General Chapters | 合法醫療器材資訊網

MetricSize(GaugeNo.)LimitsonNeedleAttachment.AbsorbableCollagenSuture,NonabsorbableandSyntheticAbsorbableSutures,USPSize,Average(inkgf) ...

Procedure— Clamp each of 5 sutures in the tensilometer so that the needle is in the fixed clamp with all of the swaged portion exposed and in line with the direction of force applied to the suture by the moving clamp. Determine the force required to detach the suture from the needle. In the case of Standard Needle Attachment, the suture may break without needle detachment. Standard Needle Attachment— The requirements are met if neither the average of the 5 values nor any individual value is less than the limit given for the designated size in Table 1[1].

Table 1. Standard Needle Attachment for Absorbable and Nonabsorbable Sutures

Metric Size (Gauge No.) Limits on Needle Attachment ...

Nonabsorbable Surgical Suture | 合法醫療器材資訊網

USP Monographs | 合法醫療器材資訊網

» Absorbable Surgical Suture is a sterile, flexible strand prepared from collagen derived from healthy mammals, or from a synthetic polymer. Suture prepared from ... Read More

USP Monographs | 合法醫療器材資訊網

» Nonabsorbable Surgical Suture is a flexible strand of material that is suitably resistant to the action of living mammalian tissue. It may be in either monofilament ... Read More

Surgical suture | 合法醫療器材資訊網

Surgical suture is a · Eyed or reusable needles with holes (called eyes), which are supplied separate from their suture thread, are often used for suture. · The ski and ... Read More

General Chapters | 合法醫療器材資訊網

Metric Size (Gauge No.) Limits on Needle Attachment. Absorbable Collagen Suture, Nonabsorbable and Synthetic Absorbable Sutures, USP Size, Average (in kgf) ... Read More

Surgical Sutures | 合法醫療器材資訊網

2003年6月3日 — Surgical Sutures; Guidance for Industry and FDA” dated December 19, 2002. ... If your suture does not meet all USP requirements, the labeling ... Read More

usp suture sizes chart | 合法醫療器材資訊網

Surgical Sutures and ligatures are available in a number of sizes. Sutures are classified into different sizes based on the diameter of the thread. United States ... Read More

USP-41-tensile-strength-table | 合法醫療器材資訊網

2018年8月15日 — USP 41. Official Monographs / Suture 3901. Chromatographic system. (See Chromatography (621), System Suitability.) Mode: LC. Detector: UV ... Read More

相關資訊整理

General Chapters | 合法醫療器材資訊網

Nonabsorbable Surgical Suture | 合法醫療器材資訊網

USP Monographs | 合法醫療器材資訊網

USP Monographs | 合法醫療器材資訊網

Surgical suture | 合法醫療器材資訊網

General Chapters | 合法醫療器材資訊網

Surgical Sutures | 合法醫療器材資訊網

usp suture sizes chart | 合法醫療器材資訊網

USP-41-tensile-strength-table | 合法醫療器材資訊網

【“蓋那客”尿失禁手術用懸吊帶喜客系統】許可證字號:衛署醫器輸字第017803號

【“愛惜康”愛喜龍加強型可彎式電動腔鏡直線型切割縫合器】許可證字號:衛部醫器輸字第027964號

【“愛惜康”愛喜龍可彎式電動腔鏡直線型切割縫合器】許可證字號:衛署醫器輸字第024846號

【手術用諧波刀儀】許可證字號:衛署醫器輸字第008126號

【"壯生"單蕎可吸收性縫合線】許可證字號:衛署醫器輸字第017621號

【“愛惜康”思達飛外科用可吸收傷口吻合裝置】許可證字號:衛部醫器輸字第026490號

【“美康泰”迴路電極墊】許可證字號:衛署醫器輸字第021154號

【“柯惠”內視鏡自動手術弧形縫合釘】許可證字號:衛部醫器輸字第025788號

【“彼得斯外科”艾希爾不鏽鋼縫線】許可證字號:衛署醫器輸字第020489號

【“舒柔醫德”齊隆不可吸收外科縫合線】許可證字號:衛部醫器輸字第028203號

【“柯惠”易瑞司射頻消融系統及其配件】許可證字號:衛部醫器輸字第025761號

【“柯惠”彎型端對端自動縫合器】許可證字號:衛部醫器陸輸字第000610號

【外科用內植膜】許可證字號:衛署醫器輸字第006675號

【“愛惜康”哈默尼克新尼巨器械】許可證字號:衛署醫器輸字第019730號

【“柯惠” 複發式內視鏡胸腹自動縫合器及縫合釘】許可證字號:衛署醫器輸字第010682號

【台塑生醫“體健儀”-生理資訊紀錄系統】許可證字號:衛部醫器製字第006364號

【"得吉康" 手動式骨科手術器械 (未滅菌)】許可證字號:衛部醫器輸壹字第016610號

【"嘉霖"手動可調整式病床(未滅菌)】許可證字號:衛署醫器製壹字第003964號

【"思凱"牙科治療椅及其附件 (未滅菌)】許可證字號:衛部醫器輸壹字第014845號

【“巴德”艾克-佛斯氣球擴張導管】許可證字號:衛署醫器輸字第019296號

【“優美克”妮傲西斯雷射儀】許可證字號:衛署醫器輸字第023697號

【"善德"動靜脈瘻管針】許可證字號:衛署醫器製字第000875號

【曼斯特救急絆(未滅菌)】許可證字號:衛部醫器製壹字第004788號

【“愛爾康”全涵氧散光日拋隱形眼鏡】許可證字號:衛部醫器輸字第033957號

【孕適知快速驗孕試劑系列】許可證字號:衛署醫器製字第002354號

【“史得勞曼”洛新骨內植體(骨高度)】許可證字號:衛部醫器輸字第026962號

【德曼遜敏斯特心肌肌鈣蛋白I弗列克斯試劑組】許可證字號:衛署醫器輸字第022747號

【"星歐"月拋非球面軟式隱形眼鏡】許可證字號:衛署醫器製字第004086號

【愛蒂康非動力式治療床墊 (未滅菌)】許可證字號:衛署醫器製壹字第002585號

【"安適"肢體裝具 (未滅菌)】許可證字號:衛部醫器輸壹字第015798號