Version December 2023
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.
KLS Martin SE & Co. KG
Kolbinger Str. 10
78570 Mühlheim an der Donau
KLS Martin SE & Co. KG
KLS Martin Platz 1
78532 Tuttlingen
KLS Martin SE & Co. KG
Am Flughafen 18
79108 Freiburg im Breisgau
KLS Martin Malaysia Sdn Bdh
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 and dental instruments only approved materials are to be used.
These are listed in the following standards and are mandatory for the respective manufacturer:
Deviations from the above mentioned standards must be documented and released in the specific
product drawing. Forged parts have to be free from folds, voids and discontinuities.
The hardness ofvthe 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 30 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 priority.
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:
1. according to currently valid drawing,
2. according to currently valid document “D00000000600 – WI Specifications for surface finish of surgical & dental instruments” or
3. depending on geometry, if 1 or 2 is not possible. Must be documented in technical drawing (see 1)
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, “D00000000600 – WI Specifications for surface finish of surgical & dental instruments” must be followed.
General:
All instruments must be delivered free of oil residues from production, 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 areas, joint areas and moveable parts 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:
Locks/Ratchets must be clean and uniformly pronounced over the entire functional profile. The ratchet must not release automatically when closed.
Working ends/tips:
Working ends must be functional according to the intended use. Tooth profiles are burr-free and evenly symmetrical down to the tooth base, must fit exactly into each other and must not hook in any position. The complete instrument is manufactured in a formally correct and coherent manner.
Springs:
The spring force or pressure must be uniform and sufficient for resetting the instrument.
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.
Instruments should be packed in such way that they will not be damaged during delivery and that they can be identified on basis of the current drawing and components that pose a risk of injury are appropriately covered and protected.
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