7.5 Production and service provision 生產和服務提供
7.5.1 Control of production and service provision 生產和服務提供的控制
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:
應當對生產和服務提供進行策劃、實施、監測和控制來保證產品符合質量標準。適用時，產品控制包括但不限于以下內容：
a) documentation of procedures andmethods for the control of production (see 4.2.4);
用于產品控制的文件化程序和方法（見4.2.4）
b) qualification of infrastructure;
基礎設施確認；（刪減，替代）
c)implementation of monitoring and measurement of process parameters and productcharacteristics;
過程參數和產品特性監控和測量的實施；
d) availabilityand use of monitoring and measuring equipment;
控制和測量設備的獲得和使用；
e)implementation of defined operations for labelling and packaging;
已確定的貼標和包裝操作程序的實施；
f)implementation of product release, delivery and post-delivery activities.
產品放行、交付和交付后活動的實施。
刪減了YY/T0287中7.5.1.1內的a)和b)、c)，用新的a)和b)來替代。
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.
組織應當確定和保留每臺醫療器械或醫療器械批的記錄，以便提供規定在7.5.9項下追溯范圍，以及確認生產的數量和批準的用于銷售的數量。
7.5.2 Cleanliness of product 產品的清潔
The organizationshall document requirements for cleanliness of product or contamination controlof product if:
考慮如下情況，組織應當形成文件用于產品的清潔和產品污染控制：
a) product iscleaned by the organization prior to sterilization or its use;
在滅菌或其使用前組織對其進行清潔的產品；
b) product issupplied non-sterile and is to be subjected to a cleaning process prior tosterilization or its use;
以非無菌形式提供的，在滅菌或使用之前必須進行清潔的產品。
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法對其進行清潔，其本身清潔度對使用結果具有重大影響的產品。（新增）
d) product issupplied to be used non-sterile, and its cleanliness is of significance in use;
無需滅菌，但其本身之清潔度對使用結果具重大影響的產品。（新增）
e) processagents are to be removed from product during manufacture.
在生產期間應當去除產品的工藝試劑（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.
如果產品按照a) 或 b)進行了清潔，在清潔過程之前不必滿足6.4.1項下的需求。
7.5.3 Installation activities 安裝活動
The organizationshall document requirements for medical device installation and acceptancecriteria for verification of installation, as appropriate.
適當時，組織應建用于醫療器械安裝和安裝確認的質量標準的文件化要求。
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.
如果經同意的顧客要求允許除組織或其供應商（代理商）以外的人員安裝醫療器械時，則組織應提供文件化的安裝和安裝確認要求。
Records ofmedical device installation and verification of installation performed by theorganization or its supplier shall be maintained (see 4.2.5).
由組織或其供應商（代理商）實施的醫療器械安裝和安裝確認的相關記錄應當予以保留。（見4.2.5）