM-F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) 162 IEC 60601-1-8 Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 163 IEC 60601-2-10 Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators 164 IEC 60601-2-18 Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment 165 IEC 60601-2-24 Part 2-24: Particular requirements for the safety of infusion pumps and controllers 166 IEC 60601-2-25 Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs 167 IEC 60601-2-34 Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment 168 IEC 60601-2-49 Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment 169 IEC 60601-2-43 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures 170 IEC 60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment 171 IEC 60601-2-65 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment 172 IEC 60601-1 Part 1: General requirements for basic safety and essential performance 173 IEC 60601-2-22 Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment 174 IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 175 IEC 60601-2-44 Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography 176 IEC 60601-2-1 Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV 177 IEC 60601-2-3 Part 2: Particular requirements for the safety of short-wave therapy equipment 178 IEC 60601-2-5 Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment 179 IEC 60601-2-6 Medical electrical equipment. Part 2: Particular requirements for the safety of microwave therapy equipment
180 IEC 60601-2-23 Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment 181 IEC 60601-2-27 Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 182 IEC 60601-2-50 Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment_corrigendum (2010-08) 183 IEC 60601-2-66 Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems 184 IEC 60601-2-47 Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems 185 IEC 60601-2-26 Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 186 IEC 60601-2-39 Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment 187 IEC 60601-2-46 Part 2-46: Particular requirements for basic safety and essential performance of operating tables 188 IEC 60601-2-52 Part 2-52: Particular requirements for the basic safety and essential performance of medical beds _Corrigendum 1 (2010-09) 189 IEC 60601-2-21 Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers 190 IEC 60601-2-2 Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 191 IEC 60601-2-4 Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators 192 IEC 60601-2-8 Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kv to 1 MV 193 IEC 60601-2-16 Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment 194 IEC 60601-2-19 Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators 195 IEC 60601-2-20 Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators 196 IEC 60601-2-28 Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis 197 IEC 60601-2-29 Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators 198 IEC 60601-2-31 Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 199 IEC 60601-2-33 Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis 200 IEC 60601-2-37 Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 201 IEC 60601-2-41 Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis 202 IEC 60601-2-45 Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 203 IEC 60601-2-54 Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 204 IEC 60601-1 (3판) 용어집 Medical electrical equipment Nomenclature 205 IEC 62366 Application of usability engineering process to medical device 206 ISO 80601-2-35 Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use 207 ISO 80601-2-60 Part 2-60 Particular requirements for the basic safety and essential performance of dental equipment 208 ISO 80601-2-12 Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators 209 ISO 80601-2-55 Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 210 ISO 80601-2-56 Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 211 ISO 80601-2-58 Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery 212 ISO 14708-1 Implants for surgery Activei mplantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 213 ISO 80601-2-13 Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation 214 ISO 80601-2-30 Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
