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Can I read Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer on EtoBox?
Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer by ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems is a reference work available to read on EtoBox.
What is Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer about?
ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included. Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. IVD medical devices for self-testing are excluded.
Who reads Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer?
It is typically read by working professionals who need an authoritative practice reference.
Common subject areas: medicine, law, business, engineering.
- Author
- ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
- Publisher
- ISO
- Published
- 2005
- Language
- EN
- Category
- reference
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