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

Le présent document spécifie les exigences de performances qui s'appliquent à un indicateur de Classe B servant d'alternative à l'essai de Bowie-Dick pour les stérilisateurs à la vapeur d'eau utilisés pour les objets enveloppés (instruments, etc.).

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Main informations

Collections

National standards and national normative documents

Publication date

February 2001

Number of pages

40 p.

Reference

NF EN 867-4

ICS Codes

11.080.10 Sterilizing equipment

11.080.20 Disinfectants and antiseptics

Classification index

S98-006

Print number

1 - 23/10/2003

European kinship

EN 867-4:2000

Sumary

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

Le présent document spécifie les exigences de performances qui s'appliquent à un indicateur de Classe B servant d'alternative à l'essai de Bowie-Dick pour les stérilisateurs à la vapeur d'eau utilisés pour les objets enveloppés (instruments, etc.).

Standard replaced by (1)

NF EN ISO 11140-4

June 2007

Standard Current

Sterilization of health care products - Chemical indicators - Part 4 : class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 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.

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