Quality-assured range of approximately 18,000 surgical instruments as well as aluminium sterilization containers
AS Medizintechnik GmbH
TuttlingenNew on Amplifa
About AS Medizintechnik
AS Medizintechnik is a family-owned company based in Tuttlingen, the world center of medical technology. The portfolio comprises approximately 18,000 standard and specialty instruments for surgery, discipline-specific instrument sets for fields such as neurosurgery, ENT, thoracic, cardiac and vascular surgery, gynecology, urology, hand and plastic surgery as well as arthroscopy, complemented by instruments for osteosynthesis and the asipco® aluminium sterilization container system with milled lids. In an in-house quality management process (AS Finish Line), every instrument is inspected (visual inspection, Rockwell hardness testing, boiling test, material testing per DIN EN ISO 7153), matted by glass bead blasting, marked corrosion-free using an ultra-short-pulse laser, pre-cleaned in ultrasonic baths, and finally cleaned and passivated with validation in four washer-disinfectors. The UDI-GS1-DataMatrix marking is verified with a calibrated verification camera according to ISO/IEC 29158. Through authorized distribution partners, the company is represented in more than 70 countries and also trains hospital operating departments on site.
- Site
- Tuttlingen
- Processes
- Laser marking using ultra-short-pulse laser (corrosion-free, high contrast, DataMatrix/UDI), Glass bead blasting (matting, glare-free surface, approx. 90% of instruments), Passivation with citric-acid-based solution (passive layer on stainless steel instruments), Corrosion protection using specially developed solutions, Pre-cleaning in ultrasonic bath (2 ultrasonic tanks), Validated final cleaning in 4 washer-disinfectors (process time approx. 90 minutes), Thermal disinfection (A0-3000 value, 90°C, 5 minutes), Hardness testing using the Rockwell method
- Materials
- Stainless steel (surgical instruments), Aluminium (asipco® containers), Ultra-short-pulse laser marking, Glass bead blasting, Passivation with citric acid, Validated cleaning and thermal disinfection
- Certificates
- Validated cleaning per DIN EN ISO 13485, UDI verification per ISO/IEC 29158, Material testing per DIN EN ISO 7153, Sterile barrier systems ISO 11607-1/-2, EN 868-8, DIN 58953-9, MDR (EU) 2017/745
- Industries
- Medical technology, Hospitals / surgery, Hospitals / surgery (specialties: neurosurgery, ENT, thoracic, cardiac
- 01
Goods receipt and batch testing of the steel (hardness, boiling, material
- 02
Visual inspection for fidelity to model and function
- 03
Glass bead blasting (matting)
- 04
Laser marking (ultra-short-pulse laser, UDI DataMatrix)
- 05
Pre-cleaning in ultrasonic bath
- 06
Validated final cleaning and thermal disinfection (WD)
- 07
Passivation and corrosion protection
- 08
UDI verification (ISO/IEC 29158)
- 09
Final inspection, function and cutting test, oiling
- 10
Packing and labeling
- 11
Worldwide distribution via authorized partners
Materials & Processes
Stainless steel (surgical instruments)
Material of the surgical instruments; tested per DIN EN ISO 7153 with hardness and boiling testing for each batch.
Aluminium (asipco® containers)
Robust, impact-resistant material of the sterilization containers; lids are milled from an aluminium block.
Ultra-short-pulse laser marking
Corrosion-free, high-contrast direct marking including DataMatrix/UDI over the entire product life cycle.
Glass bead blasting
Matts and deburrs the surface of approximately 90% of all instruments.
Passivation with citric acid
Creates a passive layer on stainless steel instruments, complemented by special corrosion protection solutions.
Validated cleaning and thermal disinfection
Pre-cleaning in two ultrasonic baths, final cleaning in four washer-disinfectors (approx. 90 minutes) plus thermal disinfection with A0-3000 (90 °C, 5 minutes).
Locations
Tuttlingen
DEHeadquarters
- Materials
- Stainless steel, aluminium
- 4 washer-disinfectors (WD)
- 2 ultrasonic tanks
- Calibrated verification camera per ISO/IEC 29158
- Ultra-short-pulse laser marking
- Glass bead blasting system
- Rockwell hardness tester
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Laser marking using ultra-short-pulse laser (corrosion-free, high contrast, DataMatrix/UDI)Surface | – | – | – | – | Stainless steel |
| Glass bead blasting (matting, glare-free surface, approx. 90% of instruments)Surface | – | – | – | – | Stainless steel |
| Passivation with citric-acid-based solution (passive layer on stainless steel instruments)Surface | – | – | – | – | Stainless steel |
| Corrosion protection using specially developed solutionsSurface | – | – | – | – | Stainless steel |
| Pre-cleaning in ultrasonic bath (2 ultrasonic tanks)Surface | – | – | – | – | Stainless steel |
| Validated final cleaning in 4 washer-disinfectors (process time approx. 90 minutes)Surface | – | – | – | – | Stainless steel |
| Thermal disinfection (A0-3000 value, 90°C, 5 minutes)Surface | – | – | – | – | – |
| Hardness testing using the Rockwell methodTesting | – | – | – | – | Stainless steel |
| Boiling test to check corrosion resistanceTesting | – | – | – | – | – |
| Material testing per DIN EN ISO 7153Testing | – | – | – | – | – |
| Visual inspection of surface and fidelity to model against technical production drawingsTesting | – | – | – | – | – |
| UDI GS1 DataMatrix verification using a calibrated verification camera per ISO/IEC 29158 andTesting | – | – | – | – | – |
| Final inspection, cutting test, function test, oiling, packing and labelingTesting | – | – | – | – | – |
| Milling of container lids from an aluminium block (asipco® container lids with Impact Protection)Machining | – | – | – | – | Aluminium |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Washer-disinfectors (WD) | – | 4 | – | – | Tuttlingen |
| Ultrasonic tanks | – | 2 | – | – | Tuttlingen |
| Verification camera (calibrated, UDI DataMatrix inspection per ISO/IEC 29158) | – | – | – | – | Tuttlingen |
Additional services
Quality Management AS Finish Line
Every instrument is visually inspected against technical production drawings; for each batch, hardness testing (Rockwell), boiling testing for corrosion resistance, and material testing per DIN EN ISO 7153 are performed. The validated final cleaning is carried out in accordance with DIN EN ISO 13485, and the UDI DataMatrix marking is verified with a calibrated camera according to ISO/IEC 29158 and TR29158.
| Evidence | Tuttlingen |
|---|---|
| Validated cleaning per DIN EN ISO 13485 | |
| UDI verification per ISO/IEC 29158 | |
| Material testing per DIN EN ISO 7153 | |
| Sterile barrier systems ISO 11607-1/-2, EN 868-8, DIN 58953-9, MDR (EU) 2017/745 |
History
AS instruments have existed for 20 years now; the family-owned company looks back on a long history.