Preliminary Results for a New Final Package Test to Assess the Quality of Sterile Package Systems

Infection Control and Hospital Epidemiology

Volumn 25, Issue 1, 2004, Pages 26-29

  Dunkelberg, Hartmut ^a   Wedekind, Silke ^a  

^a UNIVERSITY OF GÖTTINGEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AIRBORNE PARTICLE; ARTICLE; BACTERIAL COUNT; BACTERIUM CULTURE; INSTRUMENT STERILIZATION; LABORATORY TEST; MECHANICAL STRESS; MICROBIAL CONTAMINATION; PACKAGING; PRESSURE; QUALITY CONTROL;

CENTRAL SUPPLY, HOSPITAL; COLONY COUNT, MICROBIAL; EQUIPMENT CONTAMINATION; HUMANS; MATERIALS TESTING; PAPER; PRODUCT PACKAGING; QUALITY CONTROL; STERILIZATION; STRESS, MECHANICAL;

EID: 0942287841     PISSN: 0899823X     EISSN: None     Source Type: Journal    
DOI: 10.1086/502287     Document Type: Article

References (13)

1. American Society for Testing and Materials. F2097-01: Standard Guide for Design and Evaluation of Primary Packaging for Medical Products. West Conshohocken, PA: American Society for Testing and Materials International; 2002.
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3. European Committee for Standardization. EN 868-1: Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1. General Requirements and Test Methods. Brussels: European Committee for Standardization; 1997.
4. European Committee for Standardization. EN 556-1: Requirements for Medical Devices to Be Designated "STERILE" - Part 1. Requirements for Terminally Sterilized Medical Devices. Brussels: European Committee for Standardization; 2001.
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10. Standard PG, Mackel DC, Mallison GF. Microbial penetration of muslin- and paper-wrapped sterile packs stored on open shelves and in closed cabinets. Appl Microbiol 1971;22:432-437.
11. Standard PG, Mallison GF, Mackel DC. Microbial penetration through three types of double wrappers for sterile packs. Appl Microbiol 1973;26:59-62.
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13. Junghannß U, Winterfeld S, Gabele L, Kulow U. Hygienic-microbiological and technical testing of sterilizer container systems. Zentral Sterilisation 1999;7:154-162.