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Anaesthetic and respiratory equipment
  • ISO 7376-2020 pdf download.Anaesthetic and respiratory equipment一Laryngoscopes for tracheal intubation. This document, which is device-specific, specifies requirements for laryngoscopes with non-flexibi blades, with internal battery-operated power sources, used for illuminating the larynx dunn intubation. It also specifies critical dimensions for those handles and laryngoscope blades wit interchangeable hook-on fittings. It is not applicable to the following: — flexible laryngoscopes; — laryngoscopes designed for surgery; — laryngoscopes powered from mains electricity supply; — laryngoscopes connected by light-transmitting cables to external light sources; — video laryngoscopes designed to work with an external, integral or attached video system. 2 Normative references The following documents are referred to in the text in such a way that some or all of their conter constitutes requirements of this document. For dated references, only the edition cited applies. Fc undated references, the latest edition of the referenced document (including any amendments) applie ISO 4135, Anaesthetic and respiratory equipment — Vocabulary ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and relate equipment IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety an essential performance — Collateral Standard: Requirements for medical electrical equipment and medic electrical systems used in the emergency medical…

  • BS EN ISO 5364:2016 pdf download.Anaesthetic and respiratory equipment一Oropharyngeal airways (ISO 5364:2016). BS EN ISO 5364 specifies requirenwnts for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing mechanism. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7000, Graphical symbols for use on equipment — Registered symbols ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 11607-1, Packaging for terminally sterilized medical devices — Part .1: Requirements for materials, sterile barrier systems and packaging systems…

  • ISO 5359-2014 pdf free.Anaesthetic and respiratory equipment一Low-pressure hose assemblies for use with medical gases. ISO 5359 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: — oxygen, — nitrous oxide, — medical air, — helium, — carbon dioxide, — xenon, — specified mixtures of the gases listed above, — oxygen-enriched air, — air for driving surgical tools, — nitrogen for driving surgical tools, and for use with vacuum. 1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. 1.3 This International Standard does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies. NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA V-S 1281. NOTE 2 Specifications forthe dimensions and allocation of sleeve indexed system (S1S) connectors are specified in AS 2896 1231. NOTE 3 DimensIons and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in ISO 18082 1111. NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1. 1.4 This International Standard does not specify requirements for coaxial…