Medical devices - Free ASTM Standards Download

AS 5330:2019 pdf free download

AS 5330:2019 pdf free download.Drying cabinets for reusable medical devices. Adjustable support brackets, adjustable feet, and levelling bolts fitted to the framework shall be of stainless steel or other suitable material that is corrosion resistant. 1.6 External...

09-07-2021

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AS ISO 14971:2020 pdf download

AS ISO 14971:2020 pdf download.Medical devices - Application of risk management to medical devices. 4.3 Competence of personnel Persons performing risk management tasks shall be competent on the basis of education, training, skills and experience appropriate to...

09-03-2021

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IEC TR 62366-2-2016 pdf download Guidance on the application of usability engineering to medical devices

IEC TR 62366-2-2016 pdf download.Medical devices - Part 2: Guidance on the application of usability engineering to medical devices. The intended reader for this technical report includes the people or organisations that are involved with planning, funding,...

07-24-2021

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IEC 62366-1-2015 pdf free download Medical devices – Part 1: Application of usability engineering to medical devices

IEC 62366-1-2015 pdf free download.Medical devices - Part 1: Application of usability engineering to medical devices. 4 Principles 4.1 General requirements 4.1.1 USABILITY ENGINEERING PROCESS The MANUFACTURER shall establish, document, implement and maintain a USABILITY ENGINEERING PROCESS,...

07-22-2021

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