Shanghai Daoqin Plastics Co., Ltd.

        凯柏胶宝宣布, its thermoplastic M combined combined Germany engineering 师协会(VDI) 2019 year 7 month through suitable for medical grade grade plastics (MGP) 2017 准则 requirements.

         as is plastics manufacturing and use 户 参考 guide, VDI 2017 准则规定 from basic requirements to formulation property and positive tube/pipe and strip/profile 款, 每一款 combined MGP must meet/satisfy this requirements.

        20 材 material supply 商, use and machine 构共同 formed 立 准则委员会 (RA), force made medical grade grade plastics (MGP) most low general purpose standards.

        此 front, tube/pipe has USA food and product tube/pipe (FDA) 颁布 《药 product 主控文 parts (DMF)》以 and used for medical product (包括植入 material, outer diagnosis agent and material 包材)生 material versus property ISO 10993 standards, and will 于 2020 year 5 month 起生效 about/regarding medical product regulations MPV 2017/745, and USA front 尚无涉 and this important field/area polymer 明确准则 or standards.

        “VDI 2017 is medical grade grade plastics must meet/satisfy property can scope/range non important 第一步, it is medical grade grade plastics manufacturing and OEM and / or medical, made and outer product manufacturing between provide strong/high made property 指导准则, ”准则委员会 formed 员, 凯柏胶宝® medical product Oliver Kluge 说道. “ new 准则明确规定 各 材 material supply and its can selection scope/range, 以方便 its more 广泛 安排. ”

        VDI 2017 main/primary effect/influence is made medical grade grade plastics use raw materials and additives scope/range, this 意味 一 manufacturing must adjustment 他们 材 material formulation.

         new also utilizing 记录变 more control tube/pipe system, 掌控特定化 combined material formed separation can property, ensure combined material combined long use, 而无需 more 次进行昂贵 检查. VDI 2017 also 允许召回材 material using/adopting more long 渡期, is use 户保障 more more supply safety.

        “我们 thermoplastic M series medical grade grade thermoplastic property elastomer long 期以 一直符 combined suitable for medical grade grade plastics requirements, therefore 我们 需 provide more detailed specifications 信息即 can, ”Kluge table/sheet 示. “但我们 will 继续积极关注该准则 future 修订, from 而进一步 improves medical grade grade plastics safety property. ”

         in upper and regulations MPV 2017/745 背景 lower, VDI 2017 medical grade grade plastics 准则委员会 plan most in 2020 year for 该版本进行修订. 2019 year 7 month 初, in 柏林举行 about/regarding medical grade grade plastics VDI large upper, this sleeve/set already by 提出并进行 充 separation 讨论.

         product type 丰富并经 certification medical grade grade thermoplastic property elastomer

         has thermoplastic M series combined material 均不含 heavy metal, 乳胶, PVC and 邻苯二甲 acid salt, full in specialized production upper most high pure degree production formed.

        精心 selection various material already according to USP VI grade (第 88 章), ISO 10993-5(fine property), ISO 10993-10(皮 inner 刺激), ISO 10993-11(急 property full property) and ISO 10993-4(血 liquid versus property)进行 testing and certification. Raw Materials quality guaranteed also supply 商方面 for batch full can property. 凯柏胶宝® 材 material also combined REACH and RoHS 规定.

         in addition, thermoplastic 宝M product series also by FDA 《药 product 主控文 parts (DMF)》 in, formulation 变动都会 according to more control process/workflow 进行记录.

         is 进一步 ensure full new VDI 2017 准则, 凯柏胶宝® will manufacturing process/workflow covering in more control tube/pipe system in, and type combined material formulation will in more or notice rear and new formulation meanwhile 保留至 less 24 month. this is 保健, made 药, medical and diagnosis industry use thermoplastic property elastomer medical grade combined material provide most high standards quality control and supply safety 保障.

         full sleeve/set product series covering different hardness combined material, can use ring oxygen 乙烷(EtO), 蒸汽, γ 射线 or electronics and other methods light 松杀菌.

         remove optimization property and anti slip property standards combined material outer, also provide for polyester and polyamide (PA) and other technology thermoplastic property plastics tool has excellent bonding force product type type.

         thermoplastic M series combined material also can provide combined medical application in non important used for 目视检查 semi transparent and high transparency degree product, and application in type combined material and 特定化 combined material.