Needle protection
| Reference number | |
| Coordinator | HEMCHECK SWEDEN AB |
| Funding from Vinnova | SEK 71 000 |
| Project duration | August 2016 - December 2016 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The aim of the project was that show in a traceable matter that the newly developed needle protection fulfils the regulatory needs which guarantee that product in the best way protects the user from needle inflicted injuries. We conclude that the project has fulfil the aims by showing the needle protection mechanically meets the standard SS-EN ISO 23908:2013 and that all tests and documentations have been performed in a traceable and regulatory correct matter.
Expected results and effects
The force for activating the needle protection (locking it up) according to intended use was determine to 7N. The overriding force for an unused unit was determined to 37N. When the force was applied in 10 degree angle the overriding force was 25N. The overriding force for a used unit was determined to 35N. When the force was applied in 10 degree angle the overriding force was 25N. All results were within the determined acceptance criteria.
Planned approach and implementation
1. Evaluate the damands in SS-EN ISO 23908:2013. 2. Risk analysis. Determination of acceptance criteria. 3. Construction and manufacturing of measurement equipment. 4. Measurements 5. Calculations and presentation of data 6. Reporting