215 ISO 80601-2-59 Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening 216 ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 217 ISO 7405 Dentistry Evaluation of biocompatibility of medical devices used in dentistry 218 ISO/TS 20993 Biological evaluation of medical devices Guidance on a riskmanagement process 219 ISO 22442-1 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management 220 ISO 14644-1 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness 221 ISO 14644-4 Cleanrooms and associated controlled environments Part 4: Design, construction and start-up 222 ISO 14644-5 Cleanrooms and associated controlled environments Part 5: Operations 223 ISO 80601-2-61 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 224 MEDDEV 2.5-7 rev 1 Conformity assessment of breast implants 유방보형물이식의적합성평가 225 MEDDEV. 2.5/9 rev 1 Evaluation of medical devices incorporating products containing natural rubber latex 천연고무라텍스를포함하는의료기기 226 MHRA Guidance European Regulatory Affairs, GUIDANCE ON THE BIOLOGICAL SAFETY ASSESSMENT 의료기기생물학적안전성평가 227 중국 GB/T 19634 체외진단검사시스템자가진단용혈당모니터시스템공통기술조건 In vitro diagnostic test systems General technical requirements for blood-glucose monitoring systems for self-testing 228 중국 YY 0109 의료용초음파네뷸라이저 Medical ultrasonic nebulizer 229 중국 Guidance X선진단장비 (2등급) 제품등록기술심사가이드라인 230 중국 Guidance B형초음파진단기기 (2등급) 제품등록기술심사가이드라인 231 중국 Guidance 초음파물리치료설비제품등록기술심사가이드라인 232 중국 Guidance 3A급반도체레이저치료기제품등록기술심사평가가이드라인 233 중국 GB 12257 He-Ne 레이저치료기공통기술조건 General specification of He-Ne laser medical equipment 234 중국 Guidance 초음파도플러태아감시장치제품등록기술심사가이드라인 235 중국 YY 0449 초음파도플러태아감시장치 Ultrasonic Doppler Fetal Monitor 236 중국 Guidance 멀티채널환자감시장치가이던스 237 중국 YY 1079 심전도모니터 Electrocardiographic monitors 238 중국 Guidance 다기능환자감시장치제품등록기술심사가이드라인 239 중국 Guidance 치과용임플란트 ( 시스템 ) 제품등록기술심사가이드라인 240 중국 GB/T 13810 외과임플란트용티타늄및티타늄합금가공재 Wrought titanium and titanium alloy for surgical implants 241 중국 Guidance 마취기및호흡기용튜브제품등록기술심사가이드라인 242 중국 YY 0461 Breathing tubes intended for use with aneasthetic apparatus and ventilators 마취기및호흡기용튜브 243 중국 Guidance 효소결합면역측정시약등록기술심사가이드라인 244 중국 YY1183 효소결합면역흡착법 (ELISA) 측정시약 ( 키트 ) Detection reagent(kit) for enzyme-linked immunoabsorbent assay (ELISA) 245 중국 Guidance 혈당측정기제품등록기술심사가이드라인 246 중국 Guidance 유행성감기바이러스핵산진단제등록신청자료가이드라인 247 중국 Guidance 유행성감기바이러스항원진단제등록신청자료가이드라인 248 중국 Guidance 핵산증폭측정 (PCR) 시약등록기술심사가이드라인 249 중국 YYT1182 핵산증폭측정시약 ( 키트 ) Nucleic acids amplification test reagents(kits) 250 중국 Guidance 발광면역측정시약등록기술심사가이드라인 251 중국 YYT1181 252 생체적합성평가를위한본질적동등성 (SE) 평가 253 스텐트관련규격및가이드라인 254 스텐트관련규격및가이드라인 255 스텐트관련규격및가이드라인 256 의료기기사후관리 ( 리콜, 추적관리등 ) 257 의료기기사후관리 ( 리콜, 추적관리등 ) 258 의료기기사후관리 ( 리콜, 추적관리등 ) 259 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 260 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 261 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 면역조직화학시약키트 (Immunohistochemistry kit) 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] draft guidance. 시판전신고 [510(k)] 에서의본질적동등성평가 Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents 금속팽창성담관용스텐트의시판전신고 (510(k)) 내용 Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses 식도및기관보철물의시판전신고 (510(k)) 내용 Guidance Document for Testing Biodegradable Polymer Implant Devices 생분해성고분자이식용의료기기의시험 Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff Medical Device Tracking; Guidance for Industry and FDA Staff 의료기기추적관리산업계및미 FDA 직원을위한지침서 Draft Guidance for Industry and Food and Drug Administration Staff - Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act 산업계및 U.S. FDA 직원을위한지침서초안 522항에따른시판후감시의처리절차 Draft Guidance for Industry, User Facilities and FDA Staff: emdr - Electronic Medical Device Reporting 산업계, 병원, 사용자및 U.S. FDA 직원을위한지침서초안 Medical Device Reporting - Remedial Action Exemption; Guidance for FDA and Industry 의료기기부작용보고 시정조치면제대상 : 산업계및 U.S. FDA를위한지침서 MEDWATCH Medical Device Reporting Code Instructions MEDWATCH 의료기기부작용보고코드지침서
