引言：隨著國(guó)際貿(mào)易和交流的日趨頻繁，醫(yī)療器械從業(yè)者們常常面對(duì)不同國(guó)家和區(qū)域有關(guān)醫(yī)療器械管控的要求。由于各國(guó)對(duì)醫(yī)療器械監(jiān)管的差異，術(shù)語和要求也存在不同。今天，為大家介紹設(shè)計(jì)歷史文件( DHF )與設(shè)備主記錄( DMR )與設(shè)備歷史記錄( DHR ) 之間的差異和其包含的文件清單。

DHF – Design History File The DHF is the design history file. 

DHF 是設(shè)計(jì)歷史文檔。 

As you go through the design anddevelopment process for your medical device, the documentation that you createis going to be contained here. 

它包含在完成醫(yī)療器械的設(shè)計(jì)和開發(fā)過程時(shí)所創(chuàng)建的文檔。 

According to the FDA,  the designhistory file shall contain or reference the records necessary to demonstratethat the design was developed in accordance with the approved design plan andthe requirements of this part  ( 21CFR Part 820.30 ) . Each manufacturer shall establish and maintain a DHFfor each type of device.

根據(jù) FDA 的規(guī)定，設(shè)計(jì)歷史文件應(yīng)包含或引用必要的記錄，以證明設(shè)計(jì)是根據(jù)批準(zhǔn)的設(shè)計(jì)方案和 21 CFR Part 820.30 的要求制定的。每個(gè)制造商應(yīng)為每種類型的器械建立和保存 DHF 文檔。 

The actual idea of the DHF is fairlystraightforward. In practice, that can be a bit of a challenge if you don’t compileit as you go. 

DHF 的實(shí)際意圖相當(dāng)簡(jiǎn)單。如果你在實(shí)踐中不去編寫它，這可能是一個(gè)挑戰(zhàn)。 

You need to include or provide a referenceto all of the records related to the activities you did during the design anddevelopment process. 

你需要包括或提供你在設(shè)計(jì)和開發(fā)過程中所做的活動(dòng)有關(guān)的所有記錄。 

That means you need all of the user needsand design inputs you came up with at the start of the project. 

這意味著你需要在項(xiàng)目開始時(shí)提出的所有用戶需求和設(shè)計(jì)輸入。 

All of the design outputs that yougenerated to build the device. 

為制成器械而生成的所有設(shè)計(jì)輸出。

 All of the  designverification and validation protocols and reports . 

所有的設(shè)計(jì)驗(yàn)證和確認(rèn)的方案和報(bào)告。 

Plus, all of design reviews that went alongwith all of that…and don’t forget everything for transferring the device tomanufacturing too. 

此外，與此相關(guān)的所有的設(shè)計(jì)評(píng)審 ... 不要忘記把器械轉(zhuǎn)移到生產(chǎn)的過程。 

Once you’ve gotten all of those documentscompiled into your DHF, the next acronym that needs to be tackled is the DMR. 

一旦將所有這些文檔編寫到 DHF 中，需要解決的下一個(gè)首字母縮略詞就是 DMR 。

DMR – Device Master Record The DMR is the device master record. 

DMR 是器械主記錄。 

Everything you need to know to build andtest the device is contained here. 

它包含了制造和測(cè)試器械所需的一切。 

According to the FDA,  the DMR foreach type of device shall include, or refer to the location of, the followinginformation:

根據(jù) FDA 的規(guī)定，每種醫(yī)療器械的 DMR 應(yīng)包括或提及以下信息的位置：

(a)    Device specificationsincluding appropriate drawings, composition, formulation, componentspecifications, and software specifications; 

器械規(guī)格，包括適當(dāng)?shù)膱D紙，成分，配方，組件規(guī)格和軟件規(guī)格; 

(b)    Production processspecifications including the appropriate equipment specifications, productionmethods, production procedures, and production environment specifications; 

生產(chǎn)工藝規(guī)范，包括適當(dāng)?shù)脑O(shè)備規(guī)格，生產(chǎn)方法，生產(chǎn)程序和生產(chǎn)環(huán)境標(biāo)準(zhǔn); 

(c)    Quality assuranceprocedures and specifications including acceptance criteria and the qualityassurance equipment to be used; 

質(zhì)量保證程序和規(guī)范，包括驗(yàn)收標(biāo)準(zhǔn)和使用的質(zhì)量保證設(shè)備; 

(d)    Packaging and labelingspecifications, including methods and processes used; 

包裝和標(biāo)簽規(guī)格，包括采用的方法和工藝; 

(e)    Installation,maintenance, and servicing procedures and methods.

 安裝，維護(hù)和維修程序和方法。 

Each manufacturer shall ensure that eachDMR is prepared and approved in accordance with 21CFR Part 820.40.

每個(gè)制造商應(yīng)確保每個(gè) DMR 按照 21 CFR Part 820.40 進(jìn)行準(zhǔn)備和批準(zhǔn)。 

Some parts of this should sound a lot likewhat you just got done compiling in the DHF. 

這里的部分內(nèi)容很像剛剛提到的 DHF 的編寫。 

The device specifications,  packaging  and  labeling  specificationswere part of the design outputs you created earlier. 

器械規(guī)格，包裝和標(biāo)簽規(guī)格是你之前創(chuàng)建的設(shè)計(jì)輸出的一部分。 

The production process specifications werepart of the  design transfer  youdid earlier as well. 

生產(chǎn)工藝規(guī)范是之前做過的設(shè)計(jì)轉(zhuǎn)換的一部分。 

Even the quality assurance procedures andspecifications were created earlier, because those include defining theacceptance criteria which is part of design output. 

