We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data. Test report iec 606011 medical electrical equipment part. Test report iec 606011 medical electrical equipment part 1. Thanks to public domain, you can access pdf versions of all the classics youve always.
This report may consist of more than one report and is valid only with additional or previous issued reports. See iec 606011 national differences list of standards. The use of certification marks on a product must be authorized by the respective ncbs that own these marks. It may not be duplicated without prior written consent of bontek compliance laboratory ltd. This collateral standard to iec 60601 1 specifies general requirements and tests for basic safety. Test report en 60601 1 medical electrical equipment part 1. The test results presented in this report relate only to the object tested.
Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 60601 1 and iec 61010 1 series of standards. This test report form is intended for the evaluation of medical electrical equipment and medical electrical systems used in the home healthcare environment i n accordance with iec 60601111. Iec 606011 is intended to serve as a tool in the risk management. Test methodology all tests were performed in accordance with the procedures documented in the most recent versions of basic standards as referenced by iec 60601 1 2. En 55011 test requirement frequency range 150khz 30mhz class a place of measurement in situ, at customer factory shielded semi anechoic chamber, emc test systems, serial no. Item cpsa0700000 new tests performed name of test and test. The test plan presented in this report relate only to the object to be tested. This is a complimentary broad overview that will mostly cover the united states, canada and.
Mecamedical equipment compliance iec 606011 franklin. The tests results presented in this report relate only to the object tested. Test report iec 6060112 medical electrical equipment. For medical devices, the report covers the iec 606011 base standard, applicable collateral and particular standards, as well as national differences.
Iec 606011 medical design standards for power supplies. Other collateral standards include 60601 1 3, covering radiation protection for diagnostic xray systems, 60601 1 9 relating to environmental design, and 60601 1 11 recently introduced for home healthcare equipment. Iec 606011 ul 26011 test checklist all tests conducted at 90 110 % voltage ratings, except. Part af details the requirements for the ul certification. Aug 07, 2018 iec 606011 third edition amendment 1 ed. Descriptive report and test results the biomat estore. Other collateral standards include 60601, covering radiation protection for diagnostic xray systems, 6060119 relating to. Keystone compliance assists manufacturers with iec 6060116 and en 6060116 test compliance. Products described in this test report must comply with any applicable items listed unless otherwise stated in the body of each test report. This test report form can be used to complement the iec 60601 1 test report. Refer to test report gzme150500045101relevant safety report iec 606011. Att5 iec 606011 test report 1 to 123 att6 iec 6060116 test report 1 to 5 att7 iec 60601111 test report 1 to 30 att8 iec 62366 test report 1 to att9 risk management files 1 to 59 products. Is in line with requirements from iec 606011 according to. Conformity test report product safety medco equipment.
This test report is limited to the above client company and the product model only. En 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Although emc immunity test requirements for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment, and information. Make sure that you obtained this publication from an authorized distributor. Electromagnetic compatibility requirements and tests. The medikzap is a modern, electronic equipment generating a square wave current transferred to the body via two electrodes held. The observations and test results in this report are relevant only to the sample tested. Verify your medical equipment meets iec 60601 1 9 standards on environmentally conscious design. For medical devices, the report covers the iec 60601 1 base standard, applicable collateral and particular standards, as well as national differences.
The test results presented in this report relate only to the item tested. This test report form can be used to complement the iec 60601. Page 2 of 163 report no trs11120147 summary of testing tests performed name of test and test clause. This report shall not be reproduced, except in full, without the written approval of the. Test report en 60601 1 medical electrical equipment part. We meet the expense of test report iec 60601 1 2 medical electrical equipment and numerous book collections from fictions to scientific research in any way. Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 606011 and iec 610101 series of. Iec 606011 is intended to serve as a tool in the risk management process. More work to be done before sending device to the test house. Conformity test report product safety according to iecen 606011 2nd edition safety requirements for medical electrical equipment test report no r11cs6s issue date. This report shall not be reproduced except in full, without the written approval of ul verification services inc. Although emc immunity test requirements for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment, and information technology equipment, basic standard. Iec 606011 medical design standards for power supplies cui inc. Test report iec 60601 1 2 medical electrical equipment.
See iec 60601 1 national differences list of standards. This report by itself does not imply that the material, product, or service is or has ever. Verify your medical equipment meets iec 6060119 standards on environmentally conscious design. Na k power output of auxiliary mains socketoutlets na l class ii symbol na. The power supplies were tested on a 20 a branch circuit.
While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. Ul test report and procedure artesyn embedded power. General requirements for basic safety and essential performance. Att5 iec 60601 1 test report 1 to 123 att6 iec 60601 1 6 test report 1 to 5 att7 iec 60601 1 11 test report 1 to 30 att8 iec 62366 test report 1 to att9 risk management files 1 to 59 products class 8780 01 medical electrical equipment canadian adopted iec 60601 1 3rd edition. Test methodology all tests were performed in accordance with the procedures documented.
Test report iec 610101 safety requirements for electrical. 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. En 60601 or iec 60601 is the european harmonized standard to meet the medical device directive. Test report en 606011 medical electric equipment part 1. En 60601 applies to the basic safety and essential performance of medical electrical. Iec 6060112 4th edition emc nicholas abbondante chief engineer, emc. Iec 60601 is a series of technical standards that ensure the safety of medical electrical equipment. Keystone compliance assists manufacturers with iec 60601 1 6 and en 60601 1 6 test compliance. Trf iec 606011h medical electrical equipment part 1 invacare. Test report iec 60601 1 medical electrical equipment part 1. For laboratory equipment, the report covers the iec 61010 1 base standard and applicable particular standards. More than 80 percent of hospitals around the globe. Iec 606011 for medical electrical equipment tuv sud. Test report iec 6060112 medical electrical equipment part 1.
Table 10 minimum test report contents 1 of 2 41 table a. Missing page numbers correspond to the frenchlanguage pages. Please contact us for more information on how keystone compliance can assist you with identifying. Iec 60601 1 2 requires that the performance criteria address all essential functions of the medical device. This is a complimentary broad overview that will mostly cover the united states, canada.