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This document specifies short-range wireless active communication between two active IoT/telematic hardware items, such as a gateway device and/or a sensor. NOTE            Active hardware item in this document refers to devices and sensors, which have capacity to record and transmit measurements, i.e. data, without external activation through extra accessories, e.g. readers or scanners. The…

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to…

This document specifies: —     the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments; —     the general categorization of gas pathways based on the nature and duration…

This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the…

This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical…

This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the…

This document applies to nuclear power plants with water cooled reactors. For other nuclear facilities check the applicability of the document in advance, before it might be applied correspondingly. This document specifies the requirements for the earthquake safety of components. The operation-specific safety-related requirements for each component, e.g. load-bearing capacity (stability),…

IEC 80601-2-58:2024 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY…

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and…

This document defines an inventory of building blocks conceptually associated with different types of assessments of information and communication technology (ICT) trustworthiness. These assessments apply to areas such as governance, risk management, security evaluation, secure development lifecycle (SDL), supply chain integrity and privacy. This document also defines an ontology that organizes…