21 CFR 名词解释区别

秋红叶

21 FCR 803中 “Caused or contributed means that a death or serious injury was or may have been attributed to a medicaldevice, or that a medical device was or may have been a factor in a death or serious injury, includingevents occurring as a result of1) Failure,(2) Malfunction,(3) Improper or inadequate design,(4) Manufacture,(5) Labeling, or(6) User error.”
这个failure和malfuanction有什么区别？

飞羽1234

好问题，为此我专门问了GPT，以下是他的回答：
In the context of 21 FCR 803, "failure" and "malfunction" refer to two different types of problems that can occur with medical devices.
"Failure" refers to a situation where a medical device does not perform as intended or as specified by the manufacturer. This can occur due to a variety of reasons, such as a defect in the device or an error in its use.
"Malfunction," on the other hand, refers to a situation where a medical device deviates from its intended performance, regardless of whether or not it causes harm. This can occur due to a defect in the device, wear and tear, or other factors.
To summarize, "failure" refers specifically to a situation where a medical device fails to perform as intended, while "malfunction" refers more broadly to any deviation from the device's intended performance, whether or not it causes harm.

飞羽1234

按照以上解释，你可以这么理解，血压计无法读数属于failure，血压计读数不准确 误差超出规格要求 就属于malfunction了

秋红叶

飞羽1234 发表于 2023-3-6 11:40
好问题，为此我专门问了GPT，以下是他的回答：
In the context of 21 FCR 803, "failure" and "malfunctio ...

感谢您的回复，但是21 FCR 803关于malfunction的解释是以下这样的，感觉和您提供的failure是一样的。
Malfunction means the failure of a device to meet its performance specifications or otherwise perform as
intended. Performance specifications include all claims made in the labeling for the device. The intended
performance of a device refers to the intended use for which the device is labeled or marketed, as defined
in § 801.4 of this chapter.

飞羽1234

秋红叶 发表于 2023-3-7 11:01
感谢您的回复，但是21 FCR 803关于malfunction的解释是以下这样的，感觉和您提供的failure是一样的。
Ma ...

那这么说Faliure和Malfunction的区别是啥呢

秋红叶

飞羽1234 发表于 2023-3-8 18:20
那这么说Faliure和Malfunction的区别是啥呢

我要是知道，我就不会发帖了