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ATS2015 Mucin/Bone IFU


5.2.3.1 Verification of Cleaning

The authors of this Guideline believe that there is an urgent need to use test soils that can be compared with representative contaminants encountered in everyday practice.

http://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2017664:2004

http://www.wfhss.com/html/educ/qtg/ak_q_0045_4_2006_en.pdf

The manufacturers of narrow-lumened MDs are required by DIN EN ISO 17664 to provide Ü INFORMATION ON DECONTAMINATION, specifying at least one process for cleaning, disinfection, and for sterilisation if applicable. And since this information has implications as far as a declaration of conformity with corresponding product liability is concerned, the manufacturers carry out extensive tests or have these conducted by qualified laboratories.

Validated decontamination can be carried out only in suitable WDs provided that the materials of which the MDs are made are amenable to decontamination with thermal disinfection. The process steps involved here are cleaning, rinsing off of process chemicals, thermal disinfection and drying. Only if validated processes are used can one assume that a successful outcome is continually assured for such processes.

EN/ISO 17664

3.5 Cleaning A validated method of cleaning shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued. Where appropriate, at least the following information shall be included: .accessories required for cleaning process; .identification and concentration of chemicals required for cleaning; .identification of water quality, .limits and monitoring of chemical residues .limits on temperature, concentration of solution(s), exposure time, .process temperature(s); .techniques to be used including rinsing;