60601-1, Electrical Equipment
The Third Edition of the medical electrical standard 60601-1, has been updated to include nearly 500 changes made by Amendment 1. It is now also available in a convenient travel-size of just 5.5"x7"!
ANSI/AAMI ES60601-1:2005, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance is the third edition of the standard that covers any medical device that requires an electrical outlet or a battery. It has come to be known throughout the industry as the “bible” of medical electrical equipment standards.
Click here to view the Table of Contents (pdf)
- 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.)
- Whether you choose the PDF, traditional print, or travel-size format, as of March 2012, you get the consolidated text of 60601-1 and Amendment 1 (60601-1:2005(R) 2012/A1:2012) showing the nearly 500 changes made by the amendment.
Choose your format! |
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Traditional printed version | 60601 Mapping Guide |
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5.5" x 7" sized printed version | |
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Immediate download. |
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CD | |
Price (AAMI Member/List): $220/ $440 |
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Only Need the Amendment? (60601-1:2005(R) 2012/A1:2012 was published in Nov. 2012) |
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Traditional printed version | |
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Immediate download | |
Price (AAMI Member/List): $70/$140 |
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