IEC模板.docx

1、IEC模板Company：File No. File： 软件验证报告 Revised No. 1软件验证报告公司名称：Company Name:公司地址：Company Address:软件名称：Software Name:版本号：Version number:软件适用范围:Software Applications：软件发布时间:Software release time：标 准：Standard:EN 62304:2006 Medical devicesMedical device software-Software life cycle processes结 论：Result:符合EN

2、62304:2006要求编写Compiled by:(Name/Title/Dept.)日期Date:评审Reviewed by(Name/Title/Dept.) 日期Date: 批准Approved by:(Name/Title/Dept.)日期Date:EN 62304：2006的应用软件预期目的和用途识别的危害的可能来源与处理医疗器械数据有关的危害判定已知和合理可预见的危害已进行的安全性标准验证已进行的风险控制方法软件安全性级别： A级 B级 C级确定软件安全性级别的依据：IEC 62304:2006软件安全性级别要求章和条A级B级C级第四章 全部要求XXX5.1 5.1.1、5.1.

3、2、5.1.3、5.1.6、5.1.7、5.1.8、5.1.9XXX 5.1.5、5.1.10、5.1.11XX 5.1.4X5.2 5.2.1、5.2.2、5.2.4、5.2.4、5.2.6XXX 5.2.3XX5.3 5.3.1、5.3.2、5.3.3、5.3.4、5.3.6XX 5.3.5X5.4 5.4.1XX 5.4.2、5.4.3、5.4.4X5.5 5.5.1XXX 5.5.2、5.5.3、5.5.5XX 5.5.4X5.6 全部要求XX5.7 全部要求XX5.8 5.8.4XXX 5.8.1、5.8.2、5.8.3、5.8.5、5.8.6、5.8.7、5.8.8XX6.1 6.

4、1 XXX6.2 6.2.1、6.2.2、6.2.4、6.2.5XXX 6.2.3XX6.3 全部要求XXX7.1 全部要求XX7.2 全部要求XX7.3 全部要求XX7.4 7.4.1XXX 7.4.2、7.4.3XX第8章 全部要求XXX第9章 全部要求XXXEN 62304：2006Possible test case verdicts: - test case does not apply to the test object : N/A- test object does meet the requirement : Pass (P)- test object does not me

5、et the requirement : Fail (F)4General requirements4.1Quality management systemThe MANUFACTURER of MEDICAL DEVICE SOFTWARE shall demonstrate the ability to provideMEDICAL DEVICE SOFTWARE that consistently meets customer requirements and applicableregulatory requirements.4.2RISK MANAGEMENTThe MANUFACT

6、URER shall apply a RISK MANAGEMENT PROCESS complying with ISO 14971.4.3Software safety classificationa) The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, orC) according to the possible effects on the patient, operator, or other people resulting froma HAZARD to whic

7、h the SOFTWARE SYSTEM can contribute.The software safety classes shall initially be assigned based on severity as follows:Class A: No injury or damage to health is possibleClass B: Non-SERIOUS INJURY is possibleClass C: Death or SERIOUS INJURY is possibleIf the HAZARD could arise from a failure of t

8、he SOFTWARE SYSTEM to behave as specified, theprobability of such failure shall be assumed to be 100 percent.If the RISK of death or SERIOUS INJURY arising from a software failure is subsequentlyreduced to an acceptable level (as defined by ISO 14971) by a hardware RISK CONTROLmeasure, either by red

9、ucing the consequences of the failure or by reducing the probabilityof death or SERIOUS INJURY arising from that failure, the software safety classification maybe reduced from C to B; and if the RISK of non-SERIOUS INJURY arising from a softwarefailure is similarly reduced to an acceptable level by

10、a hardware RISK CONTROL measure, thesoftware safety classification may be reduced from B to A.b) The MANUFACTURER shall assign to each SOFTWARE SYSTEM that contributes to theimplementation of a RISK CONTROL measure a software safety class based on the possibleeffects of the HAZARD that the RISK CONT

11、ROL measure is controlling.c) The MANUFACTURER shall document the software safety class assigned to each SOFTWARESYSTEM in the RISK MANAGEMENT FILE.d) When a SOFTWARE SYSTEM is decomposed into SOFTWARE ITEMS, and when a SOFTWAREITEM is decomposed into further SOFTWARE ITEMS, such SOFTWARE ITEMS shal

12、l inherit thesoftware safety classification of the original SOFTWARE ITEM (or SOFTWARE SYSTEM) unlessthe MANUFACTURER documents a rationale for classification into a different software safetyclass. Such a rationale shall explain how the new SOFTWARE ITEMS are segregated so thatthey may be classified

13、 separately.e) The MANUFACTURER shall document the software safety class of each SOFTWARE ITEM if thatclass is different from the class of the SOFTWARE ITEM from which it was created bydecomposition.f) For compliance with this standard, wherever a PROCESS is required for SOFTWARE ITEMS of aspecific

