NS-EN ISO 5840-3:2021由SCC 发布于 2021-02-16。
NS-EN ISO 5840-3:2021 心血管植入物 心脏瓣膜假体 第3部分:经导管技术植入的心脏瓣膜替代物 (ISO 5840-3:2021)的最新版本是哪一版?
最新版本是 NS-EN ISO 5840-3:2021 。
Full Description ADOPTED_FROM:EN ISO 5840-3:2021 This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
而且年轻患者植入生物假体要求植入物在体内持续稳定发挥作用的时间更长,但是实际问题是随着使用时间变长,植入物损耗引起并发症的可能性升高。 七、TAVR 其他并发症 除了上述提到的并发症外,我们还需要注意 TAVR 治疗中存在的一些“少数派”并发症。 1. ...
》118YY/T 1449.3—2016《心血管植入物人工心脏瓣膜第3部分:经导管植入式人工心脏瓣膜》119YY/T 1450—2016《载脂蛋白A-I测定试剂(盒)》120YY/T 1451—2016《脑利钠肽和氨基末端脑利钠肽前体检测试剂(盒)(定量标记免疫分析法)》121YY/T 1452—2016《干式血液细胞分析仪(离心法)》122YY/T 1454—2016《自我检测用体外诊断医疗器械基本要求...
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