Transcription of A Practical Guide to IEC 60601 - Rigel Medical
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A Practical Guide to IEC 60601 - Rigel Medical
A Practical Guide to IEC Medical PG 2 TESTED, WORLDWIDE. Copyright 2019 - All rights reserved. Nothing from this edition may be multiplied, or made public in any form or manner, either electronically, mechanically, by photocopying, recording, or in any manner, without prior written consent from Seaward Electronic Ltd. This also applies to accompanying drawings and to IEC 6060104 Local adaptation05 Commonly used definitions within IEC 6060106 Symbols and markings07 Visual inspection07 Earth bond (protective earth) testing08 Leakage measurements10 IEC 60601 -1 body model10 Single fault condition10 Earth leakage test11 Enclosure leakage test12 Patient leakage13 Patient leakage F-Type13 Patient auxiliary current14 Record keeping14 Conclusion16 Appendix A - IEC 60601 -1 test limits17 Appendix B - IEC 60601 body model17 Appendix C - IEC 60601 test standards (Table 1)18 Appendix D - IEC 60601 test standards (Table 2)24 Appendix E - Patient environment25 Products in the Rigel M
been adapted into local standards for use in countries around the world. Some examples are EN 60601 (EU), ANSI/AAMI ES60601 (USA), UL60601-1 (USA), CSA C22.2 no 60601-1 (Canada), JIS T 0601-1 (Japan) and AS/NZ 60601.1 (Australia/New Zealand). Safety testing at the design stage and at the
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