Version May 2020
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.
Karl Leibinger Medizintechnik GmbH & Co. KG
Kolbinger Str. 10
78570 Mühlheim an der Donau
Gebrüder Martin GmbH & Co. KG
KLS Martin Platz 1
KLS Martin GmbH + Co. KG
Am Flughafen 18
79108 Freiburg im Breisgau
Rudolf Buck GmbH
78570 Mühlheim an der Donau
KLS Martin Medical GmbH & Co. KG
KLS Martin Malaysia Sdn Bhd
No. 1193 Lorong Perindustrian Bukit Minyak 11,
Taman Perindustrian Bukit Minyak
14100 Simpang Ampat, Penang
EU | European Union
DIN | German institute for standardization
EN | European norm
ISO | International Organization for Standardization
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”, Medical Device Directive 93/42/EEC and German law for medical devices.
The requirements which are described here apply in addition to the product-related specifications and drawings.
For the manufacture of surgical instruments only approved materials are to be used.
These are listed in the DIN EN ISO 7153-1 “Surgical Instruments - Materials - Part 1: Metals” and are binding for the manufacturer or the specifications of the correponding 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.
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.
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.
Surface design in prioritized order:
To ensure the quality, the actual roughness value can be determined with a measurement. The measurement is made transverse to the brushing direction and must have a value of RA <= 0,5.
To ensure a consistent surface quality, Annex 1 of this document must be followed.
7. Important quality criteria
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 areas have to be oiled with medical paraffin oil.
Joints | Instruments with joints must have a steady gait. The joint areas have to be oiled with medical paraffin oil.
Box lock/ screw lock | The locks must be clean and smooth. No scratches, grooves or other damage must be visible. Screw and rivet connections must be processed in such a way that under no circumstances can they come loose independently during the entire life cycle of the instrument.
Ratchet lock | The teeth of the lock must be clean and even from the first to the last lock tooth. The ratchet must not release automatically when closed.
Working ends/ tips | The working ends must be fully functional for the respective purpose. Toothing must be burr-free and evenly symmetrical down to the root of the tooth. Cross teeth must fit exactly into each other, the teeth must not hook in any position, the complete instrument is symmetrical and laterally covering.
Springs | The spring force or spring pressure must be uniform.
Connections | All connections must be free of pores, cleanly processed and free of any damage.
Edges | All sharp edges must be broken unless they have a special function.
Shape | Asymmetrical shapes with regard to shape and dimensions, as well as distortion and unevenness (e.g. shafts) are not permitted.
The packaging for the delivery must be chosen in such a way to avoid any damages at the instruments during the transport.