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The standard's two parts outline requirements for terminally sterilized medical devices. Part 1 (ISO 11607-1) describes requirements for materials, sterile-barrier systems, and packaging systems. Part 2 (ISO 11607-2) outlines validation requirements for secondary operations such as cutting and...

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Bibliographic Details
Published inMedical design news Vol. 8; no. 7; p. 26
Main Author Petrie, Glenn
Format Magazine Article
LanguageEnglish
Published Cleveland Informa 01.09.2008
Subjects
Design
ISO standards
Manufacturing
Materials selection
Medical equipment
Package design
Quality control
Raw materials
Suppliers
United States > US
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Summary:The standard's two parts outline requirements for terminally sterilized medical devices. Part 1 (ISO 11607-1) describes requirements for materials, sterile-barrier systems, and packaging systems. Part 2 (ISO 11607-2) outlines validation requirements for secondary operations such as cutting and sealing. Companies may also use European standard EN868-2 to EN868-10 to show compliance with the ISO standard.
Bibliography:content type line 24
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SourceType-Magazines-1
ISSN:1541-2733