Package has 5 documents
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package provides the requirements necessary to protect terminally sterilized medical devices until the point of use.
ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices also provides the requirements to be used for the development, selection, and validation of medical devices symbols. In addition, the package suggests the risk management process for terminally sterilized medical devices and the package includes:
- ISO 15223-1:2016
- ISO 15223-2:2010
- ISO 11607-1:2019
- ISO 11607-2:2019
- ISO 10993-1:2018
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Package has 5 documents
General Information
Standard
EN ISO 11607-1:2020
English language
52 pages
Standard
EN ISO 11607-2:2020
English language
21 pages
Standard
ISO 10993-1:2018 - Biological evaluation of medical devices
English language
41 pages
Standard
ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied
English language
16 pages