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의료기기 인증 관련 IEC 국제규격 목록 및 시험안내
ADMIN  2011-05-23 16:06:52, 조회 : 878, 추천 : 92

의료기기 인증 관련 IEC 국제규격 목록 및 시험안내


IEC 국제규격(의료기기 분야)

IEC 60601-1 (1988-12) 의료기기 및 주변기기의료용 전원장치 Medical Electrical Equipment - General requirements
IEC 60601-1-1 (2000-12) 의료기기 시스템 Medical electrical systems
IEC 60601-1-2 (2004-11) 의료기기 EMC Electromagnetic compatibility
IEC 60601-1-3 (1994-07) X선기기 (X-ray Radiation)Radiation protection in diagnostic X-ray equipment
IEC 60601-1-4 (2000-04) 의료용 소프트웨어 의료기내 소프트웨어 Programmable electrical medical systems
IEC 60601-1-6 (2004-06) 소프트웨어-사용상의 착오 Usability
IEC 60601-1-8 (2003-08) 알람장치 Alarm Systems
IEC 60601-2-1 (1998-06) 방사선치료기 -전자가속기 Electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-2 (1998-09) 고주파수술기  High frequency surgical equipment
IEC 60601-2-3 (1991-06) 고주파 치료기 Short-wave therapy equipment
IEC 60601-2-4 (2002-08) 심실세동기 Cardiac defibrillators
IEC 60601-2-5 (2000-07) 초음파 치료기 Ultrasonic physiotherapy equipment
IEC 60601-2-6 (1984-01) 고주파 치료기 Microwave therapy equipment
IEC 60601-2-7 (1998-02) X선기기의 고압발생기 High-voltage generators of diagnostic X-ray generators
IEC 60601-2-8 (1999-04) X선치료기 Therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60601-2-9 (1996-10) 환자당량측정기 Patient contact dosimeters used in radiotherapy with electrically connected radiation detectors
IEC 60601-2-10 (1987-12) 저주파치료기 Nerve and muscle stimulators
IEC 60601-2-11 (1997-08) 방사선치료기 -감마선치료기 Gamma beam therapy equipment
IEC 60601-2-12 (2001-10) 산소호흡기 Lung ventilators - Critical care ventilators
IEC 60601-2-13 (2003-05) 마취기 Anesthetic systems
IEC 60601-2-16 (1998-02) 신장투석기 Hemodialysis, hemodiafiltration and hemofiltration equipment
IEC 60601-2-17 (2004-01) 근접치료기 Automatically-controlled brachytherapy afterloading equipment
IEC 60601-2-18 (1996-08) 내시경 Endoscopic equipment
IEC 60601-2-19 (1990-12) 보육기 Baby incubators
IEC 60601-2-20 (1990-12) 보육기 Transport incubators
IEC 60601-2-21 (1994-02) 유아용 온열장치 Infant radiant warmers
IEC 60601-2-22 (1995-11) 진단용 레이저기기 레이저 치료기 Diagnostic and therapeutic laser equipment
IEC 60601-2-23 (1999-12) CO2 감시장치 Transcutaneous partial pressure monitoring equipment
IEC 60601-2-24 (1998-02) 수액 펌프 Infusion pumps and controllers
IEC 60601-2-25 (1993-03) 심전계 Electrocardiographs
IEC 60601-2-26 (2003-12) 뇌파계 Electroencephalographs
IEC 60601-2-27 (1994-04) 심전도 감시장치 Electrocardiographic monitoring equipment
IEC 60601-2-28 (1993-03) 진단용X선 기기 X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-29 (1999-01) 방사선치료시뮬레이터 Radiotherapy simulators
IEC 60601-2-30 (1999-12) 혈압 감시 장치 Automatic cycling non-invasive blood pressure monitoring equipment
IEC 60601-2-31 (1994-10) 페이스메이커 External cardiac pacemakers with internal power source
IEC 60601-2-32 (1994-03) X선기기의 주변기기 Associated equipment of X-ray equipment
IEC 60601-2-33 (2002-05) 자기공명(MR)  영상진단장치 Magnetic resonance equipment for medical diagnosis
IEC 60601-2-34 (2000-10) 침습형 혈압 감시장치 Invasive blood pressure monitoring equipment
IEC 60601-2-35 (1996-11) 매트리스 (히터) Blankets, pads and mattresses intended for heating in medical use
IEC 60601-2-36 (1997-03) 쇄석기 Equipment for extracorporeally induced lithotripsy
IEC 60601-2-37 (2004-10) 초음파진단기 Ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-38 (1996-10) 병원용 침대 Electrically operated hospital beds
IEC 60601-2-39 (2003-12) 복막투석기 Peritoneal dialysis equipment
IEC 60601-2-40 (1998-02) 근전도 및 유발반응 기기 Electromyographs and evoked response equipment
IEC 60601-2-41 (2000-02) 수술등, 검진등 Surgical luminaries and luminaries for diagnosis
IEC 60601-2-43 (2000-06) X선기기 (interventional use) X-ray equipment for interventional procedures
IEC 60601-2-44 (2002-11) X-ray CT X-ray equipment for computed tomography
IEC 60601-2-45 (2001-05) 유방검사용X선기기 Mammographic X-ray equipment and mammographic stereotactic devices
IEC 60601-2-46 (1998-06) 수술대 Operating tables
IEC 60601-2-47 (2001-07) 홀터심전계 Ambulatory electrocardiographic systems
IEC 60601-2-49 (2001-07) 환자감시장치 Multifunction patient monitoring equipment
IEC 60601-2-50 (2000-07) 유아용 황달치료기 Infant phototherapy equipment
IEC 60601-2-51 (2003-02) ECG 분석기 Recording and analyzing single channel and multichannel electrocardiographs
IEC 61010-1 (2001-02) 멸균기, 필름현상기 체외진단기기 Electrical equipment for measurement, control, and laboratory use - General requirements
IEC 61010-2-010 (2005-01) 오븐 치과용 장치 Laboratory equipment for the heating of materials
IEC 61010-2-020 (1992-09) 원심분리기 Laboratory centrifuges
IEC 61010-2-040 (2005-04) 멸균기, 소독기 Sterilizers and washer-disinfectors used to treat medical materials
IEC 61010-2-051 (2005-02) 믹서 Laboratory equipment for mixing and stirring
IEC 61010-2-061 (2005-03) 스펙트럼분석기 Laboratory atomic spectrometers with thermal atomization and ionization
IEC 61010-2-081 (2001-12) 의료용 검사 키트(kit) Automatic and semi-automatic laboratory equipment for analysis and other purposes
IEC 61010-2-101 (2002-01) 체외진단기기 In Vitro diagnostic (IVD) medical equipment
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