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Re: Searching for applicable Standards for a Medical Device using electronics, softwa
Hi Sherwood,
Don't forget (if you had not found it yet/considered) the IEC/EN 60601-1 series. Also have a look at http://www.meddev.info/_documents/R2_2-4_rev5.pdf for software essentials.
You mention pneumatics - I suppose this could possibly take in electrical medical suction - EN ISO 10079-1.
Steve
Hi Sherwood,
Don't forget (if you had not found it yet/considered) the IEC/EN 60601-1 series. Also have a look at http://www.meddev.info/_documents/R2_2-4_rev5.pdf for software essentials.
You mention pneumatics - I suppose this could possibly take in electrical medical suction - EN ISO 10079-1.

Steve