Product Safety

AHJs Use NFPA 790 & 791 to Qualify Labs for Electrical Equipment Field Evaluations

Authorities Having Jurisdiction (AHJs) in the United States have typically used the National Electrical Code, NFPA 70, as the basis for approving electrical equipment installations in the United Sates. Much of the Code relies on having products manufactured and certified by a recognized testing laboratory to consensus-based U.S. product safety standards. In Canada, the AHJs... Read More

For Product Safety Approvals, Uncertified and Improperly-Rated Components Require Surveillance

Electrical/electronic equipment manufacturers often ask if it is acceptable to use uncertified or improperly rated components in their products.  The following Frequently Asked Questions address the implications of using these components for North America product safety approvals.  What is an uncertified component? Any safety critical component that is not certified by a suitably accredited agency... Read More

IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets

The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world.  IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.  Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More

OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment

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... Read More

CE Marking Directives Recast to Align with New Legislative Framework

On March 29, 2014, the European Commission published the recasts of eight CE marking directives. These directives have new reference numbers and are aligned with the rules and responsibilities for CE marking that were published earlier in Decision 768/2008/EU.  Here are three that changed: EMC Directive is now 2014/30/EU (previously 2004/108/EC) Low Voltage Directive (LVD)... Read More