iec60601_2_37e

iec60601_2_37e TEST REPORT IEC 60601-2-37 Medical electrical equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Report Reference No. ................... : Date of issue ................................... : Total number of pages .................... : CB Testing Laboratory ................. : Address .......................................... : Applicant’s name .......................... : Address .......................................... : Test specification: Standard ......................................... : IEC 60601-2-37:2007 for use in conjunction with IEC 60601-1:2005 Test procedure ................................ : CB Scheme Non-standard test method…………..: N/A IEC60601_2_37E Test Report Form No. ................... : Test Report Form(s) Originator ....... : Underwriters Laboratories Inc. Master TRF..................................... : Dated 2010-10 Copyright ? 2010 Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE), Geneva, Switzerland. All rights 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 reader's interpretation of the reproduced material due to its placement and context. If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB Scheme procedure 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 accordance with IECEE 02. Test item description .................... : Trade Mark ..................................... : Manufacturer .................................. : Model/Type reference ..................... : Ratings ........................................... : Page 2 of 16 Report No. List of Attachments (including a total number of pages in each attachment): Summary of testing: Tests performed (name of test and test Testing location: clause): Summary of compliance with National Differences List of countries addressed: 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) Page 3 of 16 Report No. Copy of marking plate The artwork below may be only a draft. The use of certification marks on a product must be authorized by the respective NCBs that own these marks. Page 4 of 16 Report No. Test item particulars ............................................. : Classification of installation and use ....................... : See IEC 60601-1 Test Report Clinical application of ULTRASONIC DIAGNOSTIC soft tissue; bone-cranial; multi-purpose; EQUIPMENT ............................................................. : cephalic; trans-oesophageal; intra-corporal neonatal; foetal; paediatric; adult; MODE of operation ................................................... : non-scanning mode; scanning mode; combined- operating mode 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) Testing: Date of receipt of test items ..................................... : Date(s) of performance of tests ................................ : General remarks: The test results presented in this report relate only to the object tested. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. "(see Enclosure #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report. Throughout this report a comma / point is used as the decimal separator. This Test Report Form contains the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment according to IEC 60601-2-37. It can only be used together with IEC 60601-1 Test Report. Manufacturer’s Declaration per sub-clause 6.2.5 of IECEE 02: The application for obtaining a CB Test Yes Certificate includes more than one factory Not applicable location and a declaration from the Manufacturer stating that the sample(s) submitted for evaluation is (are) representative of the products from each factory has been provided ................... : When differences exist; they shall be identified in the General product information section. Name and address of factory (ies) ........................ : Page 5 of 16 Report No. General product information: Page 6 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict 201.4 GENERAL REQUIREMENTS 201.4.3.101 Table 201.102 applied to the potential sources of Essential performance addres unacceptable risk identified to characterize the sed as part of the RM effort; s ESSENTIAL PERFORMANCE of ULTRASONIC ISK MANAGEMENT Table 2ee RDIAGNOSTIC EQUIPMENT 01.10.101 for results 201.7 IDENTIFICATION, MARKING AND DOCUMENTS 201.7.2.9 Marking of the IPX code on the transducer assembly is not required, for partial IPX classification of the transducer assembly 201.7.2.13 Physiological effects Description of means used to limit the surface heating of ULTRASONIC INVASIVE TRANSDUCER ASSEMBLIES to no more than 43 ?C in the event of single fault condition 201.7.2.101 Acoustic output Action to directly increase or decrease output levels is clear to the OPERATOR of ULTRASONIC DIAGNOSTIC EQUIPMENT capable of generating output levels subject to 201.12.4.2 This marking is an active DISPLAY THERMAL and MECHANICAL INDICES displayed per 51.2 