Compliance Engineering Nederland

Lijst van veel gebruikte normen

IEC General Standard: 

IEC 60601-1, Edition 3.1 (2012-11-14) + Corr.1 (2014-07-22) Ed. 3.1 = IEC 60601-1, Edition 3 (2005-12), Corr.1 (2006-12), Corr.2 (2007-12), IS1 (2008-04), IS2 (2009-01), Am.1 (2012-07), IS3 (2013-05) 

National Deviations: 

USA: ANSI/AAMI ES 60601-1:2005(R)2012 (11-2012) = ANSI/AAMI ES60601-1:2005 (02/05), + Amendment 1 

CANADA: CSA C22.2 No.60601-1:14 (2014) = CSA C22.2 No.60601-1:2008, + Amendment 1 

EUROPEAN UNION: EN 60601-1:2006 + A1:2013 (2013) + Amendment 11 (2011), + Amendment 12 (2014) 

IEC 60601-1-xx (Collaterals): 

60601-1-01: Safety Requirements for Medical Electrical Systems. Ed.2. (Now in base standard) 

60601-1-02: Electromagnetic Compatibility - Requirements and Tests. Ed.3 (2007-03), IS1 (2010-03), Ed. 4 (2014-02) 

60601-1-03: Gen. Requirements for Radiation Protection in Diagnostic X-ray Equipment. Ed.2. (2008-01), Am.1 (2013-04), Ed.2.1 (2013-04) 

60601-1-04: Programmable Electrical Medical Systems. (Now in base standard) 

60601-1-05: Image quality and dose for X-ray equipment (Cancelled) 

60601-1-06: Usability Ed.3. (2010-01), Am.1 (2013-10), Ed.3.1 (2013-10) - Requires IEC 62366 (Usability, Medical Devices) Ed.1 (2007-10) 

60601-1-07: General requirements for multiparameter patient monitoring equipment (Moved to IEC 60601-2-49). 

60601-1-08: Requirements/guidelines for alarms in Medical Electrical Equipment. Ed.2. (2006-10), Am.1 (2012-11); Ed.2.1 (2012-11) 

60601-1-09: Requirements for the reduction of environmental impacts. Ed.1. (2007-07), Ed.1.1 (2013-06) 

60601-1-10: Process requirements for the development of therapeutic closed-loop controllers Ed.1. (2007-11), Am.1 (2013-11), Ed.1.1 (2013-11) 

60601-1-11: Medical Electrical Equipment for Use in Home Care Applications. Ed.1. (2010-04), Corr.1 (2011-04), Ed.2 (2015-01) 

60601-1-12: ME and MES used in the emergency medical services environment. Ed.1. (2014-06) 


IEC 60601-2-xx, IEC/ISO 80601-2-xx (Particulars): 

60601-2-01: Medical Electron Accelerators in the Range 1 MeV to 50 MeV. Ed.3. (2009-10), Am.1/Ed.3.1 (2014-07), Ed.4 (Project 2016-10) 

60601-2-02: High Frequency Surgical Equipment. Ed.5. (2009-02), Corr.1 (2014-02), Ed.6 (Project 2017-06) 

60601-2-03: Short-Wave Therapy Equipment. Ed.3 (2012-04), Am.1 (Project 2016-05) 

60601-2-04: Cardiac Defibrillators, Defibrillator-Monitors. Ed.3. (2010-12) 

60601-2-05: Ultrasonic Therapy Equipment. Ed.3. (2009-07) 

60601-2-06: Microwave Therapy Equipment.. Ed.2 (2012-04), Am.1 (Project 2016-05) 

60601-2-07: High Voltage Generators of Diagnostic X-ray Generators. (Incorporated into IEC 60601-2-54) 

60601-2-08: Therapeutic X-ray Equipment in the Range 10 kV to 1 MV. Ed.2. (2010-11), Am.1 (Project 2015-04) 

60601-2-09: Patient Contact Dosimeters used in Radiotherapy with Electrically Connected Radiation Detectors. (Cancelled) 

