EN 867-4:2000

Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration EN 867-4:2000

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Mar 15, 2007

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080   Sterilization and disinfection

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Scope

This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative
to the Bowie and Dick test for steam sterilizers for wrapped goods (instruments etc. and porous loads). An indicator complying with this European Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This European standard does not specify requirements for the test load but specifies the performance of the indicator system in combination with the test load with which it is intended to be used. The indicator specified in this European standard is intended to identify poor steam penetration but does not indicate necessarily the cause of this poor steam penetration. The Bowie and Dick Test is performed to demonstrate conformance of a steam sterilizer for wrapped goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see EN 554). The method of carrying out the test is described in EN 285. This European standard does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
EN 867-4:2000
99.60 Withdrawal effective
Mar 15, 2007

REVISED BY

PUBLISHED
EN ISO 11140-4:2007

Relations

Adopted from BS 7720:1994 IDENTICAL