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Wireless Data Logger EBI 10 for Validation

Wireless Data Logger EBI 10 for Validation

Product catalog summary

Overview: The document provides a detailed description of the EBI 10 Wireless Data Logger system used for process validation in medical settings, specifically for steam-sterilizers and washer-disinfectors, in compliance with ISO 17665 and ISO 15883 standards.

System Components:

EBI Series Data Loggers: Devices for measuring and recording temperature, pressure, and time during process conditions.
Winlog.validation Software: A user-friendly software for programming, evaluation, calibration, and report generation, compliant with FDA 21 CFR Part 11.

Validation Process:

The system supports validation in various environments such as steam-sterilizers, washer-disinfectors, freeze dryers, and more.
Validation involves using data loggers to ensure processes meet international standards (EN 285, ISO 17665, ISO 15883).

Data Logger Specifications:

Temperature measurement range: -50 °C to +150 °C.
Pressure measurement range: 1 mbar to 4,000 mbar.
Memory capacity: 100,000 measurements.
Protection class: IP 68 (NEMA 6).

Validation Sets:

SL 2000: For washer-disinfectors, includes temperature and pressure data loggers, interface, software, and testers.
SL 3000: For small steam-sterilizers, includes temperature/pressure logger, interface, software, and protection box.
SL 3100: For steam-sterilizers, includes multiple temperature data loggers, interface, software, and testers.

Standards and Recommendations:

Compliance with ISO EN 17665, EN 285, and ISO 15883 is essential for ensuring safety and effectiveness in medical product processing.
Process validation requires specific numbers of temperature and pressure sensors depending on the equipment size and type.

Technical Requirements:

System requires a CPU with at least 1 GHz, 1 GB RAM, 5 GB free disk space, and compatible with Windows XP, Vista, or 7.

Catalog excerpts

Wireless Data Logger EBI 10 for Validation-1

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

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Wireless Data Logger EBI 10 for Validation-2

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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Wireless Data Logger EBI 10 for Validation-3

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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Wireless Data Logger EBI 10 for Validation-4

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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Wireless Data Logger EBI 10 for Validation-5

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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Wireless Data Logger EBI 10 for Validation-6

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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Wireless Data Logger EBI 10 for Validation

Wireless Data Logger EBI 10 for Validation

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