隨著國際貿(mào)易和交流的日趨頻繁，醫(yī)療器械從業(yè)者們常常面對不同國家和區(qū)域有關醫(yī)療器械管控的要求。由于各國對醫(yī)療器械監(jiān)管的差異，術(shù)語和要求也存在不同。今天，為大家介紹設計歷史文件( DHF )與設備主記錄( DMR )與設備歷史記錄( DHR ) 之間的差異和其包含的文件清單。
引言：隨著國際貿(mào)易和交流的日趨頻繁，醫(yī)療器械從業(yè)者們常常面對不同國家和區(qū)域有關醫(yī)療器械管控的要求。由于各國對醫(yī)療器械監(jiān)管的差異，術(shù)語和要求也存在不同。今天，為大家介紹設計歷史文件( DHF )與設備主記錄( DMR )與設備歷史記錄( 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 是設計歷史文檔。
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)療器械的設計和開發(fā)過程時所創(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，設計歷史文件應包含或引用必要的記錄，以證明設計是根據(jù)批準的設計方案和 21 CFR Part 820.30 的要求制定的。每個制造商應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 的實際意圖相當簡單。如果你在實踐中不去編寫它，這可能是一個挑戰(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計和開發(fā)過程中所做的活動有關的所有記錄。
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目開始時提出的所有用戶需求和設計輸入。
All of the design outputs that yougenerated to build the device.
為制成器械而生成的所有設計輸出。
All of the designverification and validation protocols and reports .
所有的設計驗證和確認的方案和報告。
Plus, all of design reviews that went alongwith all of that…and don’t forget everything for transferring the device tomanufacturing too.
此外，與此相關的所有的設計評審 ... 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?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?shù)脑O備規(guī)格，生產(chǎn)方法，生產(chǎn)程序和生產(chǎn)環(huán)境標準;
(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，包括驗收標準和使用的質(zhì)量保證設備;
(d) Packaging and labelingspecifications, including methods and processes used;
包裝和標簽規(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.
每個制造商應確保每個 DMR 按照 21 CFR Part 820.40 進行準備和批準。
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，包裝和標簽規(guī)格是你之前創(chuàng)建的設計輸出的一部分。
The production process specifications werepart of the design transfer youdid earlier as well.
生產(chǎn)工藝規(guī)范是之前做過的設計轉(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)范也是早些時候創(chuàng)建的，因為其中包括作為設計輸出一部分定義的接受標準。
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目，而不是重復它們。
If you were really organized in thecreation of your DHF, it’s going to be really easy to reference that locationin your DMR.
如果你準備了要創(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)別在于第一個字母 - 設計與器械。
The DHF is focused on the history of thedesign and ensuring it was done according to the FDA regulations.
DHF 側(cè)重于設計的歷史，并確保按照 FDA 的規(guī)定進行。
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，測試，包裝和維護所有必需的項目。
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)設計了該器械（ DHF ）并且擁有了“處方”來構(gòu)建和測試它（ DMR ），現(xiàn)在是時候制造器械了。
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 的檢驗記錄
(e) The primary identification label andlabeling used for each production unit;
主要的標簽和對應每個產(chǎn)品的標簽 ;
(f) Any unique deviceidentifier (UDI) or universal product code (UPC), and any other deviceidentification(s) and control number(s) used.
任何唯一的器械標識符（UDI）或通用產(chǎn)品代碼（UPC），以及使用的任何其他器械標識和控制編號。
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.
每個制造商都應建立和保存程序，以確保每個批次或單位的 DHR 都能確保證明該設備是按照 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 制作設備的歷史和信息都記錄在 DHR 中。就像 DHF 是設計的歷史一樣， DHR 是設備的歷史。
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.
雖然這三個縮寫詞在你第一次聽到時可能會感到困惑并且很容易混淆，但如果看一下實際的術(shù)語，它們會有驚人的描述性。
DHF - Design History File DHF- 設計歷史文檔
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.
從設計的歷史開始，引向構(gòu)建和測試器械的記錄，再引向制造設備的實際歷史。
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 ，代表設計和器械。
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：我需要一個設計的文檔和器械的記錄。
When I see the R at the end, I know it’sdevice related.
當我看到最后的 R 時，我知道它是與器械相關的。
Hopefully that simple trick will help clearup any lingering confusion.
希望這個簡單的技巧會有助于消除長久的困惑。