ISO 5838-1-2013 pdf free download.Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements.
5 Method of manufacture
Skeletal pins and wires shall be manufactured by a cold drawing or a cold working process. Welds are not permissible. If local heating is needed for re-shaping points made of stainless steel, this can only be permitted provided that the whole of the final product can be shown to satisfy the intergranular corrosion test according to ISO 3651-2.
6 Finish
The external surface finish shall be free from burs, scratches and other defects visible to the naked eye.
The products shall be appropriately treated to provide surface passivation.Special attention should be paid to screw threads, if applicable.
7 Sterilization
The requirements of ISO 14630:2012, Clause 9, shall apply.
8 Packaging
The requirements of ISO 14630:2012, Clause 10, shall apply.
9 Information supplied by the manufacturer
9.1 General
The requirements of ISO 14630:2012, Clause 11, apply together with the following particular requirement.
9.2 Instructions for use
The requirements of ISO 14630:2012, 11.3, apply, and shall include the following details when relevant:
a) the product name,
b) characteristic sizes,
c) material specification, and
d) the appropriate drill bit dimensional characteristics.
9.3 Marking on implant
The requirements of ISO 14630:2012, 11.5, apply, and shall include the following details when the
dimensions permit:
— the manufacturer’s name or trademark, and
— the batch code.
Additional markings could include length and diameter or cross-sectional size for skeletal pins.ISO 5838-1 pdf download.