262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 전자의료기기사고보고시스템 (emdr, MDR, MEDW ATCH 등 ) 의료기기제조업체 요구사항 의료기기제조업체 요구사항 RTA 요구사항 RTA 요구사항 RTA 요구사항 의료기기라벨링 의료기기라벨링 의료기기라벨링 의료기기라벨링 281 GHTF/AHWG-UDI/N2R3 282 GHTF/SG2/N54R8 283 GHTF/SG3/N99-10 Medical Device Reporting - Alternative Summary Reporting (ASR) Program 의료기기부작용보고 - 대체요약보고 (ASR) 프로그램 Medical Device Reporting: An Overview 의료기기부작용보고 (Medical device reporting) 의개요 Medical Device Reporting for Manufacturers 제조업체의의료기기부작용보고 (MDR) Design Control Guidance For Medical Device Manufacturers 의료기기제조업체요구사항 Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007 산업계및 U.S. FDA 직원을위한지침서 2007 년 FDA 개정법에의한의료기기업체등록및품목등록요구사항의이행 Refuse to Accept Policy for 510(k)s Guidance for Industry and FDA Staff 시판전신고 ((510(k)) 에대한접수거부 (RTA) 정책 : 산업계및 U.S. FDA 심사원을위한지침서 Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy 의료기기 방사선보건센터의의료기기적용면제 (IDE) 의접수거부정책 Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy 의료기기 방사선보건센터의시판전신고 (510(K)) 접수거부정책 Device Labeling Guidance #G91-1 (blue book memo) 의료기기표시기재사항지침서 #G91-1 Unique Device Identification 의료기기고유식별코드 Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling 산업계및 U.S. FDA를위한지침서전자제품표시기재사항에 URL 추가 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile 산업계및 U.S. FDA 를위한지침서초안 멸균 표시기재가된의료기기에대한시판전신고 (510(k)) 제출문서의제출및심 사 Data Monitoring Committees, Establishment and Operation of Clinical Trial, Guidance for Clinical Trial Sponsors 의뢰자를위한데이터모니터링위원회의구성및운영 Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff Commercially Distributed 산업계및 U.S. FDA 직원을위한지침서 : 시장에서유통되고있는화학물질분석특이시약 (ASR) 에대해자주묻는질문 Humanitarian Device Exemption (HDE) Regulation: Questions and Answers; Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff HDE 면제권자, 심사위원회 (IRB), 자및 U.S. FDA 직원등을위한지침서 Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff 의료기기업계및 U.S. FDA 직원을위한지침서인도주의적사용목적의의료기기 (HUD) 지정 IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed IRB, 자및의뢰자를위한지침서 : 시험자의자격, 시험기관의적합성및 IND/IDE 의필요성확인을위한심사에 대한 IRB의책임 Electronic Source Data in Clinical Investigations 산업계를위한지침서에서입수한전자근거자료 Considerations When Transferring Clinical Investigation Oversight to Another IRB IRBs, 자및의뢰자를위한지침서 : 다른 IRB에감독업무이전시고려사항 Unique Device Identification (UDI) System for Medical Devices 의료기기 UDI 시스템 Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices 의료기기부작용보고 Quality Management Systems - Process Validation Guidance 의료기기공정밸리데이션 284 ASTM-F 748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices 285 ASTM-F 2475 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials 286 ASTM-F 1983 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications 287 ASTM-F 1877 Standard Practice for Characterization of Particles 288 ASTM-F 619 Standard Practice for Extraction of Medical Plastics 289 ASTM-F 1828 Standard Specification for Ureteral Stents 290 ASTM-F 2743 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems 291 ASTM-F 2606 Standard Guide for Three-point Bending of Balloon Expandable Vascular Stents and Stent Systems 292 ASTM-F 2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents 293 OECD 120 294 USP <661> 295 USP <381> 296 USP<1031> 297 IEC 60300-3-9 Solution/Extraction Behaviour of Polymers in Water 물에서고분자용액 / 용출형태 Containers - Plastics 플라스틱제의약품용용기 ELASTOMERIC CLOSURES FOR INJECTIONS 주사용탄성마개 THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS 의약품용기, 의료기기및이식형의료기기에사용되는재료의생체적합성 Dependability