Test unit and method for testing whether a sterilizing...

Package making – Methods – Sterilizing complete package

Reexamination Certificate

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C435S031000

Reexamination Certificate

active

07874128

ABSTRACT:
A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.

REFERENCES:
patent: 4596773 (1986-06-01), Wheeler, Jr.
patent: 4717661 (1988-01-01), McCormick et al.
patent: 4743537 (1988-05-01), McCormick et al.
patent: 4925789 (1990-05-01), Edberg
patent: 5167923 (1992-12-01), Van Iperen
patent: 5344017 (1994-09-01), Wittrock
patent: 5863496 (1999-01-01), McElhany
patent: 5922592 (1999-07-01), Tautvydas
patent: 5955296 (1999-09-01), Roll
patent: 6770454 (2004-08-01), Reilly et al.
patent: 2002/0022246 (2002-02-01), Lin et al.
patent: 2005/0191750 (2005-09-01), Dunkelberg
patent: 10006767 (2000-02-01), None
patent: 102 13 361 (2004-01-01), None
patent: 2186974 (1997-08-01), None
patent: 0113964 (2001-03-01), None
AESCULAP, Basci version of Sterile Containers B. Braun Melsungen AG, http://www.bbraun.com/index.cfm?uuid=97E644D8B349489E89, Apr. 11, 2004; one sheet.
European Standard, EN 556-1, Sterilization of medical devices—Requirements for medical devices to be designated ‘STERILE’, pp. 1-6, Oct. 2001.
European Standard, EN 868-1, Verpackungsmaterialien und-system fur zu sterilisierende Medizinprodukte, pp. 1-12, Feb. 1997.
A.C.P. de Bruijn and J. Kastelein, Single or Multiple Wrapping of Medical Devices: Procedure Assessment Through Research, Zentr Steril vol. 7, pp. 292-303, Jan. 1999.
U. Junghannss, S. Winterfeld, L. Gabele and U. Kulow, Hygienic-Microbiological and Technical Testing of Steriliser Container Systems, Zentr Steril vol. 7, pp. 154-162, Jan. 1999.
H. Dunkelberg, S. Wedekind, A New Method for Testing the Effectiveness of the Microbial Barrier Properties of Packaging Materials for Sterile Products, Biomedizinische Technik, Band 47, 290-293, Heft Nov. 2002.
The Society for Healthcare Epidemiology of America 13th Annual Scientific Meeting, Meeting Information, Hartmut Dunkelberg, MD, Bjorn Zietz, MD, and Silke Wedekind, Preliminary Results for a New Final Package Test to Assess the Quality of Sterile Package Systems, pp. 1 and 101, Section 214, Monday, Apr. 7, 2003.
AESCULAP, Sterile Containers, Instructions for use/Technical description, Dec. 1997.
“gke-Bio-Plus-Indikatoren,” Bio-Plus D/Stand, Sep. 1999.
“Deutsche Norm Sterilgutversorgung,” DIN 58 953, Jan. 1997.
H. Dunkelberg, S. Wedekind, Rekontamination von papierverpackten Sterilgutpaketen unter mechanischer Belastung, Hyg Med, Jan. 27, 2002.
3M Media, 1 page.
American Society for Testing Materials (ASTM), Lizensierter Nachdruck, Standard Test Method for Microbial Ranking of Porous Packing Materials (Exposure Chamber Method), Designation F-1608-00, Jun. 2000.
American Society for Testing Materials (ASTM), Lizensierter Nachdruck, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products, Designation F 2097-01, Dec. 2001.

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