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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 5th of January 2022

  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 10651-4:2009

Medical devices Directive (93/42/EEC)

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

EN 1789:2020

Medical devices Directive (93/42/EEC)

Medical vehicles and their equipment - Road ambulances

EN ISO 11979-8:2009

Medical devices Directive (93/42/EEC)

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

EN ISO 12870:2009

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

EN 13060:2014

Medical devices Directive (93/42/EEC)

Small steam sterilizers

EN ISO 13408-5:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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