This part of ISO 7153 specifies metals commonly used in the manufacture of the various types of standardized surgical instruments, including but not limited to those instruments used in general surgery, orthopedics and dentistry. While this part of ISO 7153 is not intended for surgical instruments used for specialized applications such as implantology and minimally invasive surgery, parts of it may be applicable to these instruments. NOTE When selecting the steel grade and the shape, dimensions and delivery conditions of the raw material for the manufacture of surgical instruments not considered in this part of ISO 7153, it is necessary to take into account factors such as the design of the instruments or the manufacturer's production facilities. For this reason, it is neither intended nor possible that the information contained in this part of ISO 7153 relieves the instrument manufacturer of the decision-making process for selecting an appropriate raw material with appropriate properties, nor is it intended to restrict the use of other types of steel in the manufacture of the instruments, such as the use of carbon steel for cutting instruments. International standards for surgical instruments, if published, may be considered when making this decision as they may contain additional or further information to be taken into account when selecting appropriate steel grades.
EN ISO 7153-1:2016 Referenced Document
ASTM B265-15 Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate*， 2024-04-20 Update
ASTM B348-13 Standard Specification for Titanium and Titanium Alloy Bars and Billets*， 2024-04-20 Update
ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments*， 2024-04-20 Update
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
EN 573-3:2013 Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products*， 2024-04-20 Update
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 13402:1995 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 18265:2003 Metallic materials - Conversion of hardness values
ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
ISO 5832-3:1996 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 6507-1:2005 Metallic materials - Vickers hardness test - Part 1: Test method
ISO 6508-1:2016 Metallic materials - Rockwell hardness test - Part 1: Test method
EN ISO 7153-1:2016 history
2016EN ISO 7153-1:2016 Surgical instruments - Materials - Part 1: Metals
2000EN ISO 7153-1:2000 Surgical Instruments - Metallic Materials - Part 1: Stainless Steel ISO 7153-1:1991; Including Amendment 1:1999