|
|
|
|
|
|
by thomasthorpe
745 days ago
|
|
|
Yes, well, some. To gain certification, often something customers require, medical devices must comply with standards such as ISO60601 (hardware) ISO62304 (software) and ISO13485 (process, quality management). The alarm waveforms described are within the scope of the hardware standard guidelines, sufficiently common that application notes such as this exist.
https://www.ti.com/lit/pdf/slaaec3 [ti.com] |
|
|
A bit more than that. Certification is required in order to put your product on the market. Whether or not customers require it is irrelevant.