Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 26 стр.
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015); German version EN ISO 80601-2-72:2015— 117 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2009— 46 стр.
Medical electrical equipment. 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— 68 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 стр.
Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements— 98 стр.
Medical electrical equipment. 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— 60 стр.
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version EN ISO 80601-2-56:2012— 63 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis— 130 стр.
Medical electrical equipment. Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients— 102 стр.
BS EN ISO 80601-2-12. Medical electrical equipment. Part 2-12. Particular requirements for basic safety and essential performance of critical care ventilators— 132 стр.
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment— 56 стр.
Medical electrical equipment. 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— 68 стр.
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers— 44 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment— 42 стр.
Medical electrical equipment. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency— 98 стр.
Medical electrical equipment. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment— 86 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment— 72 стр.
BS EN ISO 80601-2-13. Medical electrical equipment. Part 2-13. Particular requirements for basic safety and essential performance of an anaesthetic workstation— 139 стр.
BS EN ISO 80601-2-85. Medical electrical equipment. Part 2-85. Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)— 113 стр.
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medical electrical equipment - 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 (IEC 60601-1-11:2010) (english version)
Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2012) (english version)
Medical electrical equipment -- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Corr.: 2010-01 + A1:2013) (english version)
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011) (english version)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) (english version)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/IEC 80601-2-12:2011 + Cor.:2011) (english version)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011 + Amd 1:2015 + Amd 2:2018) (consolidated version)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, corrected version 2018-02)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd 1:2018) (consolidated version)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
Medical electrical equipment -- Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (IEC 60601-1-12:2014) (english version)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
Medical electrical equipment -- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010 + COR1:2012 + A1:2013 + A2:2015 + COR2:2016) (english version)
Medical electrical equipment -- 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 (IEC 60601-1-11:2015) (english version)
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013) (english version)
Medical electrical equipment -- Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012) (english version)
