【文章內容簡介】 given.本附錄包含ISO 11737本部分規(guī)定要求的執(zhí)行，所給指南沒有規(guī)定是詳盡的，但關心的最重要的方面應給出。Methods other than those given in this annex may be used, but these alternative methods should be demonstrated as being effective in achieving pliance with the requirements of this part of ISO ，對于其他可供選擇的方法應被論證This annex is not intended as a checklist for assessing pliance with the requirements of this part of ISO 11737要求的清單 。 Normative references參考標準The requirements of documents included as normative references are requirements of this part of ISO 11737 only to the extent that they are cited in a normative part of this part of ISO 11737。 the citation may be to an entire standard or limited to specific clauses.參考文件包含參考標準作為本部分ISO 11737要求，只是本部分ISO 11737標準引用的程度；該引用可能是標準的全部也可能限于規(guī)定的條款 Definitions定義No guidance Quality management system elements質量管理體系要素NOTE It is not a requirement of this part of ISO 11737 to have a full quality management system, but the elements ofa quality management system that are the minimum necessary to control the determination of bioburden as used in the validation and monitoring of medical devices to be sterilized are normatively referenced at appropriate places in the text(see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) thatcontrol all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require a plete implementation of a full quality management system and the assessment of that system by a third party. Documentation文件In ISO 13485, the requirements in the documentation section relate to the generation and control of documentation (including specifications and procedures) and records.Computers may be used in laboratories for direct and indirect collection, processing and/or storage of data. Both the hardware and software used for such applications should be controlled.ISO 117371:2006(E)The puter system in use should be identified, both in terms of hardware and software, and any changes ineither of these aspects should be documented and subject to appropriate approval.If calculations are performed by electronic data processing techniques, the software (., spreadsheet calculations) should be validated prior to use and records of this validation should be retained.For software, there should be documentation describing:? applications software run on the puter system。? operations software。? data packages in use.All software should be acceptance tested before being put into service.If puter software is developed inhouse, suitable procedures should be developed to ensure that:? documentation on development, including the source code, is retained。? records of acceptance testing are retained。? modifications to programs are documented。? changes in equipment are documented and formally tested before being put into use.These controls should also be applied to any modification or customizing of mercial software packages. There should be procedures to detect or prevent unauthorized changes to software programs.Software programs that organize, tabulate and/or subject data to statistical or other mathematical procedures,or which otherwise manipulate or analyse the electronically stored data, should permit retrieval of original data entries. Special procedures for archiving puter data are likely to be required and these procedures shouldbe documented.Requirements for control of documents and records are specified in and of ISO 13485:2003, or and of ISO/IEC 17025:2005.Requirements for technical records are specified in and of ISO/IEC 17025:2005.See also ISO 90003 for guidance of the application of quality management systems to puter software. Management responsibility管理職責In ISO 13485, the requirements in the management responsibility section relate to management mitment, customer focus, quality policy, planning, responsibility, authority and munication, and management review.In order that the data obtained from performing bioburden determinations are reliable and reproducible, it is important that the determinations be performed under controlled conditions. Therefore, the laboratory facilities used for the determinations, whether on the site of the manufacturer of the medical device or located at a remote location should be managed and operated in accordance with a documented quality system.The determination of bioburden can involve separate parties, each of whom is responsible for certain elements of the method or procedure. This part of ISO 11737 requires that the party accepting particular responsibilities be defined and that this definition of responsibilities be documented. This definition of authority and responsibility is documented within the quality management system(s) of the identified parties. The party accepting responsibilities for defined elements is required to assign these elements to petent personnel, with petence demonstrated through appropriate training and qualification.If bioburden determinations are performed in a laboratory under the direct management of the manufacturer ofthe medical device, the operation of the laboratory resides within the manufacturer39。s quality management system. If an external laboratory is used, the laboratory should be formally certified against an appropriate International Standard (. ISO/IEC 17025).Any laboratory should be mitted to providing a quality service and this mitment should be documentedas a quality policy. The lines of authority and responsibility within the laboratory organization should be formally established and documented. An individual should be nominated to be responsible for the e