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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)

  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

Friday 17th of November 2017

  Amendment

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

  Reference

This standard supersedes the "EN 1422:1997"

Anyway is still possible use the "EN 1422:1997" until March 21st, 2010

  Related Standards

EN ISO 7396-2:2007

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

EN ISO 10524-2:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

EN 1820:2005+A1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 12470-2:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

EN 13544-1:2007+A1:2009

Medical devices Directive (93/42/EEC)

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

EN 13544-2:2002+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 2: Tubing and connectors

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