BSI - BS EN ISO 7153-1 - TC
Tracked Changes (Redline) - Surgical instruments — Materials Part 1: Metals
|Publication Date:||25 February 2020|
|ICS Code (Surgical instruments and materials):||11.040.30|
|ICS Code (Stainless steels):||77.140.20|
This part of ISO 7153 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While this part of ISO 7153 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
NOTE When selecting the grade of steel and the shape, dimensions and delivery conditions of the raw material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design of the instrument or the production facilities of the manufacturer, that are not covered by this part of ISO 7153. For this reason, it is not intended, nor is it possible, for the information given in this part of ISO 7153 to remove the decision-making responsibility from the instrument manufacturer for selecting an appropriate raw product with suitable properties; nor is it intended to preclude the use of other types of steel in the manufacture of instruments, such as the use of carbon steel for cutting instruments. International Standards for surgical instruments, when published, can be observed when making this decision as they may contain additional or new information to be taken into account when selecting appropriate steel grades.