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Manufacturing Standards
Every instrument we manufacture meets rigorous international standards — from raw material selection through to final inspection.
For manufacturing of surgical and dental instruments, Surgical Essence first chooses the correct stainless steel grade for the required instruments, drawing on ASTM & DIN standards, the DIN book, ISO's standard manual and other suitable literature.
AISI 300 Series
Used in combination with Martensitic steel for dental instruments and specialty components such as scalar tips and elevator handles (AISI 304).
AISI 400 Series
Primary choice for general surgical instruments. Grades 410 & 420 are most widely used — 410 for non-cutting, 420 for cutting instruments.
| Grade | Application |
|---|---|
| AISI 410 | Non-Cutting Instruments |
| AISI 420 | Cutting Instruments |
| AISI 304 | Tips of Scalars & Elevator Handles |
| AISI 410 & 420 | General Surgical Instruments |
Material shall conform to the mechanical property requirements below. The table lists Brinell Hardness maximums for Class 4 Martensitic Stainless Steels in the annealed condition.
| Type | Max Brinell Hardness (HB) |
|---|---|
| 410 | 210 |
| 410X | 220 |
| 416 | 262 |
| 416 Mod | 262 |
| 420A | 220 |
| 420B | 235 |
| 420 Mod | 255 |
| 420X | 262 |
| 420C | 262 |
| 420F | 262 |
| 420F Mod | 262 |
| 431 | 285 |
| 440A | 285 |
| 440B | 285 |
| 440C | 285 |
| 440F | 285 |
Two test methods are specified for determining corrosion resistance:
Place a plastic fiber (e.g. a suture filament) of maximum diameter 0.2 mm between the jaws within the third of the length nearest the tip. Fully close the instrument and apply a tensile force of 20 N to the fiber. Record whether the fiber is pulled out from the jaws.
Place a test wire between the tips of the instrument jaws. Fully close the instrument to the last ratchet position. Leave the instrument in this position for 3 hours at room temperature. Examine for cracks and permanent deformation.
The cutting ability of instruments is tested as follows: the testing material shall be cut non-stop three times along two-thirds of the blade without lateral pressure.
All instruments must pass the following inspections before leaving the facility:
Manufacturing processes conform to ASTM & DIN standards, ISO's standard manual and other applicable literature for surgical instrument production.
