Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems— 48 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012); German version EN ISO 11608-1:2012— 49 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015— 52 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.
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016); English version EN ISO 11073-10419:2016— 146 стр.
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor. 1:2016); English version EN ISO 11073-20601:2016— 277 стр.
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards— 50 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.
Application of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls— 56 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. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy— 82 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 the development of physiologic closed-loop controllers— 44 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.
Safety requirements for electrical equipment for measurement, control, and laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials— 42 стр.
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor (ISO/IEEE 11073-10418:2014); English version EN ISO 11073-10418:2014— 73 стр.
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) (ISO/IEEE 11073-10424:2016); English version EN ISO 11073-10424:2016— 131 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.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems— 62 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 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) (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 2-13: 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)
Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)