60601-2-10: Nerve and Muscle Stimulators. Ed.2. (2012-06), Am.1 (Project 2016-05) 

60601-2-11: Gamma Beam Therapy Equipment. Ed.3. (2013-01) 

80601-2-12 (ISO): Critical Care Ventilators. Ed.1. (2011-05) 

80601-2-13 (ISO): Anesthetic Workstation. Ed.1 (2011-08), Am.1 (Project) 

60601-2-14: Electroconvulsive Therapy Equipment (1989-03) (Withdrawn) 

60601-2-15: Capacitor Discharge X-ray Generators (1988-12) (Withdrawn) 

60601-2-16: Hemodialysis Equipment. Ed.3. (2008-04), Corr.1. (2008-10); Ed.4. (2012-03) 

60601-2-17: Automatically-controlled brachytherapy afterloading equipment. Ed.3. (2013-11) 

60601-2-18: Endoscopic Equipment. Ed.3. (2009-08) 

60601-2-19: Infant Incubators. Ed.2. (2009-02), Corr.1 (2012-02), Am.1 (Project 2016-05) 

60601-2-20: Infant transport incubators. Ed.2. (2009-02), Corr.1 (2012-02), Corr.2 (2013-02), Am.1 (Project 2016-05) 

60601-2-21: Infant Radiant Warmers. Ed.2. (2009-02), Corr.1 (2013-02), Am.1 (Project 2016-05) 

60601-2-22: Surgical, cosmetic, therapeutic, and diagnostic laser equipment. Ed.3. (2007-05), Am.1. (2012-10), Ed.3.1 (2012-10) 

60601-2-23: Transcutaneous Partial Pressure Monitoring Equipment. Ed.3. (2011-02) 

60601-2-24: Infusion Pumps and Controllers. Ed.2 (2012-10) 

60601-2-25: Electrocardiographs. Ed.2. (2011-10) 

60601-2-26: Electroencephalographs. Ed.3. (2012-05) 

60601-2-27: Electrocardiographic Monitoring Equipment. Ed.3. (2011-03), Corr.1 (2012-05) 

60601-2-28: X-ray tube assemblies for medical diagnosis. Ed.2. (2010-03) 

60601-2-29: Radiotherapy Stimulators. Ed. 3. (2008-06) 

80601-2-30 (IEC/ISO): Automated non-invasive sphygmomanometers. Ed.1 (2009-01), Corr.1 (2010-01), Am.1 (2013-07), Ed.1.1 (2013-07) 60601-2-31: External Cardiac Pacemakers with Internal Power Source. Ed.2. (2008-03), Am.1. (2011-06), Ed.2.1. (2011-09) 

60601-2-32: Associated Equipment of X-ray Equipment. (Incorporated into IEC 60601-2-54) 

60601-2-33: Magnetic Resonance Equipment for Medical Diagnosis. Ed.3 (2010-03), Corr.1 (2012-03), Am.1 (2013-04), Ed. 3.1 (2013-04), Am.2 (Project 2015-06) 

60601-2-34: Invasive Blood Pressure Monitoring Equipment. Ed.3 (2011-05) 

80601-2-35 (IEC/ISO): Heating devices using blankets, pads, mattresses... Ed.2. (2009-10), Corr.1 (2012-03), Corr.2 (Project), Am.1 (Project 2016-05) 

60601-2-36: Extracorporeally Induced Lithotripsy. Ed.2. (2014-04) 

60601-2-37: Ultrasonic Diagnostic and Monitoring Equipment. Ed.2. (2007-08), Am.1 (Project 2015-06) 

60601-2-38: Electrically Operated Hospital Beds. (Moved to IEC 60601-2-52) 

60601-2-39: Peritoneal Dialysis Equipment. Ed.2. (2007-11) 

60601-2-40: Electromyographs and Evoked Response Equipment. Ed.2. (Project 2015-12) 

60601-2-41: Surgical Luminaires and Luminaires for Diagnosis. Ed.2 (2009-08), Am.1 (2013-10), Ed.2.1 (2013-10) 

60601-2-42: Automatic or Advisory External Defibrillators (Incorporated into IEC 60601-2-4). 

