After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program.
In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards. This version of the standard is the U.S. National Version of IEC 60601-1 + A1.
OSHA delayed NRTL recognition for the U.S. version of IEC 60601-1:2005 (3rd edition) due to what it saw as subjective compliance requirements, as well as statements in the standard that would have required the NRTL to accept statements from the manufacturer without the ability for the NRTL to verify the validity of these statements.
The changes in language introduced in Amendment 1 (496 changes for the IEC standard) allows the NRTL to verify the validity of data accepted from the manufacturer.
Here are some of the key changes in AAMI ES60601-1 as compared to UL 60601-1:
- Clause 9.6 Acoustic Energy – Not included in UL 60601-1
- Clause 9.7.2-.4 Pressure vessels and parts subject to pneumatic and hydraulic pressure – Not included in UL 60601-1
- Clause 9.7.6 Pressure control device – Not included in UL 60601-1
- Clause 9.8 Mechanical hazards associated with support systems – This is a unique mechanical test not included in UL 60601-1
- Clause 11.2.1 Oxygen Rich Environment – An optional additional test if evaluation is not sufficient for proving that the product is not an ignition hazard in an oxygen-rich environment
- Clause 15.3.5 Rough handling test – Additional ascending shock testing and door frame shock testing is included that was not present in UL 60601-1
- Clause 126.96.36.199 Lithium batteries – Not included in UL 60601-1
MET Labs is OSHA-recognized for UL 60601-1, and is expecting to soon be recognized for ANSI/AAMI ES60601-1:2005/(R)2012 as well. Contact us for a free fast-response quote for electro-medical equipment testing and certification for any major market.