Testing Products for ISO 11040-4/-6
APP-ISO-11040
Application Insight:
Stiction: The Break-loose force is the static friction spike before the plunger moves.
Compliant Hardware Solution
100-250-12
This machine has been validated to meet the specific requirements of this standard.
View Machine DetailsRegulatory & Test Details
| App Id | APP-ISO-11040 |
|---|---|
| App Standard | ISO 11040-4/-6 |
| Standard Organization | ISO |
| Test Type | Compression / Tension |
| Material Type | Medical Device |
| Specimen Type | Assembled Syringe |
| Industry Type | Biomedical |
| Min Force Kn | 0.005 |
| Max Force Kn | 0.1 |
| Min Spd Mm/m | 1 |
| Max Spd Mm/m | 500 |
| Expert Spd | 1mm for break-loose; 500mm for travel. |
| Mach Recommend | 100-250-12 |
| Pointer App Software | N-ISO-11040-4/-6 |
| Pointer Fixture Family | G-ISO-11040-4/-6 |
| Pointer Strain Family | E-ISO-11040-4/-6 |
Implementation Commentary
This is the Gold Standard for injectable drugs; every batch must be tested for patient safety.