经常分不清 医疗器械、组件、配件、附件、耗材

苏梳疏

家人们，医疗器械medical device、组件component、配件fitting、附件accessory、耗材consumable这几个到底咋区分？求大佬们指点，已头晕。

找了一些定义：

MDR：
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,(IVD)
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

医疗器械监督管理条例：
医疗器械，是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件；其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；其目的是：
（一）疾病的诊断、预防、监护、治疗或者缓解；
（二）损伤的诊断、监护、治疗、缓解或者功能补偿；
（三）生理结构或者生理过程的检验、替代、调节或者支持；
（四）生命的支持或者维持；
（五）妊娠控制；
（六）通过对来自人体的样本进行检查，为医疗或者诊断目的提供信息。


美国：Medical Device Accessories -Describing Accessories and Classification Pathways
The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component,  part, or accessory, which is –
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
Accessory: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
Component (21 CFR 820.3(c)): “[A]ny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”
Finished Device (21 CFR 820.3(l)): “[A]ny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”
Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
A. Is the article an accessory?-1. Is intended for use with one or more parent devices.-2. Is intended to support, supplement, and/or augment the performance of one or more parent devices.

机智鼠

医疗器械、组件、配件、附件和耗材是医疗器械行业的专业术语，它们之间的区别主要体现在用途、功能和使用场景上。

1.  *医疗器械*:是指通过物理手段或化学手段作用于人体，用于预防、诊断、治疗疾病或者缓解疾病的医学技术产品。例如，血压计、心电图机等。

2.  *组件*:是指医疗器械中具有独立功能的组成部分，可以单独使用或与其他部分组合使用。例如，心脏起搏器的电池就是其组件之一。

3.  *配件*:是指医疗器械中与主体部分配套使用的辅助设备或材料。例如，手术刀的刀片和刀柄就构成了手术刀的配件。

4.  *附件*:通常指医疗器械中与主体部分配套使用的外部设备或材料。例如，呼吸机的面罩和管路就构成了呼吸机的附件。

5.  *耗材*:是指医疗器械在使用过程中需要更换的易耗品，如注射器、输液器等。

在实际应用中，这些术语的使用需要根据具体的产品和使用场景来判断。同时，由于医疗器械涉及到人体健康，因此在使用和选择时必须严格遵守相关的法规和指南，确保产品的安全性和有效性。

【鼠鼠还在学习中，内容仅供参考（药搭GMP软件提供技术支持）】

zk5032

感谢分享，学习了！

yhgz

多谢分享！

Gordonuih

机智鼠 发表于 2024-10-22 08:36
医疗器械、组件、配件、附件和耗材是医疗器械行业的专业术语，它们之间的区别主要体现在用途、功能和使用场 ...

“配件”和“附件”的定义区别还是有一些疑问。附件的这个“外部”应该如何理解？卸下大佬

桃子大魔王ww

Gordonuih 发表于 2024-11-6 17:35
“配件”和“附件”的定义区别还是有一些疑问。附件的这个“外部”应该如何理解？卸下大佬

配件是为了满足产品原有目的而必须使用的零件，附件是在产品原有功能上为增加其他功能使用的零件