형식시험
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 |