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EN ISO 8185:2009 Standard

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  Keywords:

#breathing #tubes #heated #performance #international

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

  Purpose

This International Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This International Standard also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 8185:2007"

Anyway is still possible use the "EN ISO 8185:2007" until March 21st, 2010

  Related Standards

EN ISO 14630:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - General requirements (ISO 14630:2008)

EN ISO 5366-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN ISO 7396-1:2007/A2:2010

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007/A1:2010

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7376:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

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