management- Part 3:Application guide-section 9:Risk analysis of technological systems 298 CEI IEC 62471 Photobiological safety of lamps and lamp systems 299 IEC TR 60825-8 Safety of laser products Part 8: Guidelines for the safe use of laser beams on humans 300 ISO 10555-1 Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements 301 ISO 10555-3 302 ISO 10555-4 303 ISO 10555-5 304 ISO 15197 Intravascular catheters Sterile and single-use catheters Part 3: Central venous catheters Intravascular catheters Sterile and single-use catheters Part 4: Balloon dilatation catheters Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 305 ISO 7405 Dentistry Evaluation of biocompatibility of medical devices used in dentistry 306 ISO/IEC GUIDE 51:1999 Safety aspects Guidelines for their inclusion in standards 307 ISO/IEC GUIDE 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
308 ISO/TR 24971 Medical devices Guidance on the application of ISO 14971 309 ISO 8536-9 Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipment 310 ISO 8600-1 Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirements 311 ISO 8600-2 Optics and optical instruments Medical endoscopes and endoscopic accessories Part 2: Particular requirements for rigid bronchoscopes 312 ISO 8600-3 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics 313 ISO 8600-4 Endoscopes Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion 314 ISO 8600-5 Optics and photonics Medical endoscopes and endotherapy devices Part 5: Determination of optical resolution of rigid endoscopes with optics 315 ISO 8600-6 Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary 316 ISO 10079-3 Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure source 317 ISO/IEEE 11073-10406 Health informatics Personal health device communication Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) 318 ISO/IEEE Health informatics Personal health device communication 11073-10417 Part 10417: Device specialization: Glucose meter 319 ISO/IEEE Health informatics Personal health device communication FDIS 11073-10407 Part 10407: Device specialization Blood pressure monitor 320 ISO/IEEE Health informatics Point-of-care medical device communication FDIS 11073-10415 Part 10415: Device specialization Weighing scale 321 ISO/IEEE Health informatics Personal health device communication FDIS 11073-10404 Part 10404: Device specialization Pulse oximeter 322 ISO/IEEE Health informatics Point-of-care medical device communication FDIS 11073-10408 Part 10408: Device specialization Thermometer 323 ISO/IEEE Health informatics Personal health device communication 11073-10420 Part 10420: Device specialization Body composition analyzer 324 ISO 13781 Poly(L-lactide) resins and fabricated forms for surgical implants - In vitro degradation testing 325 ISO 15814 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing 326 ISO 5361 Anaesthetic and respiratory equipment Tracheal tubes and connectors 327 ISO 5366-1 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1:Tubes and connectors for use in adults 328 ISO 5366-3 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes 329 ISO 16628 Tracheobronchial tubes Sizing and marking 330 ISO 25539-1 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses 331 ISO 25539-2 Cardiovascular implants Endovascular devices Part 2: Vascular stents 332 ISO 11810 Optics and optical instruments -- Lasers and laser-related equipment -- Test method for the laser-resistance of surgical drapes and/or patient-protective covers 333 ISO 11810-1 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration 334 ISO 11810-2 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition 335 ISO 11990 Optics and optical instruments -- Lasers and laser-related equipment -- Determination of laser resistance of tracheal tube shafts 336 ISO 11990-1 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1:Tracheal