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ISO - ISO 13485 — Medical devices
- https://www.iso.org/iso-13485-medical-devices.html
- ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing …
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 13485:2016 - Medical devices — Quality …
- https://www.iso.org/standard/59752.html
- Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. …
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 …
Ultimate List of ISO Standards for Medical Devices
- https://www.greenlight.guru/blog/iso-standards
- Oct 5, 2022
ISO - ISO 16142-1:2016 - Medical devices — …
- https://www.iso.org/standard/63939.html
- ISO 16142:2016, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a …
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 medical …
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 …
ISO - 11.040.01 - Medical equipment in general
- https://www.iso.org/ics/11.040.01.html
- Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part ...
ISO - ISO 15223-1:2016 - Medical devices — Symbols to …
- https://www.iso.org/standard/69081.html
- ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols …
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