iec62366b报告模板Word格式.docx

1、 2010Test procedure :CB SchemeNon-standard test method.:N/ATest Report Form No. :IEC62366BTest Report Form Originator :TV Rheinland North AmericaMaster TRF :Dated 2011-07Copyright 2011 IEC System for Conformity Testing and Certification of Electrical Equipment （IECEE）, Geneva, Switzerland. All right

2、s reserved.This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the readers interpretation of t

3、he reproduced material due to its placement and context.If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo shall be removed.This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in

4、 accordance with IECEE 02.Test item description :Trade Mark :Manufacturer :Model/Type reference :Ratings :Testing procedure and testing location:CB Testing Laboratory:Testing location/ address :Associated CB Test Laboratory:Tested by （name + signature） :Approved by （+ signature） :Testing procedure:

5、TMP WMTWitnessed by （+ signature） : SMTSupervised by （+ signature） :List of Attachments （including a total number of pages in each attachment）:Summary of testingTests performed （name of test and test clause）:Testing location:Summary of compliance with National DifferencesList of countries addressed:

6、 The product fulfils the requirements of _ （insert standard number and edition and delete the text in parenthesis or delete the whole sentence if not applicable）Copy of marking plateThe artwork below may be only a draft. The use of certification marks on a product must be authorized by the respectiv

7、e NCBs that own these marks.See Part 1 ReportTest item particulars :Classification of installation and use :See IEC 60601-1 Test ReportClinical application :Mode of operation :Surface temperature of applied part :Possible test case verdicts:- test case does not apply to the test object :N/A （Not app

8、licable）- test object does meet the requirement :P （Pass）- test object does not meet the requirement :F （Fail）Testing:Date of receipt of test items :Date（s） of performance of tests :Abbreviations used in the report:- normal condition : N.C.- Single fault condition : S.F.C.- means of Operator protect

9、ion : MOOP- Means of Patient protection : MOPPGeneral remarks:（see Attachment #） refers to additional information appended to the report.（see appended table） refers to a table appended to the report.Throughout this report a point is used as the decimal separator.The tests results presented in this r

10、eport relate only to the object tested.This report shall not be reproduced except in full without the written approval of the testing laboratory.List of test equipment must be kept on file and available for review.Additional test data and/or information provided in the attachments to this report.Thr

11、oughout this report a comma / point is used as the decimal separator.This Test Report contains the general safety requirements as related to the usability of Medical Electrical Equipment. It can only be used together with IEC 60601-1 Test Report and IEC 60601-1-6 Test Report.Name and address of fact

12、ory （ies） :General product information:4PRINCIPLES 4.1.1The MANUFACTURER has established, documented and maintains a USABILITY ENGINEERING PROCESS addressing USER interactions with the MEDICAL DEVICE according to the ACCOMPANYING DOCUMENT4.1.2The USABILITY ENGINEERING PROCESS complies with this stan

13、dard and the acceptance criteria in the USABILITY VALIDATION plan have been met4.1.3Information for SAFETY used as a RISK CONTROL measure has been evaluated according to the USABILITY ENGINEERING PROCESS 4.2The results of the USABILITY ENGINEERING PROCESS are recorded in the USABILITY ENGINEERING FI

14、LE :4.3The USABILITY ENGINEERING PROCESS is scaled-up or scaled-down based on the significance of the modification as determined by the results of the RISK ANALYSIS :5USABILITY ENGINEERING PROCESS5.1The application of the MEDICAL DEVICE is specified in the USABILITY ENGINEERING FILE :Document Refere

15、nce No. in usability engineering file: intended medical indication intended PATIENT population- intended part of the body or type of tissue applied to or interacted with intended USER PROFILE intended conditions of use operating principle5.2The frequently used functions that involve USER interaction

16、 with the MEDICAL DEVICE are recorded in the USABILITY ENGINEERING FILE :5.3.1The MANUFACTURER identified characteristics related to SAFETY that focus on USABILITY See Table 5.3.15.3.2The MANUFACTURER identified known or foreseeable HAZARDS related to USABILITY See Table 5.3.2Reasonably foreseeable

17、sequences or combinations of events involving the USER INTERFACE that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE are identified The SEVERITY of the resulting possible HARM was determined 5.4The MANUFACTURER determined the PRIMARY OPERATING FUNCTIONS and recorded them in t

18、he usability fileThe inputs to the PRIMARY OPERATING FUNCTIONS included frequently used functions and functions related to SAFETY of the MEDICAL DEVICE5.5The MANUFACTURER developed the USABILITY SPECIFICATION See Table 5.55.6The MANUFACTURER prepared a USABILITY VALIDATION planSee Table 5.65.7The MA

19、NUFACTURER designed and implemented the USER INTERFACE as described in the USABILITY SPECIFICATION :See 5.8 and 5.9_5.8The MANUFACTURER verified the implementation of the MEDICAL DEVICE USER INTERFACE design against the requirements of the USABILITY SPECIFICATION 5.9The MANUFACTURER VALIDATED USABIL

20、ITY of the MEDICAL DEVICE according to the USABILITY VALIDATION planIf the acceptance criteria are not met and no further improvements are practicable, the medical benefits outweigh the risk 6ACCOMPANYING DOCUMENTIf provided, the ACCOMPANYING DOCUMENT includes a summary of the application specificat

21、ionIf provided, the ACCOMPANYING DOCUMENT includes a concise description of the ME EQUIPMENT, its operating principles and significant physical and performance characteristics, and intended user profileReference to instructions for use _/page _If provided, the ACCOMPANYING DOCUMENT is written at a l

22、evel consistent with the USER PROFILE.If the ACCOMPANYING DOCUMENT is provided electronically, the USABILITY ENGINEERING PROCESS included consideration of which information also needs to be provided as hard copy or as markings on the MEDICAL DEVICE7Training and materials for trainingWhen training is

23、 required for the safe and effective use of primary operating functions, the ACCOMPANYING DOCUMENT describes the available training optionsWhen training is required, the INTENDED USE and USER PROFILE（S） are the basis for training and training materialTable 5.3.1usability engineering file RESULTS TAB

24、LE: Characteristics related to SAFETYDocument Ref. in usability engineering file Result - RemarksVerdictAn identification of characteristics related to SAFETY that focused on USABILITY was performed according to ISO 14971:2007, Clause 4.2During the identification of characteristics related to SAFETY

25、, the following was considered: application specification, including USER PROFILE（S） frequently used functionsTable 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS Identification of known or foreseeable HAZARDS related to USABILITY according to ISO 14971:2007, Cl. 4.3Th

26、e identification of HAZARDS considers HAZARDS to PATIENTS, USERS and other personsReasonably foreseeable sequences or combinations of events involving the user interface that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE are identifiedThe SEVERITY of the resulting possible HARM was determinedDuring the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered: application spe