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主会场：医疗器械—高分子2015年会暨国际医用耗材产业发展论坛 时间： 3月23日上午
Main Session：Medical Devices --- Macromolecule 2015 Annual Meeting and
International
Medical
Consumables Industry Development Forum Date: Mar. 23rd Morning
地点：宴会厅Grand Ballroom 主持人：黄爱贞秘书长 Huang Aizhen，Secretary-General
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3月23日
上午
Mar. 23rd
Morning
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8:30-8:45
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中国医疗器械行业协会领导讲话
China Association for
Medical Devices Industry Opening
Speech
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8:45-9:00
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上海医疗器械行业协会领导讲话
Shanghai Medical Instrument Trade
Association Opening Speech
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潘明荣
Pan Mingrong
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9:00-9:30
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高分子2014年工作报告
2014 CAMDIMMP Annual Report
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张宪淼
Zhang Xianmiao
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9:30—10:40
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医疗器械新法规实施后,产品注册与延续注册申报资料要求及审核要点
Introduction of
application material requirements and auditing key points of products which
register or extension register after the issue of new regulations of medical
devices.
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医疗器械技术审评中心
Center for Medical Device Evaluation of CFDA
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10:40-11:50
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医疗器械知识产权纠纷典型案例分析及知识产权战略布局
Analysis of typical
cases about medical device disputes over intellectual property rights and
intellectual property strategy layout.
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张伟波
Zhang Weibo
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日期
Date
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时间
Time
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主 题
Topic
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演讲嘉宾
Speaker
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会场一： 制造设备与医用原材料的发展与应用 时间：3月23日下午 Date: Mar. 23rd Afternoon
Session 1: Development
and Application of Manufacturing Equipment and Medical Raw Material
地 点：光大1号厅Hall No. 1 主持人： 黄忆美副总经理 Huang Yimei ，Vice-General
Manager
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3月23日
下午
Mar. 23rd
Afternoon
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13:30-15:20
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静脉留置针熔头工艺技术
Venous indwelling
needle fuse head process and technology
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Janzi Jacobsson
Håkan Wimark
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15:20-16:20
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聚碳酸酯在医疗器械的创新方案以及TPU材料在医疗导管和连接器上的应用
Innovation of
polycarbonate in medical devices and application of TPU materials in the
medical catheter and connector
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王良文
Wang Wenliang
李宪文
Daniel
Li
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16:20-17:00
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Tritan 共聚聚脂在医疗应用中的耐化学性优势
Chemical resistance
advantages of Tritan Copolyesters in medical application.
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钱钟钟
Qian
Zhongzhong
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17：00-17：40
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创新透明聚丙烯为一次性注射器行业带来多样化解决方案
Innovative clear PP brings
diversified solutions for disposable syringe industry
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李秉荣
Li Bingrong
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会场二：灭菌包装材料、工艺与验证及新技术发展 时间：3月23日下午 Date: Mar. 23rd Afternoon
Session 2: Sterilized packaging materials, process
& verification and the development of new technology
地点：光大9号厅Hall No. 9 主持人：秦蕾经理Qin Lei， Manager
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3月23日
下午
Mar. 23rd
Afternoon
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13:30-15:00
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最终灭菌医疗器械包装的国际标准更新及介绍
EN ISO 11607 &
ISO/TS 16775 Update - Terminally Sterilized Medical Devices.
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Michael
H. Scholla, Ph.D.
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15:00-16:20
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灭菌工艺（环氧乙烷，电子束）与验证介绍
Sterilization
processes (EO, Electron beam) and validation
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徐海英
Xu Haiying
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16：20-17：40
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灭菌包装方案与验证介绍
Sterilized packaging solution
and verification
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宋龙富
Song Longfu
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日期
Date
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时间
Time
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主 题
Topic
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演讲嘉宾
Speaker
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会场三：麻醉耗材、卫生敷料等产品的临床应用及研发 时间：3月23日下午 Date: Mar. 23rd Afternoon
Session 3: Clinical application and
development of anesthesia disposables, sanitary dressings and other products
地点：光大8号厅 Hall No. 8 主持人：胡庆国董事长 Hu Qingguo， Chairman
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3月23日
下午
Mar. 23rd
Afternoon
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13：30-14:40
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ISO 10993中致敏、刺激、细胞毒系列标准的更新情况介绍
The latest updates of
the standards of sensitization, irritation, cytotoxicity series in ISO10993
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刘成虎
Liu Chenghu
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14:40-16:10
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利用国际资源建立适合中国市场的产品研发体系
Take advantage of
international resources to establish production development system that
matches Chinese market
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Harry Hari
Carl
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16:10-17:40
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国内外麻醉科主流耗材的临床使用
Clinical use for main
consumptive material in Anesthesia Department
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董振明
Dong Zhenming
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会场一： 制造设备与医用原材料的发展与应用 时间：3月24日上午 Date: Mar. 24th Morning
Session 1: Development and application of manufacturing
equipment and medical consumables
地点：光大1号厅Hall No. 8 主持人：季跃相总经理 Ji Yuexiang， General Manager
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3月24日
上午
Mar. 24th
Morning
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8:30-10:30
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自动止液膜、疏水透气膜原理及其在三类高分子器械的应用和发展
