IEC 60601 3rd Edition – The 3 Collaterals
Collateral, Design, Development, Risk Management, Software, Usability, Validation, Verification
In a previous Device Tip I mentioned that one of the key aspects of IEC 60601-1 3rd edition was the introduction of three Collateral Standards that are for design and development processes, not Standards that can be confirmed through testing and inspection of the product. I refer to these as the Process Collateral Standards. The three processes are:
- Risk Management
- Usability
- Software
There are actually five Standards covering these three areas, although one of the five is no longer used:
- ISO 14971 – Risk Management
- IEC 60601-1-6 and IEC 62366 – Usability
- IEC 60601-1-4 (PEMS, obsolete) and IEC 62304 – Software
So since these are related to the design and development process itself, here’s the tip:
Integrate the 3 Collaterals into the regular Design and Development process by following the same 5 major steps of Planning, Input, Output, Verification and Validation.
More Info
The FDA Design Control process comprises the following major elements:
- Design and Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design History File
- Design Changes
Similarly, each of the (3) Process Collateral Standards describe a very similar list of major elements, that can be aligned with the major elements of the Design Control process.
| Topic: | Usability | Risk Management | Software |
|---|---|---|---|
| US Standard or Regulation: | IEC 62366-1:2015, IEC 62366:2014 | ISO 14971:2007 | IEC 62304:2015 |
| EU Standard or Regulation: | EN 62366:2008 | EN ISO 14971:2012 | EN 62304:2006 / AC:2008 |
| User Interface Design Review | |||
| Design Cycle Element: | Document | Document | Document |
| Design and Development Planning: | Usability Engineering Plan | Risk Management Plan | Software Development Plan |
| Design Input: | Usability Specification | 1. Product Requirements 2. Usability Hazards 3. Software Risks |
Software Requirements Specification (SRS) |
| Design Output: | User Interface Design | 1. Hazard Analysis 2. Failure Modes Effects Analysis 3. or combined Risk Analysis |
1. Software Architecture document 2. Software Design Specification (SDS) |
| Design Review: | Risk Analysis Review | Software Design Review | |
| Design Verification: | User Interface Verification | Design Verification | Software Verification |
| Design Validation: | Usability Validation | Design Validation | Software Validation |
| Design Transfer: | User Interface Design | Risk Analysis | Software Build document |
| Design History File: | Usability Engineering File | Risk Management File | Design History File |
| Design Changes: | Usability Engineering File | Risk Management File | Design History File |
This chart shows how easy it is to integrate the 3 Collaterals into the regular Design and Development process, without inventing an entirely new process.
Bob Duffy Associates has developed a matrix that shows how easy it is to integrate the 3 Collaterals into the regular Design and Development process, without inventing an entirely new process.
To get a copy of this matrix, please contact us.