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UL은IEC 60601-1, IEC 60601-2-xx 및 IEC 61010-1, IEC 61010-2-xx 등의 국제규격과 기타 의료기기에 관련된 규격을 적용하여 Test를 서비스하고 있습니다. 이 승인서는 STR(Statement of Test Result)이며, Test report를 첨부하고 있습니다. 이는 사후에 각종 해외 인증이나 국제 입찰 혹은 바이어 제출용으로 활용할 수 있습니다. UL 마크와 함께 신청하시면 보다 저렴한 비용으로 진행하실 수 있습니다.

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