T-CVDA 26-2024 兽用腹腔可吸收防粘连凝胶

1 ICS 11.220 B 42 T/CVDA 团体标准 T/CVDA 26-2024 兽用腹腔可吸收防粘连凝胶 Veterinary peritoneal anti -adhesion gel 2024-12-30 发布 2025 -01-01 实施中国兽药协会发布全国团体标准信息平台 2 目录前言................................ ................................ ........ 4 1.范围................................ ................................ .......... 5 2. 规范性引用文件 ................................ ............................... 5 3. 术语和定义 ................................ ................................ ... 5 3.1防粘连凝胶 Antiadhesion gel ................................ .............. 5 3.2腹腔粘连 Abdominal Adhesions ................................ ........... 5 4. 缩略语................................ ................................ ....... 6 5. 性能指标 ................................ ................................ ..... 6 5.1材料................................ ................................ ..... 5 5.2外观................................ ................................ ..... 5 5.3装量................................ ................................ ..... 6 5.4凝胶PH值................................ ................................ 6 5.5 撕裂强度 ................................ ................................ 6 5.6重金属含量 ................................ ............................... 6 5.7硫酸盐灰分 ................................ ............................... 6 5.8溶剂残留量 ................................ ............................... 6 5.9组织粘附强度 ................................ ............................. 6 5.10成胶后稳定性 ................................ ............................ 7 5.11无菌................................ ................................ .... 7 5.12内毒素................................ ................................ .. 7 5.13细胞毒性 ................................ ................................ 7 5.14皮内反应 ................................ ................................ 7 5.15急性全身毒性 ................................ ............................ 7 5.16亚慢性毒性 ................................ .............................. 7 5.17植入试验 ................................ ................................ 7 6.检验方法 ................................ ................................ ...... 7 6.1 材料 ................................ ................................ .... 7 6.2外观................................ ................................ ..... 7 6.4凝胶PH值................................ ................................ 8 6.5 撕裂强度 ................................ ................................ 8 6.6重金属含量 ................................ ............................... 8 6.7硫酸盐灰分 ................................ ............................... 8 6.8溶剂残留量 ................................ ............................... 8 6.9组织粘附强度 ................................ ............................. 8 6.10成胶后稳定性 ................................ ............................ 8 6.11无菌................................ ................................ .... 8 6.12内毒素................................ ................................ .. 8 6.13细胞毒性 ................................ ................................ 8 6.14皮内反应 ................................ ................................ 9 6.15急性全身毒性 ................................ ............................ 9 6.16亚慢性毒性 ................................ .............................. 9 6.17植入试验 ................................ ................................ 9 全国团体标准信息平台 3 7.检验规则 ................................ ................................ ...... 9 7.1 抽样方法和数量 ................................ .......................... 9 7.2 出厂检验 ................................ ................................ 9 7.3 复核检查 ................................ ................................ 9 7.4 判定规则 ..........................