If the app is to control the device (and only does this), it would be outside IEC 82304-1. IEC 82304-1 is the product standard for standalone software (including Software as Medical Device). IN the case of your device, the "product safety" standard is IEC 60601. Scope of 82304-1is: This Part of 82304 applies to the SAFETY and SECURITY ...

In 2017, the IEC 62133 standard was split into two new standards, -1 & -2. -1 is for nickel chemistries, -2 for lithium chemistries. The question is I have is to when is  IEC 62133-2:2017 likely to be a recognized consensus standard with the FDA? regards Mike ------------------------------ Mike Kilkelly Quality Manager Galway Ireland --------- ...

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