What is ISO 18340 about?
ISO 18340 discusses trocar pins, trocar sleeves, and endo therapy devices for use with trocar sleeves for endoscopes. ISO 18340 outlines the design, testing, and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable.
ISO 18340 also specifies the design, testing, and labelling of endo therapy devices that are inserted through these trocar sleeves and are also universally interchangeable and reusable.
ISO 18340 specifies the minimum requirements to produce the products mentioned.
Who is ISO 18340 for?
ISO 18340 on endoscopes is useful for:
- Manufacturers of endoscopes
- Medical laboratories
- Regulatory authorities
Why should you use ISO 18340?
The trocar endo therapy device consists of two elements a trocar pin and a trocar sleeve to gain internal access and perform endoscopy. Trocar pin is an endoscopic element with a sharp pyramidal or conical point, typically assembled and used together with a compatible trocar sleeve filling its lumen that allows the introduction of this assembly, used to puncture body cavities. The trocar sleeve endoscopic element is used together with a trocar pin to create an artificial orifice for puncturing body cavities.
ISO 18340 guideline provides requirements for trocar pin and trocar sleeve, endo therapy device for use through a trocar sleeve, not dismountable endo therapy devices, Dismountable endo therapy devices, Endo therapy device with spring handle for use through a trocar sleeve, materials, and marking for endo therapy devices for use with trocar sleeves. This helps in improving the quality and proper assessment of trocar pins, trocar sleeves, and endo therapy devices for use with trocar sleeves. This helps in increasing the product’s life throughout the lifecycle.