市售輸液套及塑膠注射筒水溶出物試驗之品質調查   全文下載

An Investigation on Water Extraction Test of Infusion Sets and Disposable Syringes in the Taiwan Area

為了解市售輸液套及塑膠注射筒之品質，本局委請臺北市政府衛生局、高雄市政府衛生局及臺灣省政府衛生處，於民國八十五年七月至八十六年九月間，至轄區各醫院診所抽取輸液套檢體及塑膠注射筒（附針）檢體，加上各縣市政府衛生局自行抽驗之同類案件檢體，共計輸液套37件，塑膠注射筒（附針）41件。分別參照日本醫療用具之規格基準解說「用後丟棄式輸血套及輸液套基準」及中國國家標準CNS 9640「醫療用塑膠注射筒」記載之方法，進行水溶出物試驗（包括外觀、pH值、重金屬試驗、高錳酸鉀還原性物質試驗及蒸發殘留物試驗五項）。測試結果，塑膠注射筒（附針）均合格，輸液套不合格者1件，佔輸液套總件數之2.70%。不合格之檢體為國產品，不合格之項目為高錳酸鉀還原性物質試驗。概括而言，市售輸液套及塑膠注射筒（附針）之水溶出物試驗結果尚可。

During a period from May 1996 to September 1997, thirty-seven infusion sets and forty-one disposable syringes, with and without needles, were collected from different public and private hospitals/clinics of Taiwan.Water extraction tests were performed by using methods described in the Notification No. 42, published by the Minister of Health and Welfare of Japan (1978) and the Chinese National Standard 9640 (1984) respectively.The results showed that only one sample of the infusion sets did not comply with the acceptable standards.