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題 名 | 市售橡膠製醫用手套針孔及水溶性蛋白含量試驗之品質調查=An Investigation on Pinhole Testing and Aqueous Extractable Protein Analysis of Rubber Surgical and Examination Gloves in Taiwan Market |
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作 者 | 吳亭瑤; 吳正寧; 馬秋舜; 杜培文; 鄒玫君; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 23 民94.09 |
頁 次 | 頁6-13 |
分類號 | 410.025 |
關鍵詞 | 針孔試驗; 水溶性蛋白含量試驗; 橡膠製醫用手套; Pinhole test; Rubber surgical gloves; Rubber examination gloves; Aqueous extractable protein test; |
語 文 | 中文(Chinese) |
中文摘要 | 為了解市售橡膠製醫用手套之品質,本局函請台北市、台北縣、 台中市、彰化縣、南投縣、高雄市及高雄縣各衛生局,於民國93 年3 月至5 月間至轄區之橡膠製醫用手套製造廠或代理商進行抽樣,抽得檢體手術手套4 件、醫檢手套19 件,共計23 件。參照CNS 12543 (1997 年)「外科手術用橡膠手套」(1)及ISO 11193-1:2002「Singleuse medical examination gloves ─ Part 1:Specification for gloves made from rubber latex or rubber solution」(2)進行針孔試驗,並以藥事法第75 條(3)及91 年7 月9 日衛署藥字第0910033378 號函(4)進行包裝標示檢查,另依據ASTM D5712-99「Standard Test Method for The Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method」(5)進行水溶性蛋白含量試驗。 檢驗結果:針孔試驗中,外科手術橡膠手套4 件均符合標準規定 (100.0%),醫檢橡膠手套5 件不符合(26.3%);水溶性蛋白含量試驗中,外科手術橡膠手套2 件不符合(50.0%),醫檢橡膠手套14 件不符合(73.7%);標示檢查部分,外科手術橡膠手套1 件不符合(25.0%),醫檢橡膠手套10 件不符合(52.6%),顯示業者對於自身產品,並未建立完善的品質管理系統,亟需加強改善。所有結果皆已發文各抽驗衛生局,請各衛生局針對轄區不符合之廠商,進行輔導改善。 |
英文摘要 | In order to ascertain the quality of commercialized surgical and examination rubber gloves in local market, 23 samples included 4 surgical rubber gloves and 19 examination gloves were collected from manufacturers, agents and hospitals, during the period from March to May 2004. The pinhole testings were carried out following the methods listed in CNS 12543:1997 "Surgical Rubber Gloves" and ISO 11193-1: 2002 "Single-use medical examination gloves - Part 1:Specification for gloves made from rubber latex or rubber solution". The aqueous extractable protein tests were conducted according to ASTM D5712-99 " Standard Test Method for The Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method". Inspection result showed that 4 samples of the surgical gloves were qualified (100.0%) in pinhole tests, 2 samples (50.0%) failed to meet the requirement mentioned in aqueous extractable protein tests, 1 sample (25.0%) violated the labeling regulation. 5 samples (26.3%) of the examination gloves failed tomeet the requirementmentioned in pinhole tests, 14 samples (73.7%) of examination gloves failed to meet the requirement mentioned in aqueous extractable protein tests, 10 samples (52.6%) violated the labeling regulation. |
本系統中英文摘要資訊取自各篇刊載內容。