tube shaft 337 ISO 11990-2 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs 338 ISO 11146 Lasers and laser-related equipment -- Test methods for laser beam parameters -- Beam widths, divergence angle and beam propagation factor 339 ISO 11146-1 Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 1: Stigmatic and simple astigmatic beams 340 ISO 11146-2 Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 2: General astigmatic beams 341 ISO 11554 Optics and photonics Lasers and laser-related equipment Test methods for laser beam power, energy and temporal characteristics 342 ISO 11145 Optics and photonics Lasers and laser-related equipment Vocabulary and symbols 343 ISO 14408 Tracheal tubes designed for laser surgery Requirements for marking and accompanying information 344 ISO 16284 Ophthalmic optics Information interchange for ophthalmic optical equipment 345 ISO 13695 Optics and photonics Lasers and laser-related equipment Test methods for the spectral characteristics of lasers 346 ISO 13694 Optics and optical instruments Lasers and laser-related equipment Test methods for laser beam power [energy] density distribution 347 ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants 348 ISO/TR 11175 Dental implants - Guidelines for developing dental implants 349 ISO/TS 22911 Dentistry Preclinical evaluation of dental implant systems Animal test methods 350 ISO 10451 Dentistry Contents of technical file for dental implant systems 351 ISO 13683 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities 352 ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 353 ISO/TS 17665-2 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1 354 DIN 6868-3 Image quality assurance in diagnostic X-ray departments Part 3: Constancy testing in direct radiography 355 DIN 6868-5 Image quality assurance in diagnostic X-ray departments Part 5: RöV constancy testing of dental radiographic equipment 356 DIN 6868-7 Image quality assurance in X ray departments Part 7: Constancy testing of mammographic X ray equipment
357 DIN EN 1618 Catheters other than intravascular catheters Test methods for common properties English version of DIN EN 1618 Medical electrical equipment 358 BS EN 60601-2-22 diagnostic laser equipment 359 BS EN 1641 Dentistry Medical devices for dentistry Materials Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and 360 EN 1642 Dentistry Medical devices for dentistry Dental implants 361 EN 13612 Performance evaluation of in vitro diagnostic medical devices 362 EN13640 Stability testing of in vitro diagnostic reagents 363 MEDDEV 2.12_2 364 AS_NZS_4173 365 AS_NLS_3200_2-22 366 중국 YY/T 0111 367 중국 YY 0767 368 중국 YY 0448 369 중국 YY/T 0010 370 중국 YY/T 0268 371 중국 YY 0341 372 중국 YY/T 0340 373 중국 YY 0673 374 GB/T 14233.1 post market clinical follow up 판매후임상적사후관리가이드라인 Ophthalmic optics -- Information interchange for ophthalmic optical equipment 의료용레이저의안전사용지침서 Approval and test specification - Medical electrical equipment Particular requirements for safety - Diagnostic and therapeutic laser equipment 진단및치료용레이저장비의안전에대한개별요구사항초음파도플러탐촉자기술요구사항및시험방법 Technical requirements and test methods for ultrasonic Doppler transducer 초음파컬러플로우영상시스템 Ultrasonic Colour Flow Imaging Systems 초음파도플러태아용심박측정기 Ultrasonic Doppler fetal heartbeat detector 구강 X-선장치개별기술조건 Particular specifications for X-ray unit for oral cavity 치과학구강의료기기생물학적평가제1부분 : 평가와시험 Dentistry Biological evaluation of medical devices used in dentistry Part 1 : Evaluation and test 골접합용무원외과용금속이식재일반기술조건 General technological requirements for non-active Metallic surgical implants for osteosynthesis 외과이식재기본원칙 Implants for surgery Fundamental principles (ISO/TR 14283: 2004, IDT) 검안용굴절력측정기 Opthalmic instruments Eye refractometers 의료용수액 수혈 주입장치검사방법제 1부분 : 화학분석방법 375 중국 Guidance 시린지펌프제품등록기술심사가이던스 376 중국 Guidance 일회용진공채혈관제품등록기술심사가이드라인 377 중국 Guidance 시린지펌프제품등록기술심사가이던스 