Clause 11.2.1 43.2 (deviation) There is now an must submit a Oxygen Rich Oxygen Rich optional additional list of equipment Environment environment test if evaluation is and facilities, and a not sufficient for procedure for proving that the conducting this test, product is not an or indicate that they ignition hazard in an cannot perform this oxygen-rich test. environment. This is a unique test that a manufacturer may not have the ability to perform. Clause 15.3.5 21 Mechanical Additional must submit a Rough handling test strength ascending shock list of equipment testing and door and facilities, and a frame shock testing procedure for is included that was conducting this test. not present in the previous standard. Clause 15.4.3.4 None Additional NRTLs need to Lithium batteries evaluation of the determine and lithium batteries is submit details of specified to IEC how it will approach standards. the surveillance issues that this new requirement raises. Note 1: The table lists requirements contained in the Third Edition of AAMI ES60601-1. If you have any questions or comments, you may contact the NRTL Program at or
Clause 11.2.1 Oxygen Rich Environment 43.2 (deviation) Oxygen Rich environment There is now an optional additional test if evaluation is not sufficient for proving that the product is not an ignition hazard in an oxygen-rich environment. This is a unique test that a manufacturer may not have the ability to perform. must submit a list of equipment and facilities, and a procedure for conducting this test, or indicate that they cannot perform this test. Clause 15.3.5 Rough handling test 21 Mechanical strength Additional ascending shock testing and door frame shock testing is included that was not present in the previous standard. must submit a list of equipment and facilities, and a procedure for conducting this test. Clause 15.4.3.4 Lithium batteries None Additional evaluation of the lithium batteries is specified to IEC standards. NRTLs need to determine and submit details of how it will approach the surveillance issues that this new requirement raises. Note 1: The table lists requirements contained in the Third Edition of AAMI ES60601-1. If you have any questions or comments, you may contact the NRTL Program at or
NRTL-letter-for-comparability_UL-60601.docx