Standard [CURRENT]
DIN EN ISO 11138-5:2017-07
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
- German title
- Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 5: Biologische Indikatoren für Sterilisationsverfahren mit Niedertemperatur-Dampf-Formaldehyd (ISO 11138-5:2017); Deutsche Fassung EN ISO 11138-5:2017
- Publication date
- 2017-07
- Original language
- German
- Pages
- 16
- Publication date
- 2017-07
- Original language
- German
- Pages
- 16
- DOI
- https://dx.doi.org/10.31030/2576969
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This part of IEC 11183 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. Compared to DIN EN ISO 11138-5 from 2006-09, the requirement for the determination of resistance characteristics has been revised and Annex ZA on the relationship between the European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN). The responsible German committee is Working Committee NA 063-04-08 AA "Indikatoren" ("Indicators") at DIN Standards Committee Medicine.
This document replaces DIN EN ISO 11138-5 Berichtigung 1:2007-09 , DIN EN ISO 11138-5:2006-09 .