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Zpracovatel: Medipo EM, spole?nost s r. o., I?O 1851 0931, Ing. Vladimír Vejrosta Pracovník ?eského normaliza?ního institutu: Ing. Zdeněk Ku?era
Haemodialysers, haemofilters and haemoconcentrators
Zpracovatel: Medipo EM, spole?nost s. r. o., ICO 18510931, Věra Krchňákova Pracovník ?eského normaliza?ního institutu: Ing. Zdeněk Ku?era
本标准适用于仅使用一次的血液透析器，包括平行板型、蟠管型与空心纤维型之设计，同时也适用于仅使用一次的血液过滤器及血液浓缩器。本标准并不规定以上器材所用的材料，生物适合性测试的方法，灭菌确效的测试方法，致热源性的测试法，及一些功能特性。本标准不适用于下列设
Haemodialysers,hasmofilters and haemoconcentrators
Esta norma tiene por objeto establecer los requisitos que deben cumplir los hemo-dializadores, hemofiltros y hemoconcentradores (de fibras capilares
Diese Europ?ische Norm legt Anforderungen fest für sterile H?modlalysatoren, H?mod1af1lter, H?mofllter, H?mokonzentratoren und extrakorporale
Haemodialysers,haemodiafilters,haemofilters,haemoconcentrators and their extracorporeal circuits
Diese Internationale Norm legt Anforderungen an Hamodialysatoren, Hamodiafilter, Hamofilter und Hamokonzentratoren, nachstehend zusammenfassend als
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
이 표준은 본체에서 모두 “기기”로 기술되는, 혈액 투석기, 혈액 투석여과기, 혈액 여과기
Cardiovascular implants and extracorporeal systems－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Haemodialysers, haemofilters and haemoconcentrators
本标准规定了在人体上使用的血液透析器，血液透析滤过器，血液滤过器和血液浓缩器的技术要求，在本文中涉及的“器件”特指上述产品。 本标准不适用于： ——体外循环血液管路； ——血浆分离器； ——血液灌注装置； ——血管通路装置； ——血泵； ——体外循环血液管路的压力监测器 ——空气监测
Cardiovascular implants and artificial organs.Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Cardiovascular implants and artificial organs ?Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively
Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators for use in humans
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators, hereinafter collectively
Cardiovascular implants and artificial organs-Hemodialyzers,hemodiafilters,hemofilters,and hemoconcentrators
Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
La présente Norme internationale spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Haemodialysers, haemofilters and haemoconcentrators
この規格は，人に用いる血液透析器，血液透析ろ(濾)過器，血液ろ(濾)過器及び血液濃縮器(以下，機器という。)の要求事項について規定する。ただし，次の機器には適用しない
Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
本标准规定了血液透析、血液透析滤过和血液滤过设备的术语和定义、分类与标记、要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存。 本标准适用于血液透析、血液透析滤过和血液滤过设备。 不适用于连续性肾脏替代治疗(CRRT)的设备
Haemodialysis、haemodiafiltration and haemofiltration equipment
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This International Standard specifies requirements for single-use extracorporeal blood circuit (hereafter referred to as "the device") and (integral
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Hemodialyzers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
Specifies requirements for the single-use extracorporeal blood circuit and (integral and non-integral) transducer protectors which are intended
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
이 표준은 혈액 투석기, 혈액 투석여과기, 혈액 여과기에 사용되는 일회용 체외 혈관 순환
Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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