Talk:IEC 62304

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history

What events led to the IEC 62304 standard being developed? (The Therac-25 article says the IEC 62304 standard was created "In response to incidents like those associated with Therac-25". What incidents is that alluding to?)

Are there any previous standards for medical software that the IEC 62304 obsoletes or complements? --DavidCary (talk) 17:32, 17 August 2015 (UTC)[reply]

The closest predecessors were IEC60601-1-4 and [ISO/IEC_12207]

" What incidents is that alluding to?)" to the ones described in the article itself MarmotteiNoZ 13:56, 10 August 2022 (UTC)[reply]

Documentation

The part where it says which documentation is needed is not accurate enough. It looks like class B and C need exactly the same. It is better explained on the following blog. https://www.mddionline.com/developing-medical-device-software-iec-62304

--pinar 09:03, 11 September 2017 (UTC) — Preceding unsigned comment added by Jlpinar83 (talk • contribs)