Need help?

EN 1422:1997/A1:2009 Standard

wave
Save  

  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 23328-2:2009

Medical devices Directive (93/42/EEC)

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

EN 13544-2:2002+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 2: Tubing and connectors

EN ISO 9170-2:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 9360-2:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HME...

EN ISO 10079-1:2009

Medical devices Directive (93/42/EEC)

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 1422:1997/A1:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0