Automatic check film,
hydrophobic breathable film theory and its application and development in medical
device field
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はら しんじ
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10:30-12:00
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生命科学趋势及医疗产品的领先注塑技术
Trends of life science
and advanced injection molding technology for medical products
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Markus Malleck
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会场二：灭菌包装材料、工艺与验证及新技术发展 时间：3月24日上午 Date: Mar. 24th Morning
Session 2: Sterilized packaging materials, process
& verification and the development of new technology
地点：光大9号厅Hall No.9 主持人：兰海总经理 Lan
hai，General Manager
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3月24日
上午
Mar. 24th
Morning
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8:30-10:00
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医疗临床单位对于灭菌包装的要求与常见问题
Requirements and FAQ of
sterilized packaging for clinical institutions
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巩玉秀
Gong Yuxiu
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10:00-12:00
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薄膜包装材料新技术与新应用介绍
New technologies and new applications of film
packaging materials
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Paavo Muhonen
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日期
Date
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时间
Time
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主 题
Topic
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演讲嘉宾
Speaker
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会场三：麻醉耗材、卫生敷料等产品的临床应用及研发 时间：3月24日上午 Date: Mar. 24th Morning
Session 3: Clinical
application and development of anesthesia disposables, sanitary dressings and
other products
地点：光大8号厅Hall No. 8 主持人：王辉Wang Hui，Chairman
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3月24日
上午
Mar. 24th
Morning
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8:30-10:30
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医疗器械临床试验统计学考虑
Statistical analysis
of clinical trials for medical devices
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李卫
Liwei
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10:30-12:00
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医用导管固定装置、储物罐、鼻氧管、一体式吸氧管、呼吸回路等产品在临床应用中常见问题
FAQ in clinical
applications about medical tube fixture, storage tanks, nasal oxygen tube,
integrated oxygen tube, breathing circuit, etc
；里米尼21·
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薛张纲
Xue Zhanggang
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会场一： 制造设备与医用原材料的发展与应用 时间：3月24日下午 Date: Mar. 24th Afternoon
Session 1: Development and application of manufacturing
equipment and medical consumables
地 点：光大1号厅Hall
No. 1 主持人：黄祥林总经理 Host: Huang Xianglin，General Manager
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3月24日
下午
Mar. 24th
Afternoon
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13:30-14:30
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国产输液器用玻璃纤维膜的替代设想及验证
Envision and
verification of the replacement of glass fiber membrane for infusion set
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安全福
An Quanfu
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14:30-15:30
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聚氨酯在输液器中的应用
The application of Polyurethane
in infusion set
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闫戈
Yan Ge
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15:30-16:30
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医用级有机硅材料新兴的法规要求与医疗器械市场
Emerging regulations
and medical device market of medical organic silicone material
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马小刚
Ma
Xiaogang
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16：30-17：30
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TOTM增塑医用PVC塑料的特性及应用
Characteristic
and application of PVC plasticized by TOTM
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陆峰
Lu Feng
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会场二：灭菌包装材料、工艺与验证及新技术发展 时间：3月24日下午 Date: Mar. 24th Afternoon
Session 2: Sterilized packaging materials, process
& verification and the development of new technology
地点：光大9号厅Hall No. 9 主持人：蒋广成 总经理Jiang Guangchen，General Manager
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3月24日
下午
Mar. 24th
Afternoon
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13：30-15:00
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欧盟最新法规动态及欧盟飞行检查要求和应对办法
The updated EU
regulation dynamics and EU unannounced inspection requirements and solution
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炼红文
Lian
Hongwen
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15:00-16:20
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灭菌包装相关质量管理体系介绍
Introduction of
relevant quality management system on sterilized packaging.
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李元春
Li Yuanchun
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16:20-17:40
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美国/欧盟法规和标准对风险管理与控制的要求
USA / EU regulations
and standards requirements for risk management and control
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孙芸
Sun Yun
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日期
Date
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时间
Time
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主 题
Topic
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演讲嘉宾
Speaker
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会场三：麻醉耗材、卫生敷料等产品的临床应用及研发 时间：3月24日下午 Date: Mar.24th Afternoon
Session 3: Clinical application and
development of anesthesia disposables, sanitary dressings and other products
地点：光大8号厅Hall No. 8 主持人：王国胜董事长Wang Guosheng，Chairman
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3月24日
下午
Mar. 24th
Afternoon
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13：30-15：00
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国际卫生敷料失禁、伤口、造口护理耗材产品的临床应用
Clinical applications
of international dressings consumables for incontinence, wound, and ostomy
care
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孟晓红
Meng Xiaohong
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15：00-16:30
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国内外疼痛科CT定位引导穿刺类耗材产品的临床应用
Clinical applications
of CT guided percutaneous puncture consumables in domestic and foreign
department of Pain Clinic
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杜冬萍
Du Dongping
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16:30-17:40
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输液治疗的风险
Infusion Therapy Risks
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Oliver Groenlund
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