市售外科手術用橡膠手套水密性及張力強度之品質檢測

為了解市售外科手術手套之品質及增進本署研究能量，本署曾於102年4至11月間，至醫療器材經銷商抽測市售手術用手套檢體。本次抽測第一類型手套（天然乳膠材質）9件，第二類型手套（合成橡膠材質）1件，總計共10件。參照99年9月30日署授食字第0991612765號公告之「含粉手術用手套」醫療器材臨床前測試基準、國際標準ISO 10282、ASTM D3577與EN 455進行水密性試驗及張力強度試驗。在水密性實驗部分，ISO 10282、ASTM D3577及EN 455三種標準檢測方法皆相同，本署與國內廠商共同設計開發符合上述標準的“手套水密性試驗機”進行檢測。而在張力強度試驗部分，上述三種標準在試片尺寸、允收標準及檢測流程上皆有差異。經實測評估後，因ASTM D3577在張力強度評估上較為全面，故本計劃選用其為檢測方法與評估依據，以進行市售產品檢測。檢測結果: 10件市售檢體在水密性試驗部分，洩漏數均達到此三種標準之要求。而在張力強度試驗部分，第一類型手套（9件）各測試結果之中位數分布範圍如下：破裂時張力強度21至30 MPa，伸長率666至827 %，特定伸長率張力強度2.8至9.7 MPa。第二類型手套（1件）測試結果之中位數如下：破裂時張力強度達19 MPa，伸長率832 %，特定伸長率張力強度3.4 MPa。本測試調查結果，可供行政管理單位作為市售品質調查與管理之參考依據。

關鍵字

手術手套；水密性試驗；張力強度

並列摘要

In order to ascertain the quality of marketed surgical rubber gloves, ten samples were collected from medical supplies stores (9 samples of type 1 gloves, natural rubber latex; 1 sample of type 2 gloves, elastomeric materials) in Taiwan from April to November 2013. The tensile strength test and watertightness test according to ISO 10282, ASTM D3577, EN 455 and ＂Guidance for testing of powdered surgeon’s gloves in pre-clinical trials＂ announced by TFDA. The tensile strength test method of ASTM D3577 was chosen after evaluation compared to ISO 10282 and EN 455. The results indicated that all samples passed watertightness test. In tensile strength test, the range of median of tensile strength results of the type1 gloves were from 21 to 30 MPa, elongations were from 666 to 827 %, stress at 500 % elongation were from 2.8 to 9.7 MPa. The median of tensile strength of type 2 gloves was 19 MPa, elongation is 832 %, and stress at 500 % elongation was 3.4 MPa. These results were provided to the management as an administrative reference.

並列關鍵字

surgical rubber gloves ； watertightness ； tensile strength

國際替代計量

市售外科手術用橡膠手套水密性及張力強度之品質檢測

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