Reference number
ϲʿ 80369-1:2010
ϲʿ 80369-1:2010
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
Edition 1
2010-12
Retirada
ϲʿ 80369-1:2010
45976
Retirada (徱ó 1, 2010)

Resumen

ϲʿ 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

ϲʿ 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These healthcare fields of use include, but are not limited to, applications for:

  • breathing systems and driving gases,
  • enteral and gastric,
  • urethral and urinary,
  • limb cuff inflation,
  • neuraxial devices, and
  • intravascular or hypodermic.

Small-bore connectors as specified in ϲʿ 80369-1:2010 are non-interconnectable with:

  • the cones and sockets of ϲʿ 5356-1:2004 and ϲʿ 5356-2:2006;
  • the temperature sensor connector and mating ports specified in Annex DD of ϲʿ 8185:2007; and
  • the nipples of EN 13544-2:2002.

ϲʿ 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

Informaciones generales

  •  : Retirada
     : 2010-12
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 17
  • ϲʿ/TC 210
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