의료 업계 최초의 비 DEHP 튜브 제품 중 하나 인 Tygon ND-100-65는 투석, 화학 요법 약물 전달 및 최소 침습 수술과 같은 응용 분야의 까다로운 과제를 해결하기 위해 공식화되었습니다. Tygon ND-100-65는 Tygon S-50-HL 의료 튜브를위한 DEHP가없는 대체품입니다.
형질: 열린 심장 수술에서 투석에 이르기까지 ND 100-65 튜브는 비 DEHP 가소성 물질이 필요한 의료 기기 제조업체를 위해 특별히 고안되었습니다. ND 100-65는 혈액 접촉 응용 분야의 성능 및 내구성에 대한 새로운 표준을 설정합니다. Saint-Gobain이 개발 한 고유 한 화학을 기반으로 TYGON ND 시리즈 튜브는 DEHP를 준수하는 화학 물질 (REACH)의 등록, 평가, 승인 및 제한을 위해 공식화되었습니다. 준수를 보장하기 위해 모든 개별 화합물 로트를 테스트하여 DEHP 수준이 <1000 ppm인지 확인합니다. 압출 공정 동안 개별 제품 치수는 인라인 마이크로 미터 및 컴퓨터 화 된 이미징 장비를 통한 오프라인 검증을 통해 유지 및 모니터링됩니다.
많은 의료용 튜브 요구 사항에 따라 ND-100-65 재료는 열, 전자 (RF) / 초음파, 용매 및 접착제 등의 방법을 사용하여 효과적으로 접착 / 용접 할 수 있습니다. 구성 요소를 선택할 때 고려해야 할 요소는 다음과 같습니다. 필요한 결합의 보안, 결합 할 재료의 무결성에 대한 영향 및 생체 적합성에 영향을 줄 수있는 잔류 물 또는 추출물의 존재. 본딩 절차를 사용하지 않을 때는 안전한 부착을 위해 기계적 클램프를 사용하는 것이 좋습니다.
생체 적합성 TYGON ND 100-65는 혈액 접촉 의료 기기 요구를 위해 특별히 개발 된 생체 적합성 비 DEHP 폴리머 재료로 만들어졌습니다. USP Class VI, ISO 10993, European Pharmacopoeia 3.1.1.2 및 European REACH 요구 사항을 충족합니다. 또한 비 용혈성 및 비 발열 성입니다.
일반적인 응용 분야 :
최소 침습 장치-혈액 및 IV 솔루션-투석 장비-상처 배수- 흡입 장비 -화학 요법 약물 전달-신장 투석 펌프-연동 펌프
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09/27/2022
Cole
Riverton, UT
Excellent product Will be buying from you all again
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