Shanghai Daoqin Plastics Co., Ltd.

        ◆ according to 《 Europe medical devices strip/profile 例》, 申请欧盟CE certification equipment manufacturing must combined ISO 13485-2016 standards

        ◆ combined supply can reduce plastics material use 户 风险

        ◆ 自 USA, Europe and 亚洲三 基 供 to will is full business provide 支持

        ◆ plan expand other 基

         Clariant plastics and coating material business day 宣布, its USA 缅因州路 easy 斯顿, 瑞典马尔默 and new add this factory already through for plastics medical devices manufacturing 商 严格 full new quality standards certification. this factory production MEVOPUR® Brand medical grade polymer modified material and color masterbatch.

         medical devices related new standards 陆续生效

         in 3 year new 规 渡期 inner, manufacturing can using/adopting upper 一版本 quality standards. in year year 初, new ISO 13485-2016 standards already comprehensive 生效. according to standards equipment certification will again by 受理.

         in addition, new 《 Europe medical devices strip/profile 例》(MDR)EU2017/745 and 《体 outer diagnosis strip/profile 例》(IVDR)EU2017/746 will 于2020 year 5 month 生效, market upper has product will to effect/influence.

         from technology 层面 看, ISO 13485仅 suitable for medical devices production 商, for/regarding it supply 商而言, ratio Clariant, this still is important standards, is this standards has reduce various 风险, effect/influence equipment property can, can property or combined property raw materials 变化 风险.

         more more use “ quality design ”(QbD) process/workflow need more more use material and its for safety property effect/influence. in addition, this requirements 首次开始靠拢 USA food product tube/pipe tube/pipe 理局(FDA)21 CFR第820部 separation 规定.

         Clariant plastics and coating material full medical and made business 链总监Steve Duckworth understanding 释道: “随 new standards 出台以 and and material and more tube/pipe related assessment day add strong/high, medical equipment and made company can can need heavy new assessment its 依赖 材 material and methods. it 们越 越 need 依托像 Clariant 一样 材 material supply 商, is this material supply for medical market separation understanding, has series can meet/satisfy market demand product. ”

        十 more year front, Clariant launch MEVOPUR® series product and 服务, in most large degree reduce medical devices in its cycle stage/phase 风险. R&D, production, sales and market 营销以 and 客户服务部门 full expert and 体客户密切 combined as, for material 进行预先 testing 并进行风险 assessment, is application combined 规, has for property color and function.

         this full property factory 几乎完 full force medical and made application, can ensure has MEVOPUR product formulation and 程序 一致 property and supply can property.

         factory Raw Materials according to for device and product usually requirements standards 进行预先 testing, this standards 包括: 《 USA 药典》USP <87> <88>(USP 6 grade) and ISO10993 standards, and USP <661.1>, 元素杂质指导原则ICHQ3D and and material packaging and equipment 《 Europe 药典》(EP)3.1章节. through and production 线 隔离, and 严格 变 more control process/workflow, can reduce 交叉污染 风险.

        尽 tube/pipe in and 审查原ISO13485 standards 期间积累 experience, however new ISO 13485-2016 standards for industry new 挑战.

        例如, 首次提出 for already electrical system 进行风险 assessment, 并开展适当 确认 or 验证操 as. make soft parts 并不直接 control process process/workflow, it 也经常会出现 in used for control Raw Materials or most product quality testing equipment in.

         Clariant already in full scope/range inner 启动 实施 new 版ISO13485-2016 standards plan, requirements Clariant medical business full quality and tube/pipe 专职经理 for 各 基 quality 经理 工 as 予以支持.

        亚太 区 production capacity

         is new ISO 13485-2016 medical standards, and for food contact material ISO22000 standards, new add Clariant can force in for product quality and decrease/reduce 风险予以 high degree 关注.

        该基 negative is China in inner 亚太 区 development and supply MEVOPUR product, covering resin in color and modified combined material and color masterbatch concentrated shrink material, this resin polypropylene (PP) (PP)以 and poly 苯硫(PPS) and poly 苯砜(PPSU) and other high temperature resin.

        鉴于MEVOPUR product combined formed 功, Clariant positive force will ISO13485-2016 standards to other 基.