NF EN ISO 5362

NF EN ISO 5362

September 2019
Standard Current

Anaesthetic reservoir bags

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life.ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags.Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2019

Number of pages

22 p.

Reference

NF EN ISO 5362

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-113

Print number

1

International kinship

ISO 5362:2006

European kinship

EN ISO 5362:2019
Sumary
Anaesthetic reservoir bags

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.

ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life.

ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags.

Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

Replaced standards (1)
NF EN 1820+A1
November 2009
Standard Cancelled
Anaesthetic reservoir bags

Le présent document fixe les prescriptions relatives aux ballons réservoirs antiélectrostatiques et non antiélectrostatiques destinés à être utilisés avec les appareils d'anesthésie ou les systèmes respiratoires de ventilateurs pulmonaires. Il fixe les prescriptions relatives à la conception du col, la désignation de la taille, la distension et, le cas échéant, les prescriptions relatives à la résistance électrique. Le présent document détermine également l'essai de fuite, la détermination de la capacité, l'essai de sûreté de branchement et de raccordement, l'essai de résistance à la pression et donne les recommandations relatives aux matériaux.

Table of contents
  • 1 Domaine d"application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Prévention des charges électrostatiques
  • 6 Exigences relatives aux ballons fournis stériles
  • 7 Marquage
  • 8 Informations à fournir par le fabricant
  • Annexe A Essai de fuite
  • Annexe B Détermination de la capacité
  • Annexe C Essai de sûreté de branchement d"un col simple à un raccord conique mâle de 22mm
  • Annexe D Essai de sûreté de raccordement de l"adaptateur du col assemblé au ballon
  • Annexe E Essai de résistance à la pression nécessaire pour distendre le ballon (pression/volume)
  • Annexe F Essai de résistance à la pression nécessaire pour distendre le ballonavec de l"air (pression/volume)
  • Annexe G Recommandations relatives aux matériaux
  • Bibliographie
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