Document Detail

An international standard for terminally sterilized medical device packaging.
MedLine Citation:
PMID:  10169623     Owner:  NLM     Status:  MEDLINE    
Manufacturers of terminally sterilized medical devices must ensure that packaging protects the device from damage, allows it to be sterilized, and provides an effective barrier against microbiological contamination. The previous article in this column discussed quality system requirements for packaging. Recently, an international standard concerning sterile packaging has been developed and this article provides an overview of the standard.
M E Donawa
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical device technology     Volume:  8     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:    1997 Jul-Aug
Date Detail:
Created Date:  1997-09-23     Completed Date:  1997-09-23     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  10-2     Citation Subset:  T    
Donawa and Associates Ltd, Rome, Italy.
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MeSH Terms
Equipment and Supplies*
Materials Testing / standards*
Product Packaging / standards*
Quality Assurance, Health Care*
Reproducibility of Results
Sterilization / standards*
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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