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ISO13485beplay|网页版辅导---ISO13485-2016中英文对照 产品实现(7.5.1~7.5.3)
7.5 Production and service provision 生产和服务提供
7.5.1 Control of production and service provision 生产和服务提供的控制
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:应当对生产和服务提供进行策划、实施、监测和控制来保证产品符合质量标准。适用时,产品控制包括但不限于以下内容:
a) documentation of procedures andmethods for the control of production (see 4.2.4);用于产品控制的文件化程序和方法(见4.2.4)
b) qualification of infrastructure;基础设施确认;(删减,替代)
c)implementation of monitoring and measurement of process parameters and productcharacteristics;过程参数和产品特性监控和测量的实施;
d) availabilityand use of monitoring and measuring equipment;控制和测量设备的获得和使用;
e)implementation of defined operations for labelling and packaging;已确定的贴标和包装操作程序的实施;
f)implementation of product release, delivery and post-delivery activities.产品放行、交付和交付后活动的实施。删减了YY/T0287中7.5.1.1内的a)和b)、c),用新的a)和b)来替代。
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.组织应当确定和保留每台医疗器械或医疗器械批的记录,以便提供规定在7.5.9项下追溯范围,以及确认生产的数量和批准的用于销售的数量。
7.5.2 Cleanliness of product 产品的清洁
The organizationshall document requirements for cleanliness of product or contamination controlof product if:考虑如下情况,组织应当形成文件用于产品的清洁和产品污染控制:
a) product iscleaned by the organization prior to sterilization or its use;在灭菌或其使用前组织对其进行清洁的产品;
b) product issupplied non-sterile and is to be subjected to a cleaning process prior tosterilization or its use;以非无菌形式提供的,在灭菌或使用之前必须进行清洁的产品。
c) product cannot be cleaned priorto sterilization or its use, and its cleanliness is of significance in use;在灭菌或其使用之前无法对其进行清洁,其本身清洁度对使用结果具有重大影响的产品。(新增)
d) product issupplied to be used non-sterile, and its cleanliness is of significance in use;无需灭菌,但其本身之清洁度对使用结果具重大影响的产品。(新增)
e) processagents are to be removed from product during manufacture.在生产期间应当去除产品的工艺试剂(清洁剂)。
If product iscleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply priorto the cleaning process.如果产品按照a) 或 b)进行了清洁,在清洁过程之前不必满足6.4.1项下的需求。
7.5.3 Installation activities 安装活动
The organizationshall document requirements for medical device installation and acceptancecriteria for verification of installation, as appropriate.适当时,组织应建用于医疗器械安装和安装确认的质量标准的文件化要求。
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.如果经同意的顾客要求允许除组织或其供应商(代理商)以外的人员安装医疗器械时,则组织应提供文件化的安装和安装确认要求。
Records ofmedical device installation and verification of installation performed by theorganization or its supplier shall be maintained (see 4.2.5).由组织或其供应商(代理商)实施的医疗器械安装和安装确认的相关记录应当予以保留。(见4.2.5)

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