together with declaration of accuracy per 201.7.9 and 201.12 .......................................... : Ultrasound output level display is clearly visible from the OPERATOR’S position with name(s) or abbreviation(s) of the index (indices) displayed : 201.7.9.2.2 Warning and safety notices Information on how to interpret the displayed ultrasonic exposure parameters, THERMAL INDEX (TI) and MECHANICAL INDEX (MI) according to annex CC Procedure necessary for safe operation, pointing out possible safety hazards due to inadequate electrical installation when APPLIED PART of ULTRASONIC DIAGNOSTIC EQUIPMENT is TYPE B Information on safe use of TRANSDUCER ASSEMBLIES indicating ULTRASONIC DIAGNOSTIC EQUIPMENT is of the correct type for its intended application - Warning against activation of TRANSDUCER ASSEMBLY intended for intra-corporeal use outside PATIENT’S body if TRANSDUCER ASSEMBLY does not comply with EMC requirements (may cause harmful interference with other equipment) Page 7 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict - Identification of interference with other equipment and mitigation techniques included in the INSTRUCTIONS FOR USE when a reduction in test levels is claimed by the MANUFACTURER A notice that the ULTRASONIC DIAGNOSTIC EQUIPMENT or parts are provided with protective means against burns to PATIENT when used with HF surgical equipment - ACCOMPANYING DOCUMENTS caution against lack of protective means, and describe location and use of TRANSDUCER ASSEMBLY to reduce hazard of burns in the event of a defect in HF surgical neutral electrode connection A PRUDENT-USE STATEMENT for ULTRASONIC DIAGNOSTIC EQUIPMENT capable of generating output levels subject to 201.12.4.2 Descriptions of DISPLAYS and means OPERATOR may use to modify operation of EQUIPMENT relevant to ultrasound output Description of DISPLAYS and means OPERATOR may use to modify operation of EQUIPMENT relevant to surface temperature for INVASIVE TRANSDUCER ASSEMBLIES intended for trans- oesophageal use A description of TRANSDUCER ASSEMBLY parts which may be immersed in water or other liquids for NORMAL USE or performance assessment purposes A recommendation calling the OPERATOR’S attention to the need for regular testing and periodic maintenance including inspection of the TRANSDUCER ASSEMBLY for cracks which allow the ingress of conductive fluid Instructions regarding the avoidance of unintended control settings and acoustic output levels Output limits selected according to 201.12.4.5.1 declared, and output limits declared for each application for MULTI PURPOSE ULTRASONIC EQUIPMENT 201.7.9.2.10 List of all system messages, error messages and fault messages unless these messages are self- explanatory 201.7.9.2.12 List of the pertinent parts, components and/or functions that should be checked after each cleaning, disinfection or sterilization cycle, and method(s) of inspection. Page 8 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict 201.7.9.3 Technical description 201.7.9.3.10aa) OPERATOR’S manual includes technical data 1 on acoustic output levels .................................. : For each mode the Acoustic Output Reporting Table provides the maximum value of each index For a TRANSDUCER ASSEMBLY and ultrasound instrument console satisfying all of the exemption conditions cited in 201.12.4.2 a) & b), information declared in the ACCOMPANYING DOCUMENTS that the THERMAL INDICES and the MECHANICAL INDEX are below 1.0 for all device settings. 201.8 PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT 201.8.7.4.7 aa) The TRANSDUCER ASSEMBLY tested with the APPLIED PART immersed in a 0.9 % saline solution 201.8.7.4.8 The TRANSDUCER ASSEMBLY tested with the APPLIED PART immersed in a 0.9 % saline solution 201.8.8.3 The TRANSDUCER ASSEMBLY tested with the APPLIED PART immersed in a 0.9 % saline solution 201.8.9.3.4 Thermal cycling 201.8.10.4 Requirements of cord-connected HAND-HELD parts and cord-connected foot-operated control devices are not applied to ULTRASONIC TRANSDUCER ASSEMBLIES 201.10 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZAR DS 201.10.101 Ultrasonic energy RISKS associated with ultrasonic energy in the See RISK MANAGEMENT Table RISK MANAGEMENT PROCESS is addressed by 201.10.101 MANUFACTURER Acoustic output switched off when image freeze facility is enabled 201.11 PROTECTIVE AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZAR DS 201.11.1.2.2 Contact surface temperature of TRANSDUCER See Table 201.11.1.3 ASSEMBLY measured under test conditions of 201.11.1.3.1.1 did not exceed 43 (:C) .............. : Page 9 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict Contact surface temperature of TRANSDUCER See Table 201.11.1.3 ASSEMBLY measured under test conditions of 201.11.1.3.1.2 did not exceed 50 (:C) .............. : 201.11.1.3 Compliance with the requirements of 11.1.1 and ISK MANAGEMENT Table See R 11.1.2 is checked by inspection of the RISK 201.11.1.3 MANAGEMENT FILE 201.11.1.3.1.Simulated use 1 For TRANSDUCER ASSEMBLY intended for external use, thermal and acoustical properties mimicking those of a skin layer For soft tissue, the material of TRANSDUCER ASSEMBLY has specific heat capacity, thermal conductivity, and special attenuation at 5 MHz . : For TRANSDUCER ASSEMBLY intended for external See Table 201.11.1.3 use, the initial temperature of the surface at the object-transducer interface was not less than 33?C at ambient 23 ?C ? 