ISO/TC 170 - Surgical instruments

ISO 7153-1:2016 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 ISO 7153-1:2016 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.

Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

Specification of basic requirements for as well physical characteristics as workmanship, of the steel grades used and heat treatment of component parts, excluding rivets, screws and parts manufactured of material grade M.

This standard deals with materials, heat treatment and hardness of component parts, corrosion resistance, workmanship and cutting ability of scissors and shears used in the surgery and defines the test methods.

Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.

This second edition cancels and replaces the first edition (ISO 7153-1:1983): it has been extended to include dental instruments. Contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopaedic surgery. It takes into account steel grades and chemical compositions.