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ISO - ISO 13485 — Medical devices
- https://www.iso.org/iso-13485-medical-devices.html
- A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Who is ISO 13485 for? ISO 13485 is designed to be used by …
ISO - ISO 13485:2016 - Medical devices …
- https://www.iso.org/standard/59752.html
- ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to …
ISO - ISO 20417:2021 - Medical devices — Information …
- https://www.iso.org/standard/67943.html
- NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer …
ISO - ISO 14155:2020 - Clinical investigation of medical …
- https://www.iso.org/standard/71690.html
- — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. NOTE 1 …
Medical devices - ISO
- http://policy.iso.org/medical-devices.html
- The medical devices industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes and needles, is both rapidly …
Ultimate List of ISO Standards for Medical Devices
- https://www.greenlight.guru/blog/iso-standards
- Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet …
ISO - ISO 14971:2019 - Medical devices — Application of …
- https://www.iso.org/standard/72704.html
- This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic …
Sterilization for Medical Devices | FDA
- https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
- Medical devices are sterilized in various ways, including ethylene oxide and radiation. Read more on the FDA’s actions to advance medical device sterilization. ...
ISO - New ISO standards for medical devices
- https://www.iso.org/news/ref2534.html
- ISO 20417, Medical devices – Information to be supplied by the manufacturer, simplifies the process of meeting product information regulations by providing common …
ISO - ISO 15223-1:2016 - Medical devices — Symbols to …
- https://www.iso.org/standard/69081.html
- ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory …
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