IEC60601-1-6检查表英文版.docVIP

IEC 60601-1-6 Page PAGE 1 of NUMPAGES 5 Commission Electrotechnique InternationaleInternational Electrotechnical CommissionSecretary IEC/SC 62D Commission Electrotechnique Internationale International Electrotechnical Commission Secretary IEC/SC 62D STRATEGIC DEVICE COMPLIANCE SERVICES Global Safety, Regulatory and Standards Compliance Services IEC 60601 - 1- 6 Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability Report Reference No. : FORMTEXT Compiled by (+ signature) : Approved by (+ signature) : Date of issue : Applicant’s name : Address :  Test specification: Standard : IEC?606011-6: 2006 Test item description : Trade Mark : Manufacturer : Model/Type reference : Ratings : Possible 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 meet the requirement : Fail (F) Commission Electrotechnique InternationaleInternational Electrotechnical CommissionSecretary IEC/SC 62D Commission Electrotechnique Internationale International Electrotechnical Commission Secretary IEC/SC 62D STRATEGIC DEVICE COMPLIANCE SERVICES Global Safety, Regulatory and Standards Compliance Services Clause Requirement + Test Result - Remark P/F/NA 4 General requirements 4.1 Equipment provides adequate usability, and the risks resulting from normal use and use errors are acceptable 4.2 Risk analyses shall incorporate/consider the following: – application specification – OPERATOR PROFILE; – predictable USE ERRORS – * task related requirements; – * context of use; – information on HAZARDS known for existing OPERATOR-EQUIPMENT INTERFACES for ME EQUIPMENT of a similar type – results of the review of the OPERATOR-EQUIPMENT INTERFACE 5 Identification, marking and documents 5.1 Accompany