m贴剂用医用胶带安全要求的探讨

1、1会计学m贴剂用医用胶带安全要求的探讨贴剂用医用胶带安全要求的探讨 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.织造布背衬橡胶膏离型纸离型纸/膜黑膏药织造布背衬织造布/无纺布背衬巴布膏离型纸织造布/无纺布背衬药膏/药垫离型纸橡胶膏剂狗皮膏（黑膏药）巴布剂药包式贴剂 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.安全性功能性- 毒理学

2、- 生物相容性- 工艺稳定性-追溯性-设计控制- 对材料/皮肤的粘性 - 灭菌方式的适应性舒适性- 顺应性/延展性/弹性- 皮肤残胶- 透气性 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.目前对医疗设备以及监控设备尚无限制 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.1. 氯化钴Cobalt dichloride( CoCl2 )

3、2. 重铬酸钠二水化合物Sodium dichromate3. 五氧化二砷Diarsenic pentaoxide(As2O5)4. 三氧化二砷Diarsenic trioxide(As2O3)5. 砷酸氢铅Lead hydrogen arsenate6. 三乙基砷酸酯Triethyl arsenate 7. 邻苯二甲酸二丁酯Dibutyl phthalate(DBP)8. 邻苯二甲酸二(2-乙基己)酯Bis (2-ethyl(hexyl)phthalate) (DEHP)9. 邻苯二甲酸丁苄酯Benzyl butyl phthalate(BBP)10. 蒽Anthracene11. 三丁基氧

4、化锡Bis(tributyltin)oxide(TBTO)12. 二甲苯麝香musk xylene13. 六溴环十二烷HBCDD14. 短链氯化石蜡SCCP15. 44-二氨基二苯甲烷4,4- Diaminodiphenylmethane 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.生物相容性测试医用产品必须通过国际标准ISO-10993，医疗设备的生物评估，第一部分：评估测试推荐的广泛的安全和效用评估过敏反应化学伤害 3M 2010. All Rights Reserved.Part 1: Evaluation and

5、 testingPart 2: Animal welfare requirementsPart 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityPart 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicityPart 6: Tests for local effects after implantationPart 7: Ethylene oxide sterilization res

6、idualsPart 8: Selection and qualification of reference materials for biological testsPart 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicityPart 12: Sample preparati

7、on and reference materialsPart 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloysPart 1

8、6: Toxicokinetic study design for degradation products and leachablesPart 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materialsPart 19: Physico-chemical, morphological and topographical characterization of materials Part 20: Principles and met

9、hods for immunotoxicology testing of medical devices 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 反 应记 分红斑和焦痂形成 无红斑0 极轻微红斑（勉强可见）1 红斑清晰2 中度红斑3 重度红斑（紫红色）至焦痂形成4水肿形成 无水肿0 极轻微水肿（勉强可见）1 水肿清晰（肿起，不超出区域边缘

10、）2 中度水肿（肿起约1mm）3 重度水肿（肿起超过1mm，并超出接触区）4刺激最高记分8 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.Short term: 0h,4h,24hLong term: 0h,24h,48h,72h 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved

11、. 3M 2010. All Rights Reserved.Contact dermatitis from adhesive plaster Reaction to ankle strapping Facial rash from rosin in makeup 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved.ConceptDevtFeasibilityPost-LaunchIdeaScale UpLau

12、nch市场计划项目计划DRS/DS 设计需要/设计标准DVF Plan设计确认计划HOQ质量屋第一层成本预估产品生命周期评估安全性EHS评估产品知识产权评估验证实验方法完成设计确认建立产品文件（原料标准、成品标准、检验方法、包装标准）建立工艺验证方案完成IQ/OQ实行PPU（产品和工艺理解）建立工艺标准HOQ质量屋第二层建立设计验证计划完成工艺验证市场确认完成设计验证更新成本评估 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Rights Reserved. 3M 2010. All Right

13、s Reserved.1. 氯化钴Cobalt dichloride( CoCl2 )2. 重铬酸钠二水化合物Sodium dichromate3. 五氧化二砷Diarsenic pentaoxide(As2O5)4. 三氧化二砷Diarsenic trioxide(As2O3)5. 砷酸氢铅Lead hydrogen arsenate6. 三乙基砷酸酯Triethyl arsenate 7. 邻苯二甲酸二丁酯Dibutyl phthalate(DBP)8. 邻苯二甲酸二(2-乙基己)酯Bis (2-ethyl(hexyl)phthalate) (DEHP)9. 邻苯二甲酸丁苄酯Benzyl butyl phthalate(BBP)10. 蒽Anthracene11. 三丁基氧化锡Bis(tributyltin)oxide(TBTO)12. 二甲苯麝香musk xylene13. 六溴环十二烷HBCDD14. 短链氯化石蜡SCCP15. 44-二氨基二苯甲烷4,4- Diaminodiphe