IDI - Irish Decontamination Institute...

IDI - Irish Decontamination Institute

NOTE: These WFHSS web archive pages are not maintained anymore. Please visit wfhss.com for current WFHSS affairs.
/ IDI - Irish Decontamination Institute / Publications / Periodicals / Central Service / Central Service Archive / Central Service 6/2012
Central Service - Issue 6/2012

Central Service - Issue 6/2012

Central Service - Issue 6/2012

NEWS UPDATE

  • What's New in Standardisation: Drafts
  • The Institute of Decontamination Sciences (IDSc) Annual Conference 2012
  • David Hurrell
  • A new member for the Central Service Editorial board
  • Validation of small steam sterilizers in the healthcare sector according to ISO 17665-1

ORIGINAL ARTICLE

J.P.C.M. van Doornmalen, R. J. Hermsen and K. Kopinga:
Six commercially available Class 6 Chemical Indicators tested against their stated values

Abstract
Objective: To assess whether ISO 11140 part 1 class 6 Chemical Indicators (CI s) for steam sterilization actually meet their claimed Stated Values (SVs). SVs for steam sterilization represent a temperature-time combination at which the CI has to give an unambiguous pass result, e. g. at 134 C after 3.5 minutes in saturated steam.
Design: Six types (brands) of commercially available ISO 11140 part 1 class 6 CI s were purchased and investigated. These CI s were exposed to saturated steam at 134 C. The exposure time was varied from 1 s to 15 minutes. At the SVs of the indicator it has to show an unambiguous color change towards the reference color. This color change indicates a pass result.
Method: After exposure of the CI s to saturated steam the indicator ink and the reference color on the CI strip were read out immediately. To avoid observer-dependent results these readings were obtained from a spectrodensitometer.
Results: Only one type of the six class 6 CI s actually reached its reference color and showed a color change close to its SVs.
Conclusions: Class 6 CI s have only a very limited added value and in most cases their use may lead to conclusions that are unreliable and even unsafe.

Keywords:
steam sterilization monitoring Class 6 Chemical Indicators ISO 11140

RECOMMENDATIONS

Recommendations by the «Quality Task Group»: DGSV Flow Chart 2012 for Classification of Medical Devices


Publisher
Information on this page provided with kind permission of: mhp-verlag GmbH
Address: Marktplatz 13
65183 Wiesbaden
Germany
Phone: +49-(0)611-50593 0
Fax: +49-(0)611-50593 11
Web: www.mhp-verlag.de
E-mail:

mhp stands for publications in medicine, hygiene and prevention. For more than 20 years, the mhp publishing house has devoted itself to supporting developments aiming for a better standard of hygiene and infection control in hospitals and other medical facilities.

Free Access to Central Service E-Paper
Since 2008 Central Service has also been available as electronic E-Paper version. Subscriptions are possible to the print issue only, the online E-Paper issue only, or as a combined subscription to both. A free E-Paper version of back issues of Central Service is now available for subscribers to the print issue (starting from Volume 16, 2008). Please contact to order your free E-Paper access code.

Archive