ISO13485-2016中英文对照(八)-产品实现7.5

7 Product realization7 产品实现7.5Production and service provision 生产和服务提供7.5.1Control of production and service

7 Product realization

7 产品实现

 

7.5Production and service provision 生产和服务提供

7.5.1Control 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/T02877.5.1.1内的a)b)c),用新的a)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。

7.5.2Cleanliness 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) 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。

7.5.3Installation 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

7.5.4Servicing activities 服务活动

If servicing of the medical deviceis a specified requirement, the organization shall document servicing procedures,reference materials, and reference measurements, as necessary, for performingservicing activities and verifying that product requirements are met.

如果医疗器械的服务有特殊要去,组织应当建立相应服务程序,标准品和标准测量程序,如适用,来实施相应的服务活动和与产品要求相符合的验证。

The organization shall analyses recordsof servicing activities carried out by the organization or its supplier:

组织应当分析由组织或其供应商(代理商)实施的服务活动的相关记录:

a) to determine if the informationis to be handled as a complaint;

来确定是否信息作为抱怨来处理。

b) as appropriate, for input to theimprovement process.

如适用,可以作为改进过程的输入。

Records of servicing activitiescarried out by the organization or its supplier shall be maintained (see 4.2.5). (新增)

由组织或其供应商(代理商)实施的服务活动的记录应当予以保留.(见4.2.5

删减了,原来YY/T0287中的“在规定有服务要求的情况下,必要时,组织应建立用于服务提供活动并验证该服务是否满足规定要求的形成文件的程序、作业指导书、参考材料和测量程序。”以及一个备注内容。

7.5.5Particular requirements for sterile medical devices 无菌医疗器械的专用要求

The organizationshall maintain records of the sterilization process parameters used for each sterilizationbatch (see 4.2.5). Sterilization records shall be traceableto each production batch of medical devices.

组织应当记录每一个灭菌批次所使用的灭菌工艺参数(见4.2.5)。灭菌记录应当能够追溯每个医疗器械生产批次。

7.5.6Validation of processes for production and service provision 生产和服务提供的工艺验证

The organizationshall validate any processes for production and service provision where theresulting output cannot be or is not verified by subsequent monitoring ormeasurement and, as a consequence, deficiencies become apparent only after theproduct is in use or the service has been delivered.

组织应当验证任何用于生产和服务提供的工艺,因为输出的结果通过监测或测量不可能或无法被证实,最终导致的结果是只有当产品被使用和交付时缺陷才被发现。

Validation shalldemonstrate the ability of these processes to achieve planned results consistently.

验证应当证明这些工艺的能力,从而达到预期的一致性的结果。

The organizationshall document procedures for validation of processes, including:

组织应当建立工艺验证的程序,包括:

a) definedcriteria for review and approval of the processes;

确定的审核和批准这些工艺的标准

b) equipmentqualification and qualification of personnel;

设备确认(性能确认)和人员的确认(指培训);

c) use ofspecific methods, procedures and acceptance criteria;

专属方法的使用,程序和可接受标准;(新增)

d) asappropriate, statistical techniques with rationale for sample sizes;

如适用,针对样本量的带有依据性的统计学技术。

e) requirementsfor records (see 4.2.5);

记录的要求(见4.2.5);

f) revalidation, including criteria for revalidation;

再验证,包括再验证的标准。(新增)

g) approval of changes to theprocesses.

工艺变更的批准。(新增)

The organizationshall document procedures for the validation of the application of computersoftware used in production and service provision. Such software applicationsshall be validated prior to initial use and, as appropriate, after changes tosuch software or its application. The specific approach and activities associatedwith software validation and revalidation shall be proportionate to the risk associatedwith the use of the software, including the effect on the ability of theproduct to conform to specifications.

组织应当建立用于生产和服务提供的计算机软件应用验证的程序。在初始使用之前,这些计算机应用软件应当经过验证,相应的,在其软件变更或应用后也应进行验证。与计算应用软件有关的验证和再验证的专属方法和活动应当与使用软件相对应的风险等级相适应,包括产品符合标准能力的影响。

Records of the results and conclusion of validation and necessary actions from thevalidation shall be maintained (see 4.2.4 and 4.2.5).

验证结论和结果以及从验证中引申出来的必要措施的(新增)相应记录都应当予以保留。(见4.2.44.2.5

7.5.7 Particular requirements for validation ofprocesses for sterilization and sterile

barrier systems

用于无菌以及无菌隔离器系统工艺验证的专属要求(新增)

The organization shall documentprocedures (see 4.2.4) for the validation of processesfor sterilization and sterile barrier systems.

组织应当建立文件化的程序(见4.2.4)用于无菌以及无菌隔离器系统工艺验证(新增)

Processes for sterilization andsterile barrier systems shall be validated prior to implementation and followingproduct or process changes, as appropriate.

在产品实施前以及依据生产或工艺变更用于无菌以及无菌隔离器系统的工艺应当经过适当的验证。(增加无菌隔离器内容)

Records of theresults and, conclusion of validation and necessary actions from the validationshall be maintained (see 4.2.4 and 4.2.5).

