T/CI 077-2022 Active Group standards

T/CI 077-2022 Disposable sterile hemostatic clip usage guidelines

Publish Date: 2022-09-26 Implement Date: 2022-09-26 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CI 077-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2022-09-26

Implement Date: 2022-09-26

Pages: 9 pages

Scope

Scope: This document specifies the structure, model marking, usage conditions, precautions before use, operating procedures, notes, markings, packaging, transportation, and storage of disposable sterile hemostatic clips. This document applies to the use of disposable sterile hemostatic clips (hereinafter referred to as "hemostatic clips") for mechanical hemostasis during minimally invasive surgery in natural cavities when upper and lower gastrointestinal bleeding is caused by non-varicose veins. Main technical content: 4. Use Conditions 4.1 The hemostatic clips shall be sterilized by ethylene oxide gas and are intended for single use only. 4.2 The hemostatic clips shall be used with endoscopes such as gastroscopes and colonoscopes with a biopsy channel ≥ 2.8 mm in diameter. 4.3 Before release, the clamping plates should not be opened or closed more than five times, so that the hemostatic clips can be repositioned and clamped at the lesion site. 5. Precautions Before Use 5.1 The hemostatic clips may cause separation or damage to the clamping part and the delivery part when passing through a curved biopsy channel, and there may be a potential risk of twisting or damage. If this occurs, the clips shall not be used. 5.2 Applying axial force to the clamped clamping part may cause separation of the clamping part from the delivery part and possible twisting or damage to the delivery part. If this occurs, the clips shall not be used. 5.3 When the endoscope is too tilted for the instrument to pass through, the endoscope needs to be straightened or aligned to allow the instrument to pass through. After passing through, the endoscope should be restored to its original state for treatment. If this occurs, the clips shall not be used. 5.4 The hemostatic clips are disposable sterile medical device products and are supplied in a sterile state. Before use, they should be carefully inspected to ensure that the sterile packaging of the device itself has not been damaged during tra