60601-2-43: X-ray Equipment for Interventional Procedures. Ed.2. (2010-03) 

60601-2-44: X-ray Equipment for Computed Tomography. Ed.3. (2009-02), Corr.1. (2010-05), Am.1. (2012-08), Ed.3.1 (2012-09) 

60601-2-45: Mammographic X-ray equipment and mammomagraphic stereotactic devices. Ed.3. (2011-02), Am.1 (Project 2015-02) 

60601-2-46: Operating Tables. Ed.2. (2010-12), Ed.3 (Project 2017-02) 

60601-2-47: Ambulatory Electrocardiographic Monitors [Holter Monitors]. Ed.2. (2012-02) 

60601-2-48: Canceled 

60601-2-49: Multiparameter Patient Monitoring Equipment. Ed.2. (2011-02) 

60601-2-50: Infant phototherapy equipment. Ed.2. (2009-03), Corr.1. (2010-08), Am.1 (Project 2016-05) 

60601-2-51: Recording and analyzing single and Multichannel electrocardiographs. (Incorporated into IEC 60601-2-25) 

60601-2-52: Safety of Medical Beds (replaces IEC 60601-2-38). Ed.1. (2009-12), Corr1. (2010-09), Am.1 (Project 2015-03) 

60601-2-53: Computer Assisted Electrocardiography Communication Protocol. Ed.1 (Canceled) 

60601-2-54: X-ray equipment for radiography and radioscopy. Ed.1. (2009-06), Corr.1. (2010-03), Corr.2. (2011-06), Am.1 (Project 2015-03) 

80601-2-55 (ISO): Respiratory gas monitors. Ed.1. (2011-12), Ed.2 (Project) 

80601-2-56 (ISO): Clinical thermometers for body temperature measurement. Ed.1. (2009-012), Ed.2 (Project) 60601-2-57: Non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. Ed.1. (2011-01) 

80601-2-58 (IEC/ISO): Lens removal devices and vitrectomy devices for ophthalmic surgery. Ed.1 (2008-10), Ed.2 (2014-09) 80601-2-59 (IEC/ISO): Screening thermographs for human febrile temperature screening, Ed.1 (2008-10), Corr.1. (2009-04) 

80601-2-60 (IEC/ISO): Dental equipment. Ed.1. (2012-02) 

80601-2-61 (ISO): Pulse Oximeter equipment. Ed.1. (2011-03), Ed.2 (Project 2016-09) 

60601-2-62: High intensity therapeutic ultrasound (HITU) systems. Ed.1. (2013-07) 60601-2-63: Dental X-ray equipment. Ed.1. (2012-09) 60601-2-64: Medical light ion accelerators in the range 10 MeV/n to 500 MeV/n. Ed.1 (2014-09) 

60601-2-65: Dental intra-oral X-ray equipment. Ed.1. (2012-09) 

60601-2-66: Hearing Instruments and Hearing Systems. Ed.1. (2012-10), Ed.2 (Project 2015-12) 

80601-2-67 (ISO): Oxygen-conserving equipment. Ed.1. (2014-05) 

60601-2-68: X-ray Image Guided Radiotherapy Equipment (electron accelerators, ion beam therapy, radionuclide beam). Ed.1. (2014-09) 

80601-2-69 (ISO): Oxygen concentrator equipment. Ed.1. (2014-05) 

80601-2-70 (ISO): Sleep apnea breathing therapy equipment. Ed.1. (2015-01) 

80601-2-71 (IEC/ISO): Functional Oximeter equipment. Ed.1. (Project 2015-08) 

80601-2-72 (ISO): Home healthcare environment ventilators for ventilator-dependent patients. (from ISO 10651-2:2004) Ed.1. (Project 2015-02) 

80601-2-73 (ISO): Medical supply units (head walls). Ed.1. (Project) 

80601-2-74 (ISO): Respiratory humidifying equipment. Ed.1. (Project 2016-04)