質(zhì)量保證程序和規(guī)范也是早些時(shí)候創(chuàng)建的，因?yàn)槠渲邪ㄗ鳛樵O(shè)計(jì)輸出一部分定義的接受標(biāo)準(zhǔn)。 

The good news is that the FDA only requiresyou to reference the required items, not duplicate them. 

好消息是， FDA 只要求你參考所需的項(xiàng)目，而不是重復(fù)它們。 

If you were really organized in thecreation of your DHF, it’s going to be really easy to reference that locationin your DMR. 

如果你準(zhǔn)備了要?jiǎng)?chuàng)建的 DHF ，那么在你的 DMR 中引用它將非常容易。 

The difference between the DHF and the DMRis in that first letter – design vs. device. DHF 與 DMR 之間的區(qū)別在于第一個(gè)字母 -  設(shè)計(jì)與器械。 

The DHF is focused on the history of thedesign and ensuring it was done according to the FDA regulations. 

DHF 側(cè)重于設(shè)計(jì)的歷史，并確保按照 FDA 的規(guī)定進(jìn)行。

 The DMR is focused on the device andensuring you have all of the necessary items to build, test, package, andservice it. 

DMR 側(cè)重于器械，確保擁有制造，測(cè)試，包裝和維護(hù)所有必需的項(xiàng)目。

 Now that you’ve designed the device (DHF)and have the recipe to build and test it (DMR), it’s time to actually make thedevice. 

現(xiàn)在你已經(jīng)設(shè)計(jì)了該器械（ DHF ）并且擁有了“處方”來構(gòu)建和測(cè)試它（ DMR ），現(xiàn)在是時(shí)候制造器械了。 

That’s when the DHR comes into play. 

也就輪到 DHR 發(fā)揮作用了。

DHR – Device History Record The DHR is the device history record. 

DHR 是器械歷史記錄 

Everything you did to make the device iscontained here. 

它包括制造器械所做的一切事情。 

According to the FDA,  the DHR shallinclude, or refer to the location of, the following information:

根據(jù) FDA 的規(guī)定， DHR 應(yīng)包括或參閱以下信息：

(a) The dates of manufacture;

生產(chǎn)日期

(b) The quantity manufactured;

生產(chǎn)數(shù)量

(c) The quantity released fordistribution;

交付數(shù)量

(d) The acceptance records whichdemonstrate the device is manufactured in accordance with the DMR; 

證明器械的制造符合 DMR 的檢驗(yàn)記錄

(e) The primary identification label andlabeling used for each production unit; 

主要的標(biāo)簽和對(duì)應(yīng)每個(gè)產(chǎn)品的標(biāo)簽 ; 

(f) Any unique deviceidentifier (UDI) or universal product code (UPC), and any other deviceidentification(s) and control number(s) used. 

任何唯一的器械標(biāo)識(shí)符（UDI）或通用產(chǎn)品代碼（UPC），以及使用的任何其他器械標(biāo)識(shí)和控制編號(hào)。 

Each manufacturer shall establish andmaintain procedures to ensure that DHR's for each batch, lot, or unit aremaintained to demonstrate that the device is manufactured in accordance withthe DMR and the requirements of this part.

每個(gè)制造商都應(yīng)建立和保存程序，以確保每個(gè)批次或單位的 DHR 都能確保證明該設(shè)備是按照 DMR 和本部分的要求制造的。 

The device history record is literally thehistory of the device. 

器械歷史記錄字面意思就是是器械的歷史。 

Everything that you complied in the DMR wasused to make the device. 

制作設(shè)備的所有內(nèi)容都編寫在 DMR 中。 

The history and information on how you madethe device in accordance with the DMR is stored in the DHR. Much like the DHFis the history of the design, the DHR is the history of the device. 

根據(jù) DMR 制作設(shè)備的歷史和信息都記錄在 DHR 中。就像 DHF 是設(shè)計(jì)的歷史一樣， DHR 是設(shè)備的歷史。

DHF vs. DMR vs. DHR While these three acronyms can seeconfusing and easily interchangeable when you first hear them, if you look atthe actual terms, they’re surprisingly descriptive. 

雖然這三個(gè)縮寫詞在你第一次聽到時(shí)可能會(huì)感到困惑并且很容易混淆，但如果看一下實(shí)際的術(shù)語，它們會(huì)有驚人的描述性。 

DHF - Design History File DHF- 設(shè)計(jì)歷史文檔 

DMR - Device Master Record DMR – 器械主文檔 

DHR - Device History Record DHR – 器械歷史記錄 

You start with the history of the design,which leads to the record of how to build and test the device, which leads tothe history of the device you actually made. 

從設(shè)計(jì)的歷史開始，引向構(gòu)建和測(cè)試器械的記錄，再引向制造設(shè)備的實(shí)際歷史。 

If you’re like me, the part you mix up themost is when the D stands for design vs. device. 

你可以像我一樣，最容易混淆的部分是 D ，代表設(shè)計(jì)和器械。 

I keep them straight by remembering that Ineed a file for the design and a record of the device. 

我是這樣記的：我需要一個(gè)設(shè)計(jì)的文檔和器械的記錄。 

When I see the R at the end, I know it’sdevice related. 

當(dāng)我看到最后的 R 時(shí)，我知道它是與器械相關(guān)的。 

Hopefully that simple trick will help clearup any lingering confusion. 

希望這個(gè)簡(jiǎn)單的技巧會(huì)有助于消除長(zhǎng)久的困惑。