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FDA食品级TPE 88A, 食品接触的合规性, 医疗/护理用品, 生物兼容性, ISO 10993 Part 5, USP 第VI类

 

Mediprene® 500484M

热塑性弹性体

ELASTO

 

Technical Data

 

产品说明

ELASTO have developed a range of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes.

 

The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimize plunger movement for accurate dosage control and ease of injection.

 

Regulatory compliance

Originating from medical raw materials with high biocompatibility status and compounded under clean conditions, Mediprene TPEs are the material of choice for medical customers who want to maximize the probability that their devices will pass relevant medical tests.

 

The raw materials in these compounds comply with food contact norms like FDA 21CFR and 2011/10 EC. All polymers used have passed tests according to USP class VI and the paraffinic oil has passed the USP Mineral Oil NSF H1, reg 125038 and also the European Pharmacopeia, liquid paraffin.

 

Mediprene TPEs are latex free, which reduces the risk of allergic reactions. Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI.

 

总体

 

材料状态 • 已商用：当前有效

•  Processing - TPE Problem Solving (English)

资料 1 •  Processing Guide - Adhesion (English)

•  Technical Datasheet (English)

•  TPE Processing Guide (English)

搜索 UL 黄卡 •  ELASTO

供货地区 • 欧洲 • 亚太地区

特性 • 生物兼容性 • 食品接触的合规性

用途 • 医疗/护理用品

机构评级 • EU 2011/10/EC • ISO 10993 Part 5

• FDA 未评级 • USP 第VI类

外观 • 半透明 • 可用颜色

加工方法 • 挤出 • 注射成型

物理性能 额定值单位制 测试方法

比重 0.880g/cm³ ASTM D792

熔流率（熔体流动速率） (190°C/2.16 kg) 1.0g/10 min ASTM D1238

机械性能 额定值单位制 测试方法

抗张强度 ASTM D638

-- 9.90MPa

100% 应变 1.20MPa

300% 应变 1.90MPa

伸长率 (断裂) 800% ASTM D638

弹性体 额定值单位制 测试方法

撕裂强度 18.0kN/m ASTM D624

硬度 额定值单位制 测试方法

肖氏硬度 (邵氏 A, 4.00 mm) 48 ASTM D2240

注射 额定值单位制

料筒后部温度 180 到 220°C

料筒中部温度 180 到 220°C

料筒前部温度 180 到 220°C

模具温度 20.0 到 50.0°C

 

 

Mediprene® 500484M

热塑性弹性体

ELASTO

挤出 额定值单位制

料筒1区温度 150 到 210°C

料筒2区温度 150 到 210°C

料筒3区温度 150 到 210°C

料筒4区温度 150 到 210°C

料筒5区温度 150 到 210°C

 

 

 

 

 

 

 

医疗级ISO 10993 热塑性弹性体TPE ,医疗级ISO 10993塑胶原料TPE Mediprene® 500484M是东莞市双帮塑胶原料有限公司常年销售的塑料，因为塑料价格行情每天都有新变化前天的报价不等于今天的报价。本公司销售的所有原料保证是原厂原包,随料可以提供生产厂商提供的物性表、SGS报告，COA原料出厂报告,REACH报告,SVHC报告,UL黄卡,提供原料注塑加工工程中可能出现的各种异常现象解决方法，塑料牌号太多，本网站没有提供的本公司也有代理，详情请咨询本公司相关业务人员0769-87795123 

13549213581 肖生