3?C when using test method a) (:C) ................................................. : For INVASIVE TRANSDUCER ASSEMBLY, the initial See Table 201.11.1.3 temperature of the surface at the object- transducer interface was not less than 37?C at ambient 23 ?C ? 3?C when using test method a) (:C) .................................................................. : Initial temperature of surface test object See Table 201.11.1.3 measured using method b) of this sub-clause was not less than the ambient temperature of 23?3 (:C) ............................................................. : The surface of the APPLIED PART did not exceed 43 ?C For TRANSDUCER ASSEMBLIES intended for See Table 201.11.1.3 external use, the initial temperature of the surface of the test object at the object transducer interface was between 20? C and 33? C, and the surface temperature rise of the APPLIED PART did not exceed 10 ?C For INVASIVE TRANSDUCER ASSEMBLIES, the initial temperature of the surface of the test object at the object-transducer interface was between 20?C and 37?C, and the surface temperature rise did not exceed 6 ?C For TRANSDUCER ASSEMBLIES intended for See Table 201.11.1.3 external use, the temperature measured under the test conditions of 201.11.1.3.1.1 method b) was equal to the sum of 33 ?C plus the measured temperature rise (?C) ....................... : Page 10 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict For INVASIVE TRANSDUCER ASSEMBLIES the See Table 201.11.1.3 temperature measured under the test conditions of 201.11.1.3.1.1 method b) was equal to the sum of 37 ?C plus the measured temperature rise (?C) ........................................................... : The calculated temperature did not exceed 43?C 201.11.1.3.1.Still air 2 Initial temperature of radiating surface of TRANSDUCER ASSEMBLY was equivalent to the ambient temperature of 23 ? 3 (:C) .................. : Temperature rise of radiating surface of See Table 201.11.1.3 TRANSDUCER ASSEMBLY did not exceed 27 (:C) .. : To meet the requirements of not exceeding a surface temperature of 50 ?C, sum of the surface temperature rise obtained under test conditions of this sub-clause and 23 :C was regarded as the surface temperature (:C) .................................. : 201.11.1.3.2 Tests 201.11.1.3.1.1 and 201.11.1.3.1.2 of this See Table 201.11.1.3 sub-clause conducted using transmit parameters with ULTRASONIC DIAGNOSTIC EQUIPMENT operating at a setting for the highest surface temperature (:C) .................................................................. : Transmit parameters recorded in the RISK ISK MANAGEMENT Table See R MANAGEMENT FILE201.11.1.3.2 ............................................. : 201.11.1.3.3 Test according to 201.11.1.3.1.1 conducted with ULTRASONIC DIAGNOSTIC EQUIPMENT operating continuously for 30 min Test according to 201.11.1.3.1.2 conducted for 30 min or twice the time period limited by an automatic output freezing capability, whichever was shorter (minutes) ....................................... : 201.11.1.3.4 Surface temperature of TRANSDUCER ASSEMBLY measured on areas having achieved highest surface temperature Measurement uncertainty recorded in the RISK ISK MANAGEMENT Table See R MANAGEMENT FILE .............................................. : 201.11.1.3.4 201.11.1.3.5 Test criteria and conditions required by sub- clause 201.11.1.3 were according to Table 201.104 201.11.6.5 Parts of TRANSDUCER ASSEMBLY likely to come into contact with OPERATOR or PATIENT meet the requirements of DRIP-PROOF EQUIPMENT (IPX1) This requirement not applied to connectors of TRANSDUCER ASSEMBLY Page 11 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict Parts of TRANSDUCER ASSEMBLY intended to be immersed in NORMAL USE meet the requirements of WATERTIGHT EQUIPMENT (IPX7) 201.12 ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTION AGAINST HAZARDOUS OUTPUTS 201.12.1 Accuracy of data and controls unique to acoustic output are specified, including - Accuracy of display indicating the THERMAL INDEX (TI) and MECHANICAL INDEX (MI) (201.7.9.2.2, 201.7.2.101 and 201.12.4.2.) ....... : - Technical data (201.7.9.3.101) ....................... : Accuracy of data and controls unique to surface temperature of ULTRASONIC TRANSDUCER intended for trans-esophageal