ISO/TC 172/SC 5/WG 6 - Endoscopes

This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.

This document applies to rigid endoscopes designed for use in the practice of medicine. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded. It specifies a test method for determining the optical resolution of endoscopes. This document provides a measurement method for characterizing three aspects of the optical resolution of a rigid endoscope. Characteristic A is used to provide a simple measurement of the limiting resolution of the endoscope image. Characteristic B provides a measurement of low spatial frequency resolution and characterizes the sharpness, or contrast, of the endoscope image. Characteristic C provides a measurement of the spatial frequency response of the endoscope image.

This document defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. This document does not define general medical terms or other general terms. This document does not define terms that should be defined in other ISO 8600 (all parts).

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned.

This document applies to endoscopes designed for use in the practice of medicine. It specifies measurement requirements and describes two test methods for measuring the field of view and direction of view of endoscopes. Method A uses the distance from the distal window to calculate the field of view. Method B uses the distance from the entrance pupil. Other test methods can be used if they obtain equivalent results.

ISO/TS 18339:2015 specifies the design of eyepiece cap and light guide connector of an endoscope to enable the combination of products from different manufacturers. The products intended only for limited combination are out of the scope. It is a mechanical connection; it might not generate best results, but it allows the user to be able to work. ISO/TS 18339:2015 supports manufacturers of components in the design of interfaces.

ISO 8600-1:2015 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

ISO 8600-2:2015 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy.

ISO 8600-7:2012 specifies requirements for medical endoscopes, either flexible or rigid with a bending section, of water-resistant type.

ISO/TS 18340:2015 specifies the design, testing and labelling of universal interchangeable and reusable trocar sleeves and trocar pins and of endotherapy devices which are inserted through these trocar sleeves. ISO/TS 18340:2015 represents the minimum requirements for the production of the products mentioned.

ISO 8600-4:2014 specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.

ISO 8600-1:2013 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

ISO 8600-1:2005 defines terms and gives requirements for endoscopes and endotherapy devices used in the practice of medicine.

ISO 8600-5:2005 specifies a test method for determining the optical resolution of rigid endoscopes with optics designed for use in the practice of medicine for type testing. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded.

ISO 8600-6:2005 defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area.