Wireless Data Logger EBI 10 for Validation - 6 Pages

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Catalogue excerpts

Wireless Data Logger EBI 10 for Validation Process validation according to ISO 17665 / ISO 15883 Medical | CSSD

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Only 3 Easy Steps …ebro ® Validation systems Setup Evaluate 1 2 Report 3 Quick and easy validation The ebro Winlog validation system is a combination of high accuracy dataloggers and powerful reporting and evaluation software. The system consists of: EBI series Data Loggers: Measurement systems: TÜV validation, FDA 21 CFR Part 11 conform, IQ / OQ documentation, allows evaluation according to international standards (EN 285, ISO 17665, ISO 15883) Winlog.validation Datalogger to measure and record process conditions (temperature, pressure, time). Easy-to-use software for programming, evaluation,...

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Process validation Temperature Data Logger Technical Data Temperature measurement range Pressure measurement range Temperature resolution Pressure resolution Temperature accuracy Pressure accuracy Sampling rate Measurement mode Housing material Protection class 2, 3 or 4 (probes are factory replaceable) endless, start / stop time, start immediately, start immediately until end of memory stainless steel (V4A) / PEEK Temperature Data Logger Temperature / Pressure Data Logger Temperature / Pressure Data Logger

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Accessories EBI 10 Cable Logger Probe AL 171 PT1000 PTFE coated Probe length = 3 cm Probe diameter = 1.2 mm Cable length = 1,200 mm Process validation in washer-disinfectors and steam steam-sterilizers Temperature and pressure loggers complying with the requirements of the standard EN ISO 15883-1 must be used during the process validation in washer-disinfectors. The sensors are placed between the instruments and in proximity to the washer-disinfector‘s own measurement points. In addition, measurement points must be selected on the load carriers and on the chamber walls of the washer-disinfectors....

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Process validation in steam-sterilizers Laws and Standards Various laws and standards call for appropriate validated processes in order to avoid hazards for patients and hospital staff emanating from processed medical products. These regulations are based on the standards ISO EN 17665, EN 285 (steam-sterilizers), or pr DIN 58929 / DIN EN 13060 (small steam-sterilizers) as well as ISO 15883 (washer-disinfectors). The aim of the technical validation process is to provide a documented verification that each particular steam-sterilizer supplies the sterilization results required. Thermoelectric measurements...

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ebro® Electronic GmbH Peringerstraße 10 • D-85055 Ingolstadt Tel. +49 (0) 841 - 9 54 78-0 Fax +49 (0) 841 - 9 54 78-80 Internet: www.ebro.com e-Mail: info @ ebro.com All names are registered tradenames or trademarks of ebro® Electronic GmbH -Specifications are subject to change without notice-

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