Technical Terms of Delivery of Surgical Instrumetns

Version March 2019

1. Purpose / Involved companies

In this document the general requirements to surgical instruments of all companies of the KLS Martin Group are described in order to protect a homogeneous and reproducable quality of products. These requirements apply to all suppliers of the companies.

Gebrüder Martin GmbH & Co. KG
KLS Martin Platz 1
78532 Tuttlingen

Karl Leibinger Medizintechnik GmbH & Co. KG 
Kolbinger Str. 10 
78570 Mühlheim an der Donau 

KLS Martin GmbH + Co. KG
Am Flughafen 18,
79108 Freiburg im Breisgau

Rudolf Buck GmbH
Römerweg 9
78570 Mühlheim an der Donau

Stuckenbrock Medizintechnik GmbH
Lessingstraße 50
78532 Tuttlingen

2. Terms / Definitions / Abbreviations

DIN | German institute for standardization
EN | European norm
ISO | International Organization for Standardization

3. General requirements

The following described quality requirements are made up of the market demands, the normative requirements and as well as of the requirements from the EU regulation “Medical Device Regulations 2017/745”.

The requirements which are described here apply in addition to the product-related specifications and drawings.

4. Materials

For the manufacture of surgical instruments only approved materials are to be used.
These are listed either in the DIN EN ISO 7153-1 “Surgical Instruments - Materials - Part 1: Metals” or the specifications of the drawing apply. Forged parts have to be free from folds, voids and discontinuities.

The hardness of the instruments is to be carried out according to the drawing or if not specifically listed, according to DIN EN ISO 7153-1. The hardness test is to be carried out in accordance with the standards DIN EN ISO 6507-1, DIN EN ISO 6508-1 or DIN ISO 3738-1.

The work test certificates 3.1 according to DIN EN 10204 are to be archived 10 years after delivery.

5. Dimensions and tolerances

The measurement methods for determining the basic dimensions are defined in DIN 96298 - 2 „Medical Instruments - part 2: „Measuring methods for investigating the basic dimensions“. The specifications from the standard mentioned are binding for the determination of the basic dimensions. Product-specific individual standards or information on drawings must be considered with priorty.

6. Surface

Generally matted

  • according to currently valid drawing or
  • depending on geometry;
  • roughness: RA <= 0,5 (measurement contrary to the matting direction)
  • the general grindig direction for instruments is transverse
  • instruments with wide surfaces (e.g bone levers, retractors, osteotomes,…) must be used in the longitudinal direction, if technically possible

Special surface(s) according to currently valid drawing

  • on glass bead blasted surface with 40-70μ glass beads

7. Important quality criterias

General | All instruments must be delivered free of oil residues, stains, traces of corrosion, pores, cracks, grooves, burrs, grinding and polishing residues as well as other impurities and damages. The working ends must be fully functional for the respective purpose. The closing and joint area have to be oiled with medical paraffin oil.
The boil test shall be verified in accordance with DIN EN ISO 13402.

Surface(s) | The surface must be free of pores, cracks, grooves, burrs, acidic fats and of residues of grinding and polishing agents. No pores and/or open areas on soldered and/or welded joints shall be visible. All sharp edges must be broken unless they have a special function.

Forms | Asymetrical forms, regarding to form and dimensions, as well as distoration and unevenness (e.g. waves) are not permitted.

Jaw | The teeth must be fully pronounced, equally large and symmetrical on both sides. The jaw edges must be free of burrs and evenly symmetrical down to the root of the tooth. Cross teeth have to fit exactly into each other, the teeth must not hook in any position. The complete instrment should be symmetrical and covers the sides.

Lock | The toothing of the barrier has to be clean and pronounced from the start to the last barrier tooth. The barrier should be secured againt self-loosening in any position.

Joint | Instruments with joint have to show a steady gear.

Spring | The spring force or spring pressure has to be carried out steadily.

Connections | Screw and rivet connections have to be processed in such a way that the self-loosening is secured under any circumstances.

8. Packagings

The packaging for the delivery must be chosen in such a way to avoid any damages at the instruments during the transport.