Technical category

Sterilisation for medical devices

38 Companies in this category

Sterile does not mean low in germs but statistically assured: devices placed on the market as sterile require a sterility assurance level of one in a million. This is not achieved by testing the finished product — sterility cannot be inspected in — but through a validated process and knowledge of the initial bioburden.

Three methods share the field, and each rules out materials. Steam to ISO 17665 is inexpensive, leaves no residue and suits many metals and high-performance polymers — but not electronics or temperature-sensitive plastics. Ethylene oxide to ISO 11135 works at low temperature but requires degassing times and assessment of residues. Gamma and electron beam to ISO 11137 is fast and can be applied in the final packaging, but embrittles some plastics and discolours others.

Packaging is inseparable from this: the sterile barrier system to ISO 11607 is part of the device, not an accessory, and is validated with it — including seal strength, transport simulation and ageing. The providers listed here range from contract sterilisation through validation services to operations handling processing and reprocessing.

Companies in this category

12 of 38

Service provider

Nanofilm AM Germany GmbH

Augsburg, DE

Contract coating and surface modification: DLC coatings axyprotect® and axyprotect® MED for implants and instruments, axynit® ion implantation, patented plasmaimpax® process — ISO 9001 and ISO 13485, part of the Nanofilm Group.

CoatingSterilisationTitanium

ISO 13485 · ISO 9001

Supplier

PROMOTEC-Medizintechnik GmbH

Blankenfelde-Mahlow, DE

Service provider from the greater Berlin area for the production, packaging and sterilisation of customer-specific medical devices — over 120 product types on behalf of customers, packaging in an ISO Class 7 cleanroom.

SterilisationPackagingPlasticsISO 14644-1 Class 7

Manufacturer

KARL STORZ SE & Co. KG

Tuttlingen, DE

Welcome to the world of endoscopy - Discover the innovative medical solutions from KARL STORZ. | KARL STORZ | Germany

SterilisationTitanium

ISO 13485 · ISO 9001 · MDSAP

Manufacturer

Stoma / Storz am Mark GmbH

Emmingen-Liptingen, DE

Dental instruments made in Germany since 1919: the stoma® range for diagnostics, conservative treatment, endodontics, periodontology, surgery, implantology, osteosynthesis and prosthetics, together with suture material — from the dental man

MachiningSterilisationTitanium

ISO 13485

Manufacturer

AS Medizintechnik GmbH

Tuttlingen, DE

Surgical instruments and the asipco® sterilisation container system from Tuttlingen — over 20,000 standard and special instruments, more than 300 trading partners worldwide, repair service and training.

CoatingLaser ProcessingTitanium

ISO 13485

Manufacturerchecked 10.09.2026

mebamed Medizintechnik GmbH

Meersburg-Baitenhausen, DE

Manufacturer of surgical and dental instruments from Meersburg on Lake Constance: over 22,000 basic instruments plus special instruments, certified to DIN EN ISO 13485.

SterilisationStainless Steel

ISO 13485

Supplier

Kunststoff Christel GmbH & Co. KG

Bad Dürrheim, DE

Kunststoff Christel is a medium-sized family business and at the same time a globally active manufacturer for multi-component injection moulding, assembly and toolmaking. Our production for medical technology achieves with our …

Injection MouldingCoatingPlasticsISO 14644-1 Class 7

ISO 13485 · ISO 9001 · ISO 14001