验证结论和结果以及从验证中引申出来的必要措施的(新增)相应记录都应当予以保留。(见4.2.44.2.5

NOTE Further information can befound in ISO 11607-1 and ISO 11607-2.

注:详细的信息请参见ISO11607-1ISO11607-2。(新增)

7.5.8Identification 标识

The organizationshall document procedures for product identification and identify product bysuitable means throughout product realization.

组织应当在产品实现的全过程中,建立产品标识的文件化程序,并通过合适的意义来标识产品。

The organizationshall identify product status with respect to monitoring and measurement requirementsthroughout product realization. Identification of product status shall bemaintained throughout production, storage, installation and servicing ofproduct to ensure that only product that has passed the required inspectionsand tests or released under an authorized concession is dispatched, used orinstalled.

组织在产品的实现过程中应当依据监测和测量要对产品的状态进行标识。产品状态标识在产品生产、存储、安装和服务时都应当予以保留,从而保证只有通过必要的检查和测试或在授权让步下放行,设备才可以得以邮寄、使用或安装。(原文在YY/T0287 7.5.3.3状态标识项下)

If required by applicable regulatoryrequirements, the organization shall document a system to assign unique deviceidentification to the medical device.

如果相应的法律法规有要求,组织应当建立一个系统以便为医疗器械分配一个唯一的器械标识。(新增)

The organizationshall document procedures to ensure that medical devices returned to the organizationare identified and distinguished from conforming product.

组织应当建立程序来保证医疗器械返回组织时被标识清楚并与合格产品进行区分。

7.5.9 Traceability可追溯性

7.5.9.1General总则

The organizationshall document procedures for traceability. These procedures shall define theextent of traceability in accordance with applicable regulatory requirementsand the records to be maintained (see 4.2.5).

组织应当建立可追溯性程序。依据相应的法律法规,这些程序应当界定清楚可追溯性范围,相应的记录应当予以保留(见4.2.5)。

删减:YY/T0287中“有可追溯性要求的场合,组织应控制和记录产品的唯一性标识( 4.2.4)。”另外还有一个备注项。

7.5.9.2Particular requirements for implantable medical devices

植入性医疗器械的专属要求

The recordsrequired for traceability shall include records of components, materials, andconditions for the work environment used, if these could cause the medicaldevice not to satisfy its specified safety and performance requirements.

如果这些条件可能导致医疗器械不能满足其安全和性能要求,用于追溯性的相关记录应当包括组件、材料、使用的工作环境的条件等相关内容。

The organizationshall require that suppliers of distribution services or distributors maintainrecords of the distribution of medical devices to allow traceability and thatthese records are available for inspection.

组织应当要求销售服务的供应商(代理商)或销售员保留医疗器械的销售记录,以便于追溯,同时记录可以用于检查所需。

Records of thename and address of the shipping package consignee shall be maintained (see 4.2.5).

货运包装收件人的地址和名字的记录应当予以保留。(见4.2.5

7.5.10Customer property 顾客财产

The organizationshall identify, verify, protect, and safeguard customer property provided foruse or incorporation into the product while it is under the organization’scontrol or being used by the organization. If any customer property is lost,damaged or otherwise found to be unsuitable for use, the organization shallreport this to the customer and maintain records (see 4.2.5).

当产品在组织的控制下或准备在组织中使用时,组织应当确定、核实、保护和保卫供其使用或构成产品一部分的顾客财产。如果任何顾客财产损失、毁坏或发现不适用情况时,组织应当向客户进行告知并保留相关记录(见4.2.5)。

删减YY/T0287备注项。

7.5.11Preservation of product 产品防护

The organization shalldocument procedures for preserving the conformity of product to requirements duringprocessing, storage, handling, and distribution. Preservation shall apply tothe constituent parts of a medical device.

组织应当建立防护程序用以在制造、存储、处理和销售过程中防护产品从而符合产品防护方面的要求,防护也应适用于产品的组成部分。

The organization shall protectproduct from alteration, contamination or damage when exposed to expectedconditions and hazards during processing, storage, handling, and distributionby:

当产品处于在预期的条件下以及处于生产过程、存储、处理和销售的危害下时,组织应当通过以此措施保护产品远离变化、污染、损害:

a) designing and constructingsuitable packaging and shipping containers;

设计和制造合适包装和运输容器;

b) documenting requirements forspecial conditions needed if packaging alone cannot provide preservation.

如果仅靠包装不能提供保护时,针对专有的必须的条件形成文件化的要求。

If special conditions are required,they shall be controlled and recorded (see 4.2.5).

如果确实需要特殊情况,这些情况应当予以控制和记录(见4.2.5

本部分内容描述与YY/T0287有很多不同。

   

总结:本部分内容与YY/T0287最大的不同是文件格式排序不一样。其次三个部分文件内容增加最多,变化最大。7.5.47.5.77.5.11

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