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.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015— 63 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.
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015— 71 стр.
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016); German version EN ISO 80369-3:2016— 59 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 electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems— 96 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.
Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling— 22 стр.
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use— 22 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. Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients— 102 стр.
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation— 28 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 haemodialysis, haemodiafiltration and haemofiltration equipment— 72 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment— 58 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV— 68 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 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010) (english version)
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2012) (english 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)
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (IEC 60601-1-6:2010) (english version)
Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006 + A1:2012) (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)
