Templates IEC 62304 Templates

Updated December 2, 2022

Template: Software Architecture Checklist

Sven Piechottka

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Software Architecture Checklist

Regulatory references:

IEC 62304, para. 5.3.6 [class B, C]

Relevant other documentation:

1. Checklist

Criteria Pass / Fail
The software architecture is in agreement with the software requirements. ( ) Yes
( ) Improve:
All software systems are listed and their respective safety class is stated. ( ) Yes
( ) Improve:
All software components are listed and described, including interfaces. ( ) Yes
( ) Improve:
All software units are listed and described. ( ) Yes
( ) Improve:
(Optional) Further architecture is described, e.g. databases, security and data protection requirements. ( ) Yes
( ) Improve:
The software architecture can be implemented with our given resources. ( ) Yes
( ) Improve:

2. Comments

<Insert comments if applicable>

3. Results

( ) Software Architecture passed
( ) Software Architecture not passed
( ) Software Architecture passed with the following obligations: <Insert if applicable>\


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