1、 FEDEGARI BIER GENERAL FEATURES

Fedegari 生物指示物(BI)抗力測(cè)試儀基本特點(diǎn)

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 生物指示物抗力測(cè)試儀是用于鑒定生物指標(biāo)（BI）以驗(yàn)證或確定D值（熱阻值）和z值（溫度系數(shù)）的設(shè)備。

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.

該設(shè)備可與不同類(lèi)型（固體或液體）的生物指標(biāo)劑一起使用，并可從滅 菌器中取出，以使高壓滅 菌器在正常的滅 菌活動(dòng)中工作，而不會(huì)在滅 菌器中產(chǎn)生任何阻礙

The main features of the equipment are:

設(shè)備的主要特點(diǎn)：

Cost-effective

性價(jià)比高

It is an option in a standard validated autoclave;

這是標(biāo)準(zhǔn)驗(yàn)證過(guò)的高壓滅 菌器的一個(gè)改版

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

高壓滅 菌器既可以用作滅 菌器，也可以作消 毒，也可以作為抗力測(cè)試儀使用。

Easy to use;

易于使用

High speed in BI conditioning

鑒定生物指標(biāo)（BI）調(diào)價(jià)快速

Compliance with International Norms and Guidelines:

遵守國(guó)際規(guī)范和準(zhǔn)則:

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

試驗(yàn)滅 菌器和滅 菌過(guò)程的生物系統(tǒng).用在濕熱滅 菌器的特殊系統(tǒng)

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

ISO/CD 11138-3:健康產(chǎn)品的滅 菌。生物指標(biāo)-第3部分：濕熱滅 菌過(guò)程的生物指標(biāo)。

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

抗力測(cè)試儀用于測(cè)定生物或化學(xué)指示劑的性能

REFERENCES

2、重要用戶

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

Fedegari

生物指示劑抗力測(cè)定儀 BIER已經(jīng)在在符合條件的用戶實(shí)驗(yàn)室完成安裝的實(shí)驗(yàn)室如下

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

美國(guó)FDA,食品安全技術(shù)國(guó)家實(shí)驗(yàn)室

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

SGM Biotech公司作為Mesa Labs的一個(gè)部門(mén)，是世界上專門(mén)生產(chǎn)和研發(fā)生物指示劑的獨(dú)立廠商。

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

PDA美國(guó)注射藥 物協(xié)會(huì)總部