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Cleaning Validations for Reusable Products - ANSI/AAMI TIR30:2011 Requirements

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eharfield

#1
ANSI/AAMI TIR30:2011 states that one should expect a 3 log reduction in bioburden for the purposes of a cleaning validation. Are there any other standards or guidances that provide requirements (ideally EU)?

Any help or pointers would be greatly appreciated.
 
#2
Re: Cleaning Validations for reusable products

Here is a bunch of other sources to consider:

- ISO 17664:2004, Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices: this standards is harmonized in the EU (EN ISO 17664:2004)

- its US variant ANSI/AAMI ST81:2004

- AAMI TIR12:2010

- renowned source in Germany: recommendations of the RKI
http://www.rki.de/DE/Content/Infekt.../Medprod_Rili_2012.pdf?__blob=publicationFile

HTH,

Gerhard
 
E

eharfield

#3
Re: Cleaning Validations for reusable products

Thanks!

Do you know if the RKI publication can be found in English? :)
 
#4
Re: Cleaning Validations for reusable products

To my knowledge, the RKI recommendations are available in German only, unfortunately.
 
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