use is specified and includes accuracy of any display of surface temperature ..................................................... : 201.12.4.2 c) For EQUIPMENT capable of exceeding SOFT TISSUE or BONE THERMAL INDEX of 1.0, in any mode, OPERATOR can display, but not simultaneously, both the SOFT TISSUE INDEX (TIS) and BONE THERMAL INDEX (TIB) (when a value of 0.4 is exceeded) d) THERMAL INDEX display for EQUIPMENT intended only for adult cephalic applications includes only the CRANIAL-BONE THERMAL INDEX when ,1.0 e) MECHANICAL INDEX , 0.4 displayed for EQUIPMENT capable of exceeding MECHANICAL INDEX of 1.0 in real-time B-mode operation (when no other mode is active) f) OPERATOR can display both THERMAL and MECHANICAL INDICES, simultaneously g) The increments for the display of THERMAL INDICES, if display required, are no more than 0.2 over the entire range h) Increment for each display of MECHANICAL INDICES is no more than 0.2 over the entire range i) For trans-oesophageal ULTRASONIC TRANSDUCERS, capable of exceeding 41:C on surface temperature, a display or other means indicate when surface temperatures is over 41 :C ........................................................................ : Page 12 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict 201.12.4.3 a) ULTRASONIC DIAGNOSTIC EQUIPMENT, allowing FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUT, switches to an appropriate DEFAULT SETTING upon power-up, entry of new PATIENT identification data, or change from a non-foetal to a foetal application DEFAULT SETTING levels established by the MANUFACTURER but can be changed by OPERATOR b) In MULTI-PURPOSE ULTRASONIC DIAGNOSTIC EQUIPMENT, without FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUT, means provided to remind OPERATOR to verify or change acoustic output and MECHANICAL and/or THERMAL INDEX displayed .. : 201.12.4.5.1 Limits Acoustic output is limited based on RISK ISK MANAGEMENT Table See R ASSESSMENT and RISK MANAGEMENT following ISO 201.12.4.5.1 14971 using the safety related parameters specified in this standard and other relevant information such as clinical experience. 201.17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND ME SYSTEMS See Enclosure No._ for IEC 6 ULTRASONIC DIAGNOSTIC EQUIPMENT complied with 0601-1-2 Report IEC 60601-1-2, as modified in 202.6 202.6 ELECTROMAGNETIC COMPATIBILITY See Enclosure No._ for IEC 6 ULTRASONIC DIAGNOSTIC EQUIPMENT complied with 0601-1-2 Report IEC 60601-1-2, except as follows: 202.6.1.1.1 ULTRASONIC DIAGNOSTIC EQUIPMENT classified as Group 1 and Class A or B based on CISPR 11 and based on its intended use as specified in INSTRUCTIONS FOR USE. ..................................... : 202.6.2.1.10 IMMUNITY complied with IEC 60601-1- 2 and modifications indicated in this subclause a nd subclauses 202.6.2.3 and 202.6.2.6 202.6.2.7 a) ULTRASONIC DIAGNOSTIC EQUIPMENT complied with the requirements of 202.6.2.10 at the IMMUNITY TEST LEVELS specified in Table 10 of IEC 60601-1-2 ULTRASONIC DIAGNOSTIC EQUIPMENT remained safe with no component failures and was restored to pre-test state by the OPERATOR when requirements of 202.6.2.10 and IMMUNITY TEST LEVELS specified in Table 10 of IEC 60601-1-2 were deviated Page 13 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict Deviations from IMMUNITY TEST LEVELS for voltage dips specified in Table 10 of IEC 60601-1-2 ...... : Page 14 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict 201.10.101 RM RESULTS TABLE: Protection against unwanted and excessive radiation hazards Clause of Document Ref. in RMF Result - Remarks Verdict ISO 14971 (Document No. & paragraph) 4.2 4.3 4.4 5 6.2 6.3 6.4 6.5 6.6 201.11.1.3 TABLE: Excessive Surface Temperatures Supply voltage ................................: Final Radiating TMM Initial Ambient Surface Temp. (TF) Ultrasound Transducer (Method A Operating Condition Temp. and/or System Model or B) or (Mode) (:C) (:C) Still Air Temp. Rise (TR), (:C) TF = TR = TF = TR = TF = TR = TF = TR = TF = TR = TF = TR = Supplementary information: Page 15 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict 201.11.1.3 RM RESULTS TABLE: Excessive Surface Temperatures Clause of Document Ref. in RMF Result - Remarks Verdict ISO 14971 (Document No. & paragraph) 4.2 4.3 4.4 5 6.2 6.3 6.4 6.5 6.6 201.11.1.3.RM RESULTS TABLE: Transmit parameters 2 Clause of Document Ref. in RMF Result - Remarks Verdict ISO 14971 (Document No. & paragraph) 4.2 201.11.1.3.RM RESULTS TABLE: Measurement uncertainty 4 Clause of Document Ref. in RMF Result - Remarks Verdict ISO 14971 (Document No. & paragraph) 4.2 201.12.4.5.RM RESULTS TABLE: Acoustic output limits 1 Clause of Document Ref. in RMF Result - Remarks Verdict ISO 14971 (Document No. & paragraph) 4.2 4.3 4.4 5 6.2 6.3 6.4 6.5 6.6 Page 16 of 16 Report No. IEC 60601-2-37 Clause Requirement + Test Result - Remark Verdict