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About This Item
Full Description
- Includes a risk management model - based on ANSI/AAMI/ISO 14971
- Introduces the concept of essential performance - a measure of a device's effect on user and patient safety
- Offers flexibility in meeting requirements, for example, different requirement levels for parts that come into contact with the user vs. parts that come in contact with the patient.
- Provides structured method for manufacturers to demonstrate equivalent safety of alternate means of compliance
- Identical to IEC 60601-1 but with U.S. deviations to comply with U.S. National Electric Code. (IEC text is also included for reference.)
Document History
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AAMI ES60601-1: 2005 & A1:2012 & A2:2021
Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION- Most Recent
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AAMI ES60601-1:2005/(R)2012 (Consolidated Text)
Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), Consolidated Text of ES60601-1:2005/(R)2012 and A1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012- Historical Version
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AAMI ES60601-1:2005/(R)2012
Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Consolidated Text- Historical Version
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AAMI ES60601-1:2005 and ES60601-1:2005/C1:2009
Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)- Historical Version
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AAMI ES60601-1:2005
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Medical electrical equipment, Part 1: General requirements for basic safety and essential performance- Historical Version
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AAMI ES1-1993
Safe Current Limits for Electromedical Apparatus- Historical Version