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EN 1422:1997+A1:2009 Standard

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  Keywords:

#type #mixed #gas #types #respectively

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

  Purpose

This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. The two types of sterilizers have been designated Type A and Type B respectively using the following criteria: - Type A sterilizers are capable of being programmed by the user; - Type B sterilizers are of limited size and provided with one or more pre-set operating cycles which cannot be varied by the user.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 1422:1997"

  Related Standards

EN ISO 8359:2009

Medical devices Directive (93/42/EEC)

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN ISO 10524-3:2006

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Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN 13544-1:2007+A1:2009

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Respiratory therapy equipment - Part 1: Nebulizing systems and their component

EN 13544-2:2002+A1:2009

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Respiratory therapy equipment - Part 2: Tubing and connectors

EN 13976-2:2018

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Rescue systems - Transportation of incubators - Part 2: System requirements

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

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