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Terms / Definitions / Abbreviations

DIN | German Institute for Standardization
EN | European standard
ISO | International Organization for Standardization

ISO

General Requirements

The quality requirements described below are based on the market requirements, the normative requirements and the requirements of the Regulation (EU) Medical Device Regulation 2017/745.

The requirements described here are supplementary to the product-related specifications and drawings.

Dimensions and tolerances

The measuring methods for determining the basic dimensions are specified in DIN 96298 - 2 "Medical Instruments - Part 2:" Measurement methods for determining the basic dimensions ".

The specifications from the above standard are binding for determining the basic dimensions. Product-specific single standards or information on drawings are to be considered with priority.

Surface

  • Generally frosted Gem. currently valid drawing or depending on the geometry;
  • Roughness: RA <=0 .5 (measurement against the matting direction)
  • The general grinding direction of instruments is transverse.
  • Instruments with broad surfaces (e.g. bone levers, retractors, osteotomes) should be longitudinally provided that technically possible.
  • Special area / n acc. currently valid drawing with glass bead blasted surface with 40-70μ glass beads
  • The surface must be free of pores, cracks, scores, brews, scale residues, acidic fats and residues of grinding and polishing agents. No pores and / or open spots on soldering and / or welding connections. All sharp edges must be broken, unless they have to perform a special function.

General

All instruments are free of oil residues, stains, and traces of corrosion. Pores, cracks, grooves, burs, grinding and polishing residues as well as other impurities or damage to be delivered. The work ends must be fully functional for the intended use. The end and joint area should be oiled with medicinal paraffin oil.

Shape

Unbalanced shapes in terms of shape and dimensions, as well as distortion and unevenness (e.g. waves) are not allowed.

Lock

The teeth of the barrier must be clean and uniform from the start to the last ratchet tooth. The lock may not be released independently in any position.

Connections

Screw and rivet connections must be processed in such a way that under no circumstances can you break loose yourself.

Maul

The teeth must be fully developed and be equally large and symmetrical on both sides. Mouth edges are burr-free and evenly symmetrical except for the tooth base. Transverse teeth must fit exactly into one another, the teeth must not hook in any position, and the entire instrument is symmetrical and laterally opaque.

Spring

The spring force or the spring pressure must be carried out evenly.

Joint

Instruments with joints must show a steady gait.

Packaging

The packaging for the delivery of the goods must be selected so that no damage to
the instruments can occur during transport.

Packing

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