Bibliography
- ISO 9001:20153), Quality management systems — Requirements
- ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
- ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems
- ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements
for forming, sealing and assembly processes
- ISO 14644 (all parts), Cleanrooms and associated controlled environments
- ISO 14698 (all parts), Cleanrooms and associated controlled environments — Bio contamination
control
- ISO 14971:2007, Medical devices — Application of risk management to medical devices
- ISO 19011, Guidelines for auditing management systems
- IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
- GHTF/SGl/N055:20094), Definition of the Terms "Manufacturer", "Authorised Representative",
"Distributor" and "Importer"
- GHTF/SG5/N4:20105\ Post-Market Clinical Follow-Up Studies
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Medical Device"
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