Table 1. List of Requirements in AAMI ES60601-1 that substantially differ from UL 60601-1 AAMI ES60601-1 UL Significance of Information Section(s) or Requirements Difference NRTLs Need to Clause(s) Submit (See Note 1) Clause 9.6 Acoustic None Acoustic testing is NRTLs must submit Energy present in other a list of equipment standards but data and facilities, and sheets / procedures procedures for need to be adapted conducting this test. for this testing. Clause 9.7.2 - .4 None Functional pressure must submit a Pressure vessels and testing will be list of equipment parts subject to unique for each and facilities, and a pneumatic and product but must be procedure for hydraulic pressure addressed per this conducting this test. clause. Clause 9.7.6 None This is a unique test must submit a Pressure control and OSHA is not list of equipment device aware of any other and facilities, and a standards where procedure for such a cycling test conducting this test. for pressure relief / control valves is necessary. Clause 9.8 28.4 Suspension This is a unique NRTLs must submit Mechanical hazards systems of metal mechanical test. a list of equipment associated with without safety and facilities, and a support systems devices. procedure for conducting this test.
Table 1. List of Requirements in AAMI ES60601-1 that substantially differ from UL 60601-1 AAMI ES60601-1 Section(s) or Clause(s) (See Note 1) UL Requirements Significance of Difference Information NRTLs Need to Submit Clause 9.6 Acoustic Energy None Acoustic testing is present in other standards but data sheets / procedures need to be adapted for this testing. NRTLs must submit a list of equipment and facilities, and procedures for conducting this test. Clause 9.7.2 - .4 Pressure vessels and parts subject to pneumatic and hydraulic pressure None Functional pressure testing will be unique for each product but must be addressed per this clause. must submit a list of equipment and facilities, and a procedure for conducting this test. Clause 9.7.6 Pressure control device None This is a unique test and OSHA is not aware of any other standards where such a cycling test for pressure relief / control valves is necessary. must submit a list of equipment and facilities, and a procedure for conducting this test. Clause 9.8 Mechanical hazards associated with support systems 28.4 Suspension systems of metal without safety devices. This is a unique mechanical test. NRTLs must submit a list of equipment and facilities, and a procedure for conducting this test.
NRTL-letter-for-comparability_UL-60601.docx