5. Link with IEC 62304 Requirements¶

The [IEC 62304:2006 + AMD 1:2015] requirements describe the consideration of software tools with respect to:

1. Planning of tool usage in the software development plan (Section 5.1.4)

2. Supporting items to be controlled, including tools, items or settings used to develop the medical device software (Section 5.1.10)

3. Documentation of the procedures used to release the software, including the retrieval of tools used (Section B.5.8)

4. Recommendations of techniques, tools and methods, following the principles of [IEC-61508:2010], encouraging the usage of [IEC-61508:2010] as source of good software methods (Section C.7)

As there is no specific method defined in IEC 62304 to qualify tools, but the usage of good software practices of [IEC-61508:2010] is encouraged, the application of tool classification and qualification according to [IEC-61508:2010] is used to qualify Ferrocene.

In addition, Ferrocene follows an open source development model. Nevertheless, Ferrocene is the qualified version of the open source Rust toolchain, and will therefore follow a development process in accordance to [ISO-26262:2018] Clause 11.4.8, as well as classification accordance to [IEC-61508:2010].

In order to respect these three steps, we’ll manage five documents:

• Ferrocene Evaluation Plan

• Ferrocene Evaluation Report

• Ferrocene Qualification Plan

• Ferrocene Qualification Report

• Ferrocene Safety Manual

The Ferrocene Safety Manual describes the usage, constraints, and limitations of the tool according to this qualification:

• Description of the tool usage and other information (configuration data, environment, settings etc.).

• List of the potential errors with mitigations or workarounds to enable risk management.

Following the recommendation of following best principles of [IEC-61508:2010], the Link with IEC 61508 Requirements describes how the tool qualification activities of [IEC-61508:2010] are applied.