1、 FEDEGARI BIER GENERAL FEATURES

Fedegari 生物指示物(BI)抗力测试仪基本特点

Fedegari BIER is an equipment useful in characterization of Biological Indicators (BI) to verify or determine the D-value (Thermal Resistance Value)

and z-value (Temperature Coefficient).

Fedegari 生物指示物抗力测试仪是用于鉴定生物指标（BI）以验证或确定D值（热阻值）和z值（温度系数）的设备。

The equipment can be used with different king of BI, both liquid or solid, and can be removed from the sterilization chamber to allow the autoclave

to work in normal sterilization activities without any impediment in the chamber.

该设备可与不同类型（固体或液体）的生物指标剂一起使用，并可从灭 菌器中取出，以使高压灭 菌器在正常的灭 菌活动中工作，而不会在灭 菌器中产生任何阻碍

The main features of the equipment are:

设备的主要特点：

Cost-effective

性价比高

It is an option in a standard validated autoclave;

这是标准验证过的高压灭 菌器的一个改版

The autoclave can be used both as Sterilizer and as Resistometer.

高压灭 菌器既可以用作灭 菌器，也可以作消 毒，也可以作为抗力测试仪使用。

Easy to use;

易于使用

High speed in BI conditioning

鉴定生物指标（BI）调价快速

Compliance with International Norms and Guidelines:

遵守国际规范和准则:

EN 866-3:1999: Biological systems to test sterilizers and sterilization process. Particular systems to be used in moist steam sterilizers.

试验灭 菌器和灭 菌过程的生物系统.用在湿热灭 菌器的特殊系统

ISO/CD 11138-3: Sterilization of health care products – Biological Indicators – Part 3: Biological indicators for moist heat sterilization processes.

ISO/CD 11138-3:健康产品的灭 菌。生物指标-第3部分：湿热灭 菌过程的生物指标。

ANSI/AAMI ST44:2002: Resistometer used for characterizing the performance of biological and chemical indicators.

抗力测试仪用于测定生物或化学指示剂的性能

REFERENCES

2、重要用户

Fedegari BIER is installed in autoclaves in the laboratories of qualified users as:

Fedegari

生物指示剂抗力测定仪 BIER已经在在符合条件的用户实验室完成安装的实验室如下

Food and Drug Administration - National Center for Food Safety and Technology - 6502 S. Archer Rd. Summit - Argo, IL 60501

美国FDA,食品安全技术国家实验室

SGM Biotech, Inc. - 10 Evergreen Drive, Suite E Bozeman, MT 59715 USA

SGM Biotech公司作为Mesa Labs的一个部门，是世界上专门生产和研发生物指示剂的独立厂商。

PDA Global Headquarters - Bethesda Towers - 4350 East West Highway, Suite 200 Bethesda, MD 20814 USA.

PDA美国注射药 物协会总部