1
关注
1242
浏览

Under what circumstances do environmentatests need to be carried out on medical electricalequipment?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:36

If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if the product performance and clinical effectare easily affected by environmental factors, the supporting data thatthe product can be used normally and stably in the correspondingenvironment shall be provided in the research data.If applicable, the related requirement of GB/T 14710 shouldbe specified in product technical requirement, and the test should beconducted according to requirement.


关于作者

问题动态

发布时间
2023-09-17 22:36
更新时间
2023-09-17 22:36
关注人数
1 人关注

相关问题

what aspects should beconsideredin the application materials?
什么是DOE
What is “metadata”?
DOE响应曲面设计分析: 弯曲Curve判断标准是什么?
How does FDA use the terms “static” and “dynamic” as they relate to record formats?
What are the requirements for adding models oraccessories in the Change of Permission Items?
What should be included in the research data ofactive medical devices service life?
What is the meaning of “Unit Quantity”?
What is an “audit trail”?
What is software core algorithm?

推荐内容

是否透析浓缩物所有型号、规格的产品均应进行 稳定性验证?
无源医疗器械发生变化时,何种情况需考虑对其安全性进行重新评价?
GB/T14233.1-2022实施后,延续注册过程中,是否可以保留原技术要求中环氧乙烷残留量检测所用的“比色法”?
产品在完成加速稳定性试验研究后,是否可以不限定产品的储存运输条件?
关于注册检批次的产品检验的问题?
上市的产品包括硬件和软件组件,如将软件组件做为独立软件进行注册,且预期用途与功能都不变的情况下,同品种临床评价中可以将原产品中的软件组件做为对比器械进行同品种对比吗?
关于建立自检实验室过程中,体系建立需要写风险管理文件,风险管理文件是按照ISO14971或YY0316风险管理要求进行吗?
骨科植入器械金属涂层的性能评价应关注哪些方面?
骨科植入医疗器械非临床研究中,若申报产品通过等同性测试以证明与已上市产品等同,是否一定要选择性能最差情形的样品进行性能研究?
ECMO产品动物试验评价指标包括哪些?