378 중국 YY/T 1192 379 중국 YY/T 1175 380 중국 YY/T 1162 381 중국 YY/T 1160 Test methods for infusion, transfusion, injection equipments for medical use Part 1 : Chemical analysis methods 인간융모성성선자극호르몬 (HCG) 정량검출시약 ( 키트 ) ( 화학발광면역분석법 ) Human chorionic gonadotropin(hcg) quantitative detection reagent(kit) (chemiluminescent immunoassay) 종양표지물질정량검출시약 ( 키트 ) 화학발광면역분석법 Quantitative detection reagent (Kit) for tumor markers Chemiluminescent Immunoassay 알파태아단백 (AFP) 정량검출시약 ( 키트 )( 화학발광면역분석법 ) Alpha-fetoprotein quantitative detection reagent(kit)(chemiluminescent Immunoassay) 발암배아성항원 (CEA) 정량검출시약 ( 키트 )( 화학발광면역분석법 ) Carcinoembryonic Antigen Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay) 382 중국 Guidance 올세라믹의치용산화지르코늄세라믹블록제품등록기술심사가이드라인 383 중국 YY0716 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 의료기기전자등록프로그램 모바일어플의료기기 의료기기고유식별코드 GLP 사이버보안 인허가문서검토 의료기기품목코드 분자진단기능을가진의료기기 시판전승인등의수수료등 의료기기의소아사용 혈관내스텐트및전달시스템 10993 적용 의료기기부작용보고 라텍스소재의료기기 시판전신고등의수수료등 JIS T 0701 소프트콘택트렌즈 치과세라믹 Dental-Ceramic Guidance for Industry and Food and Drug Administration Staff - ecopy Program for Medical Device Submissions 의료기기접수를위한 ecopy 프로그램지침서 Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff 모바일의료용애플리케이션 Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry 국제의료기기고유식별데이터베이스 (GUDID) The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff 시판전의료기기허가제출서에서비관리기준적용가능성 : 질의및응답 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff 의료기기사이버보안 Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices 의료기기의시판전제출문서에대한우선심사 Medical Device Classification Product Codes- Guidance for Industry and Food and Drug Administration Staff 의료기기제품분류코드 Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff 복합기능을갖는분자진단용기기 Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications 시판전승인신청과의료기기 - 생물학적제제허가신청을위한심사료및환불지침서 Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act 미연방식품의약품및화장품법 515A항에명시된의료기기의소아과사용에관한정보의제공 Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Draft Guidance for Industry and Food and Drug Administration Staff 혈관내스텐트및관련전달시스템에대한비임상공학시험과권장기재사항의선택적개정 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" - Draft Guidance for Industry and Food and Drug Administration Staff 국제표준 ISO-10993 의료기기의생물학적평가제1부 : 평가및시험 의이용 Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers 의료기기부작용보고 Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex 라텍스를사용하지않는의료기기에대한표시기재사항 Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions 시판전신고서 (510(k)) 의제출을위한수익자부담금과환급コンタクトレンズの用語及び材料の分類方法 Contact lenses -- Vocabulary and classification system 콘택트렌즈의용어및재료의분류방법
400 401 402 403 404 405 406 407 JIS T 0401 스텐트 JIS T 3269 기관용튜브 카테터 GOST IEC 60601-2-43 디지털엑스선촬영장치 GOST R 53939 시력보정용안경렌즈 GOST R 54328 치과용임플란트 ABNT NBR IEC 60601-2-5 초음파영상진단장치 ABNT NBR IEC 60601-2-43 디지털엑스선촬영장치 ABNT NBR IEC 60601-2-49 환자감시장치 408 GHTF/SG3/N15R8 409 GHTF/SG1/N68 410 GHTF/SG3/N18:2010 胆すい ( 膵 ) 管用ステント及びドレナージカテーテル Stents and drainage catheters for biliary and pancreatic ducts 스텐트그래프트의기계적시험방법胆すい ( 膵 ) 管用ステント及びドレナージカテーテル Stents and drainage catheters for biliary and pancreatic ducts 담즙 ( 췌장 ) 관용스텐트및 drainage 카테터 Изделия медицинские электрические. Част ь 2-43. Частные требования безопасности к рентге новским аппарата м для интервенционных процедур ( 영문 : Medical electrical equipment. Part 2-43.Particular requirements for the safety of X-ray equipment for interventional procedures) 의료용전기기기 2-43. 중재절차 X-선장비의안전에대한특정요구사항 Оптика офтальмологическая. Линзы очков ые полуготовые. Общие технические требования. Методы испытани ( 영문 : Ophthalmic optics. Semi-finished spectacle lens blanks. General specifications. Test methods) 안과광학. 렌즈 - 일반기술요구사항. 시험방법 Оптика офтальмологическая. Линзы очков ые полуготовые. Общие технические требования. Методы испытани ( 영문 : Dentistry. Preclinical evaluation of dental implant systems. Animal test methods) 안과광학. 렌즈 - 일반기술요구사항. 