中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

醫(yī)療器械互操作性的英文描述為Medical Device Interoperability，那么醫(yī)療器械互操作性指的是什么呢？

FDA對(duì)其定義如下：

Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product.

醫(yī)療設(shè)備互操作性是指在一個(gè)或多個(gè)設(shè)備、產(chǎn)品、技術(shù)或系統(tǒng)之間安全、可靠和有效地交換和使用信息的能力。這種交換的信息可以體現(xiàn)為各種方式，包括顯示、存儲(chǔ)、解釋、分析和自動(dòng)對(duì)其他產(chǎn)品采取行動(dòng)或控制其他產(chǎn)品。

Medical device interoperability is not limited to unidirectional patient data but includes more complex interactions, such as exerting command and control over a medical device(s). Establishing and implementing appropriate functional, performance, and interface requirements for devices with such interactions is important. One way to achieve this is through use of standardized architectures and communication protocols. Another way is to specify non-standard interface requirements and characteristics in labeling.

醫(yī)療器械互操作性不僅限于單向的患者數(shù)據(jù)，還包括更復(fù)雜的交互，例如對(duì)醫(yī)療器械進(jìn)行命令和控制。為具有這種交互的器械建立和實(shí)現(xiàn)適當(dāng)?shù)墓δ?、性能和接口需求是很重要的。?shí)現(xiàn)這一目標(biāo)的一種方法是使用標(biāo)準(zhǔn)化的體系結(jié)構(gòu)和通信協(xié)議。另一種方法是在標(biāo)簽（這里通常指的是說(shuō)明書(shū)）中指定非標(biāo)準(zhǔn)的接口要求和特性。

醫(yī)療器械的互操作性設(shè)計(jì)要考慮哪些方面？

Manufacturers can choose from many design solutions to create interoperable medical devices. The information model (data attributes), the functional model (role played within the interoperable system), and the architectural model (how the device is connected within the system) should be considered during the design and development of an interoperable medical device. Design inputs should include the desired functional and performance characteristics of the electronic interface.

制造商可以從許多設(shè)計(jì)解決方案中選擇，以創(chuàng)建可互操作的醫(yī)療器械。在設(shè)計(jì)和開(kāi)發(fā)可互操作的醫(yī)療器械時(shí)，應(yīng)該考慮信息模型(數(shù)據(jù)屬性)、功能模型(在互操作系統(tǒng)中扮演的角色)和體系結(jié)構(gòu)模型(器械如何在系統(tǒng)中連接)。設(shè)計(jì)輸入應(yīng)包括所需的功能和性能特征的電子接口。

As a general matter, one action manufacturers can take to reduce risk and facilitate safe and effective interoperability is to clearly set forth in device labeling the functional and performance requirements of their electronic interface. Providing these characteristics along with limitations of the interface or use of the device in an interoperable system can minimize the risks associated with failure to exchange and use data as intended.

一般而言，制造商可采取的一項(xiàng)措施，是在器械標(biāo)簽（這里通常指的是說(shuō)明書(shū)）上明確列出其電子接口的功能和性能要求，以減少風(fēng)險(xiǎn)和促進(jìn)安全有效的互操作性。提供這些特性以及接口或器械在可互操作系統(tǒng)中的使用限制，可以最大限度地降低與無(wú)法按照預(yù)期交換和使用數(shù)據(jù)相關(guān)的風(fēng)險(xiǎn)。

The following considerations should be appropriately tailored to the selected interface technology, and the intended use and use environments for the medical device.

以下考慮應(yīng)根據(jù)所選的接口技術(shù)以及醫(yī)療器械的預(yù)期用途和使用環(huán)境進(jìn)行適當(dāng)調(diào)整。

1. Purpose of the Electronic Interface: Device manufacturers should consider the purpose for each of the electronic interfaces. This should include the types of data exchanges taking place (e.g., sending, receiving, issue command and control).

1. 電子接口的目的:器械制造商應(yīng)該考慮每個(gè)電子接口的目的。這應(yīng)該包括發(fā)生的數(shù)據(jù)交換的類型(例如，發(fā)送、接收、發(fā)出命令和控制)。

2. The Anticipated Users: Manufacturers should determine the anticipated user(s) for each of the electronic interfaces. Examples of users include: clinical user, biomedical engineers, home healthcare user, IT (information technology) professional, system integrator, system designers, patients, researchers, and medical device designers.

2. 預(yù)期用戶: 制造商應(yīng)確定每個(gè)電子接口的預(yù)期用戶。用戶的例子包括:臨床用戶、生物醫(yī)學(xué)工程師、家庭醫(yī)療保健用戶、IT(信息技術(shù))專業(yè)人員、系統(tǒng)集成商、系統(tǒng)設(shè)計(jì)師、患者、研究人員和醫(yī)療器械設(shè)計(jì)師。

3. Risk Management: Manufacturers should consider ways to mitigate risks identified in the risk analysis. This includes risks that arise from others connecting to the electronic interface.

3.風(fēng)險(xiǎn)管理: 制造商應(yīng)考慮降低風(fēng)險(xiǎn)分析中確定的風(fēng)險(xiǎn)的方法。這包括連接到電子接口的其他設(shè)備所產(chǎn)生的風(fēng)險(xiǎn)。

4.Verification and Validation: Manufacturers should establish, maintain, and implement appropriate verification and validation to ensure that their devices with electronic interfaces work correctly prior to delivery, during the integration process, continue to work while in use, and through maintenance and release of software updates.

4.驗(yàn)證和確認(rèn)：制造商應(yīng)建立、維護(hù)和實(shí)施適當(dāng)?shù)尿?yàn)證和確認(rèn)，以確保具有電子接口的器械在交付前、集成過(guò)程中、在使用中，以及維護(hù)和發(fā)布軟件更新后繼續(xù)工作。

5.Labeling Considerations: Manufacturers should include information that users may need to connect predictably and safely to the interface for its intended purpose.

5.標(biāo)簽的考慮: 制造商應(yīng)該包括用戶可能需要預(yù)期和安全連接到其預(yù)期目的的接口的信息。

6.Use of Consensus Standards: Manufacturers should consider the use of consensus standards related to medical device interoperability.

6.使用共識(shí)標(biāo)準(zhǔn): 制造商應(yīng)考慮使用與醫(yī)療器械互操作性相關(guān)的共識(shí)標(biāo)準(zhǔn)。