標準號：SIS SS 87 511 06-1989
中文標準名稱：血液輸液器
英文標準名稱：Infusion sets for blood
發布日期：1989/9/13 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：This part of ISO 1135 specifies requirements for types of single-use transfusion sets for medical use in order to ensure com-patibility of use with containers for blood and blood com-ponents and intravenous catheters and cannulas.The materials and components of the sets are validated by various test methods (type tests) and, in addition, tests are performed for the release of lots of finished sets (lot tests).The manufacturer shali select appropriate test methods to com-ply with the requirements laid down in this part of ISO 1135.Secondary aims of this part of ISO 1135 are to providea) specifications relating to the quality and performance of materials used in transfusion sets;b) a unified presentation of terms and designations for transfusion sets.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence ?ver this part of ISO 1135.This part of ISO 1135 specifies requirements applicable to sterilized transfusion sets intended for single use and for a single patient only.