60601-1, 3rd Edition, Medical electrical equipment, Part 1
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.
- 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.
Published: March 2006; Reaffirmed January 2012; 402 pages.
|Product Code||Format||List Price||Member Price|
|606011-PE||5.5"x7" Travel Size||$999||$586|