ISO/TC 170 - Surgical instruments

This document defines terms for surgical instruments and their components.

This document specifies methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy.

This document defines test methods for surgical standard instruments. This document does not cover instruments for use on the central nervous system and on the central cardiovascular system.

This document specifies general requirements for staplers, including requirements for stapler classification, intended performance, design attributes, design evaluation, manufacturing, sterilization, packaging, information supplied by the manufacturer, and tests to demonstrate conformance with these requirements. This document is applicable to single-use staplers and reusable staplers. This document only applies to instruments that use staples.

This document defines terms related to staplers and their components. This document only applies to instruments that use staples. NOTE Commonly used forms of staples can be found in Figure 1.

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

This document specifies general requirements and corresponding test methods for a general range of non-cutting instruments in surgery.

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.

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.

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

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.

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.