14、classification and the PROCESS is necessarily applied to a group of SOFTWAREITEMS, the MANUFACTURER shall use the PROCESSES and TASKS which are required by theclassification of the highest-classified SOFTWARE ITEM in the group unless theMANUFACTURER documents in the RISK MANAGEMENT FILE a rationale

15、for using a lowerclassification.g) For each SOFTWARE SYSTEM, until a software safety class is assigned, Class Crequirements shall apply.5Software development PROCESS5.1Software development planning5.1.1Software development planThe MANUFACTURER shall establish a software development plan (or plans) f

16、or conducting theACTIVITIES of the software development PROCESS appropriate to the scope, magnitude, andsoftware safety classifications of the SOFTWARE SYSTEM to be developed. The sOFTWAREDEVELOPMENT LIFE CYCLE MODEL shall either be fully defined or be referenced in the plan (orplans). The plan shal

17、l address the following:a) the PROCESSES to be used in the development of the SOFTWARE SYSTEM (see Note 4);b) the DELIVERABLES (includes documentation) of the ACTIVITIES and TASKS;c) TRACEABILITY between SYSTEM requirements, software requirements, SOFTWARE SYSTEMtest, and RISK CONTROL measures imple

18、mented in software;d) software configuration and change management, including SOUP CONFIGURATION ITEMS andsoftware used to support development; ande) software problem resolution for handling problems detected in the SOFTWARE PRODUCTS,DELIVERABLES and ACTIVITIES at each stage of the life cycle.Class

19、A, B, C5.1.2Keep software development plan updatedThe MANUFACTURER shall update the plan as development proceeds as appropriate. Class A, B, C5.1.3Software development plan reference to SYSTEM design and developmenta) As inputs for software development, SYSTEM requirements shall be referenced in the

20、software development plan by the MANUFACTURER.b) The MANUFACTURER shall include or reference in the software development plan proceduresfor coordinating the software development and the design and development validationnecessary to satisfy 4.1.5.1.4Software development standards, methods and tools p

21、lanningThe MANUFACTURER shall include or reference in the software development plan:a) standards,b) methods, andc) toolsassociated with the development of SOFTWARE ITEMS of class C. Class C5.1.5Software integration and integration testing planningThe MANUFACTURER shall include or reference in the so

22、ftware development plan, a plan tointegrate the SOFTWARE ITEMS (including SOUP) and perform testing during integration. Class B,C5.1.6Software VERIFICATION planningThe MANUFACTURER shall include or reference in the software development plan the followingVERIFICATION information:a) DELIVERABLES requi

23、ring VERIFICATION;b) the required VERIFICATION TASKS for each life cycle ACTIVITY;c) milestones at which the DELIVERABLES are VERIFIED; andd) the acceptance criteria for VERIFICATION of the DELIVERABLES.Class A, B, C5.1.7Software RISK MANAGEMENT planningThe MANUFACTURER shall include or reference in

24、 the software development plan, a plan toconduct the ACTIVITIES and TASKS of the software RISK MANAGEMENT PROCESS, including themanagement of RISKS relating to SOUP. Class A, B, C5.1.8Documentation planningThe MANUFACTURER shall include or reference in the software development plan informationabout

25、the documents to be produced during the software development life cycle. For eachidentified document or type of document the following information shall be included orreferenced:a) title, name or naming convention;b) purpose;c) intended audience of document; andd) procedures and responsibilities for

26、 development, review, approval and modification.Class A, B, C5.1.9Software configuration management planningThe MANUFACTURER shall include or reference software configuration management informationin the software development plan. The software configuration management information shallinclude or ref

27、erence:a) the classes, types, categories or lists of items to be controlled;b) the software configuration management ACTIVITIES and TASKS;c) the organization(s) responsible for performing software configuration management andACTIVITIES;d) their relationship with other organizations, such as software

28、 development or maintenance;e) when the items are to be placed under configuration control; andf) when the problem resolution PROCESS is to be used.Class A, B, C5.1.10Supporting items to be controlledThe items to be controlled shall include tools, items or settings, used to develop the MEDICALDEVICE

29、 SOFTWARE, which could impact the MEDICAL DEVICE SOFTWARE. Class B, C5.1.11Software CONFIGURATION ITEM control before VERIFICATIONThe MANUFACTURER shall plan to place CONFIGURATION ITEMS under documented configurationmanagement control before they are VERIFIED. Class B, C5.2Software requirements ana

30、lysis5.2.1Define and document software requirements from SYSTEM requirementsFor each SOFTWARE SYSTEM of the MEDICAL DEVICE, the MANUFACTURER shall define anddocument SOFTWARE SYSTEM requirements from the SYSTEM level requirements. Class A, B, C5.2.2Software requirements contentAs appropriate to the MEDICAL DEVICE SOFTWARE,