7.5 Production and service provision 生產(chǎn)和服務(wù)提供
7.5.1 Control of production and service provision 生產(chǎn)和服務(wù)提供的控制
Production andservice provision shall be planned, carried out, monitored and controlled toensure that product conforms to specification. As appropriate, productioncontrols shall include but are not limited to:
應(yīng)當(dāng)對(duì)生產(chǎn)和服務(wù)提供進(jìn)行策劃、實(shí)施、監(jiān)測(cè)和控制來(lái)保證產(chǎn)品符合質(zhì)量標(biāo)準(zhǔn)。適用時(shí)，產(chǎn)品控制包括但不限于以下內(nèi)容：
a) documentation of procedures andmethods for the control of production (see 4.2.4);
用于產(chǎn)品控制的文件化程序和方法（見(jiàn)4.2.4）
b) qualification of infrastructure;
基礎(chǔ)設(shè)施確認(rèn)；（刪減，替代）
c)implementation of monitoring and measurement of process parameters and productcharacteristics;
過(guò)程參數(shù)和產(chǎn)品特性監(jiān)控和測(cè)量的實(shí)施；
d) availabilityand use of monitoring and measuring equipment;
控制和測(cè)量設(shè)備的獲得和使用；
e)implementation of defined operations for labelling and packaging;
已確定的貼標(biāo)和包裝操作程序的實(shí)施；
f)implementation of product release, delivery and post-delivery activities.
產(chǎn)品放行、交付和交付后活動(dòng)的實(shí)施。
刪減了YY/T0287中7.5.1.1內(nèi)的a)和b)、c)，用新的a)和b)來(lái)替代。
The organizationshall establish and maintain a record (see 4.2.5) for eachmedical device or batch of medical devices that provides traceability to theextent specified in 7.5.9 and identifies the amount manufactured andamount approved for distribution. The record shall be verified and approved.
組織應(yīng)當(dāng)確定和保留每臺(tái)醫(yī)療器械或醫(yī)療器械批的記錄，以便提供規(guī)定在7.5.9項(xiàng)下追溯范圍，以及確認(rèn)生產(chǎn)的數(shù)量和批準(zhǔn)的用于銷售的數(shù)量。
7.5.2 Cleanliness of product 產(chǎn)品的清潔
The organizationshall document requirements for cleanliness of product or contamination controlof product if:
考慮如下情況，組織應(yīng)當(dāng)形成文件用于產(chǎn)品的清潔和產(chǎn)品污染控制：
a) product iscleaned by the organization prior to sterilization or its use;
在滅菌或其使用前組織對(duì)其進(jìn)行清潔的產(chǎn)品；
b) product issupplied non-sterile and is to be subjected to a cleaning process prior tosterilization or its use;
以非無(wú)菌形式提供的，在滅菌或使用之前必須進(jìn)行清潔的產(chǎn)品。
c) product cannot be cleaned priorto sterilization or its use, and its cleanliness is of significance in use;
在滅菌或其使用之前無(wú)法對(duì)其進(jìn)行清潔，其本身清潔度對(duì)使用結(jié)果具有重大影響的產(chǎn)品。（新增）
d) product issupplied to be used non-sterile, and its cleanliness is of significance in use;
無(wú)需滅菌，但其本身之清潔度對(duì)使用結(jié)果具重大影響的產(chǎn)品。（新增）
e) processagents are to be removed from product during manufacture.
在生產(chǎn)期間應(yīng)當(dāng)去除產(chǎn)品的工藝試劑（清潔劑）。
If product iscleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply priorto the cleaning process.
如果產(chǎn)品按照a) 或 b)進(jìn)行了清潔，在清潔過(guò)程之前不必滿足6.4.1項(xiàng)下的需求。
7.5.3 Installation activities 安裝活動(dòng)
The organizationshall document requirements for medical device installation and acceptancecriteria for verification of installation, as appropriate.
適當(dāng)時(shí)，組織應(yīng)建用于醫(yī)療器械安裝和安裝確認(rèn)的質(zhì)量標(biāo)準(zhǔn)的文件化要求。
If the agreedcustomer requirements allow installation of the medical device to be performedby an external party other than the organization or its supplier, theorganization shall provide documented requirements for medical deviceinstallation and verification of installation.
如果經(jīng)同意的顧客要求允許除組織或其供應(yīng)商（代理商）以外的人員安裝醫(yī)療器械時(shí)，則組織應(yīng)提供文件化的安裝和安裝確認(rèn)要求。
Records ofmedical device installation and verification of installation performed by theorganization or its supplier shall be maintained (see 4.2.5).
由組織或其供應(yīng)商（代理商）實(shí)施的醫(yī)療器械安裝和安裝確認(rèn)的相關(guān)記錄應(yīng)當(dāng)予以保留。（見(jiàn)4.2.5）