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 15223-1. Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 oropharyngeal airway
device intended to maintain a gas pathway through the oral cavity and pharynx
3.2 pharyngeal end
that end of an oropharyngeal airway (3.1) which is intended to be inserted into a patient’s oropharynx flanged end that end of an oropharyngeal airway (3.1]) which is flanged and is intended to be external to the teeth or gums [SOURCE: ISO 4135:2001, 6.1.1.1]
4 Size designation and dimensions
4.1 Size designation
The size of oropharyngeal airways shall be designated by the nominal length (see I, Eigure 1) expressed in centimetres, in accordance with Table 1.BS EN ISO 5364 pdf download.
Tags: Anaesthetic and respiratory equipment
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