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市售及醫院用醫檢橡膠手套針孔試驗之品質調查

An Investigation on Pinhole Testing of Rubber Examination Gloves in Taiwan Market

摘要


為了解市售及醫院用醫檢橡膠手套之品質,本局函請台北台北縣、台中縣、彰化縣、雲林縣、嘉義縣、台南縣、高雄市及高雄縣各衛生局,於民國九十二年六月至八月間至轄區之醫檢橡膠手套製造廠、代理商或醫院進行抽樣,所抽得之檢體共計21件,其中國產4件,輸入12件,未標示國別5件。參照國際標準ISO 11193 「Single-use rubber examination gloves-Specification」(上標 (1))之方法,進行針孔試驗,依藥事法第七十五條(上標 (2))、衛生署八十二年三月二十三日衛署藥字第8224055號公告(上標 (3))及九十一年七月九日衛署藥字第○九一○○三三三七八號函(上標 (4))進行包裝標示檢查。檢驗結果:針孔試驗4件不合格(19.1%),輸入品3件,佔輸入件數比例25.0%,未標示國別1件,佔未標示國別比例20.0%;標示檢查部分則有13件不符合規定(61.9%)。顯示業者對於自身產品,並未建立完喜的品質管理系統,亟需加強改善。

並列摘要


In order to ascertain the quality of commercialized rubber examination gloves in local market, 21 samples were collected from manufacturers, agents and hospitals, during the period from June to August 2003. The pinhole testings were carried out following the methods listed in International Organization for Standardization No. 11193. The results showed that four samples (19.1%) failed to meet the requirement mentioned above. Thirteen samples (61.9%) violated the labeling regulation.

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