An international standard for terminally sterilized medical device packaging.
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.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004864:Equipment and Supplies; D005060:Europe; D008422:Materials Testing / Q000592:standards*; D019064:Product Packaging / Q000592:standards*; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D013242:Sterilization / Q000592:standards*; D014481:United States