시험방법 Equipamento eletromédico Parte 2-5: Requisitos particulares para a segurança básica e desempenho essencial dos equipamentos de fisioterapia por ultrassom ( 영문 : Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment ) 의료용전기기기 2-5 기본안전및초음파물리치료장비의필수성능에대한개별요구사항 Equipamento eletromédico Parte 2-43: Requisitos particulares para a segurança básica e desempenho essencial dos equipamentos de raios X para procedimentos intervencionistas ( 영문 : Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures ) 의료용전기기기 2-43 기본안전및중재절차를위한 X-선장비의필수성능에대한개별요구사항 Equipamento eletromédico Parte 2-49: Prescrições particulares para segurança de equipamento para monitorização multiparamétrica de paciente ( 영문 : Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment) 의료용전기기기 2-49 : 다목적환자모니터링을위한안전장비에대한개별요구사항 Implementation of risk management principles and activities within a Quality Management System 품질관리시스템에서위험관리원칙및활동의 Essential Principles of Safety and Performance of Medical Devices 의료기기의안전성및성능에관한기본원칙 Quality management system Medical Devices Guidance on corrective action and preventive action and related QMS processes 품질관리시스템 - 의료기기 - 시정조치, 예방조치, QMS 프로세스관련가이드 411 ASTM-F 1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages1 412 ASTM- F 1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration 413 ASTM- D 4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing 414 ASTM-D 882-02 Standard Test Method for Tensile Properties of Thin Plastic Sheeting 415 ASTM-F 2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 416 ASTM-F 2902 Standard Guide for Assessment of Absorbable Polymeric Implants 417 ASTM-F 1635 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants 418 ASTM-F 2502 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants 419 ASTM-F 3036 Standard Guide for Testing Absorbable Stents 420 ASTM-F 2942 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents 421 ASTM-F 2914 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices 422 ASTM-D 4464 Standard Test Method for Particle Size Distribution of Catalytic Materials by Laser Light Scattering 423 AAMI 11138-4 424 ANSI/AAMI ST55 425 AAPM Report no.125 426 AAPM Report no. 74 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 헬스케어제품의멸균 -습열- 제2부 : ISO 17665-1의적용에관한지침 Table-top steam sterilizers 의료용소형증기멸균기 Functionally and operation of fluoroscopic automatic brightness control automatic dose rate control logic in modern cardiovascular and interventional angiography systems 최신중재적혈관조영촬영장치에서자동휘도조절 / 자동선량률조절기능에관한가이드 in direct radiography Quality control in diagnostic radiology 진단방사선학의품질관리에관한가이드 427 JESRA X-0067*B 감마카메라의성능및보수점검기준 428 JESRA X-0071*B 감마카메라의안전성및보수점검기준 429 CLSI EP5:A2 Checklist for audit of notidied bosy s review of clinical data/clinical evaluation 정량적측정방법의정밀도성능평가 430 IEC62127-1Ed.1.1b Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz 431 IEC/TR 62799 Ed. 1.0 en Modelsforevaluationofthermalhazardinmedicaldiagnosticultrasonicfields 432 IEC 61689 Ed. 3.0 b Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz 433 IEC 60601-2-62 Ed. 1.0 b Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment 434 IEC 62555 ed1.0 (2013-11) Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems 435 IEC 60601-2-68Ed. 1.0 b Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment 436 IEC 60825-1 ed3.0 Safety of laser products - Part 1: Equipment classification and requirements 437 MEDDEV 2.2_4(2012) Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products 438 MEDDEV 2.14_1 rev.2(2012) GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues 439 MEDDEV 2.14_2 rev.1(2004) IVD GUIDANCE - Research Use Only products 440 MEDDEV 2.14_3 rev.1(2007) IVD GUIDANCES - Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices 441 ISO 23640:2011 Invitrodiagnosticmedicaldevices--Evaluationofstabilityofinvitrodiagnosticreagents 442 ISO 80601-2-67:2014 - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment