What is the translation of " TECHNICAL FILE " in Chinese?

• 技术文件
• 技术档案
• 技术文档

Examples of using Technical file in English and their translations into Chinese

Technical file.
技术档案.

First technical file.
第一篇技术档案.

Technical Files.
技术档案.

This is a very complex, technical file.
这是一个非常复杂的技术文件。

Safety and technical files should be set up.
应建立安全、技术档案。

The manufacturer must create a technical file.
实验室应建立技术档案。

Technical file should include the following main elements:.
技术档案应当包括以下主要内容：.

The manufacturer must create a technical file.
制造商必须形成技术文档.

They must maintain a technical file to prove conformity.
另外，他们必须保留一份技术文件来证明符合性。

Technical File shall contain the following essential elements:.
技术档案应当包括以下主要内容:.

Similarities and differences between the EU Technical file and US 510(k).
欧盟技术文档与美国510（K）的共性与差异.

A Technical File is required in order to comply with the EMC Directive.
需要技术文件才能符合EMC指令。

Class III products have a different technical file called: Design Dossier.
III类医疗器械有不同的技术文件：设计档案。

The European Union requires a similar set of documentation called a“Technical File.”.
欧盟也要求提供类似的一组文档，它们称为“技术文件”。

Establish user service technical files to prepare for after-sales tracking services;
建立用户服务技术档案,以备售后跟踪服务；.

As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.
作为CE标志过程的一部分，我们也建议您用一位外部专家审查您的技术文件。

To keep a copy of the product's technical file and Declaration of Conformity for ten years;
保存相关技术文件和EU一致性声明10年；.

A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s).
技术文件是用于证明一个医疗器械(MedicalDevice)符合有关指令规定的基本安全和健康要求的文件。

It is also widely used to support declaration of conformity and technical file activity required when CE Marking for the EU.
它还广泛用于支持欧盟CE标志要求的产品合格说明和技术文件活动。

Updating Technical Files to meet the more rigorous requirements by the implementation date.
在实施日期之前更新技术文件以满足更严格的要求。

The Machinery Directive 2006/42/EC does not stipulate that the person authorised to compile the technical file must be employed by the manufacturer.
机械指令2006/42/EC没有规定授权编制技术文件的人员必须是制造商的员工。

Submit a technical file setting out plans for restoration of the premises and for a place for end disposal;
提交一份技术档案，制订修复房舍和最终处置的计划；.

Th inspection bodies shall establish a production license product testing and technical files, and to ensure that documents are complete, true and valid.
第七十八条检验机构应当建立生产许可证产品检验技术档案,并确保档案完整､真实､有效。

To submit a technical file[…] with plans for restoring the present premises and indicating a possible place for final disposal.
提交技术档案[.]提出修复目前房舍并指定可用于最后处置的地方的计划。

A Notified Body must be involved(for products other than class I) and the technical file including the Declaration of Conformity must be prepared.
必须有认证机构参与（I类产品除外），并有包含符合性声明（DelarationofConformity）在内的技术文档.

We will review your Technical File for conformity to the requirements of the directive and provide recommendations on any areas requiring further action or improvements.
我们将审核您的技术文件是否符合指令的要求，并就需要采取进一步行动或改进的任何领域提供建议。

St passenger operators and road transport authorities above the county level should establish passenger vehicle a technical file and file management and safekeeping.
第四十一条客运经营者和县级以上道路运输管理机构应当分别建立客运车辆技术档案和管理档案，并妥善保管。

For all classification types a Technical File must be prepared demonstrating compliance to the directives essential requirements.
对于所有分类类型，必须准备技术文件，证明符合MDR基本要求。