NF EN ISO 5364

NF EN ISO 5364

December 2016
Standard Current

Anaesthetic and respiratory equipment - Oropharyngeal airways

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. ISO 5364:2016 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. ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2016

Number of pages

26 p.

Reference

NF EN ISO 5364

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-114

Print number

1

International kinship

ISO 5364:2016

European kinship

EN ISO 5364:2016
Sumary
Anaesthetic and respiratory equipment - Oropharyngeal airways

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.

ISO 5364:2016 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.

ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

Replaced standards (1)
NF EN ISO 5364
July 2011
Standard Cancelled
Anaesthetic and respiratory equipment - Oropharyngeal airways

<p>ISO 5364:2008 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. 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.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Désignation des tailles et dimensions
  • 5 Matériaux
  • 6 Conception
  • 7 Exigences de performance
  • 8 Assurance de stérilité
  • 9 Emballage des canules oropharyngées fournies stériles
  • 10 Marquage
  • 11 Informations à fournir par le fabricant
  • Annexe B(normative) Méthode d'essai de la résistance à l'aplatissement de la pièce buccale
  • Annexe C(normative) Méthode d'essai de non-occlusion de la lumière
  • Annexe A(informative) Justificatif
  • Annexe D(informative) Lignes directrices relatives aux matériaux et à la conception
  • Annexe ZA(informative) Relation entre la présente norme européenne et les exigences essentielles de la Directive UE 93/42/CEE
  • Bibliographie
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