The documents covering the regulation, design and production of the Makespace Visor
For the high-level overview of this activity, see https://web.makespace.org/visor/
- Requirements – The device specification, regulations and risk assessments
- Design Files – The delve mask design files
- Materials – The materials, BOM, and data sheets
- Production – Manufacturing Standard Operating Procedure (SOP), Training and Worker/Batch Tracking
- Documentation – The accompanying documentation and labelling for shipping
The Manufacturing SOP and Manufacturing SOP checklist documents found in the production directory are the key documents describing the whole process, and the place to start if you want to learn about the activity.
The Workstation single point lessons ppt is also useful to get a feel for the activities that need to be performed.
The requirements directory is good reading for context on how the essential safety requirements mandated in regulations are fulfilled by the design and documentation. This is what is required when the UK government relaxed the rules on PPE for hospitals from ‘at least CE marked’ to ‘meet essential safety requirements’.