Product Safety

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

IT Equipment Compliance to IEC 60950 for Taiwan BSMI Requires Additional I/O Port Testing

For a manufacturer looking to add Taiwan to its information technology equipment homologations program, a BSMI approval is required.  Therefore, testing supplemental to typical IEC 60950 certification is necessary.  Standard compliance with IEC 60950 allows for the waiver of testing of I/O ports if they are sourced from a SELV (safety extra low-voltage) and/or power... Read More

CCC Certification for Product Safety & EMC Required for China Market Entry

China is fast becoming the largest consumer market in the world, and for many products, China Compulsory Certification (CCC) is necessary for manufacturers to tap this market. Certification Bodies There are three main certification bodies (CBs) for electronic equipment: China Quality Certification Center (CQC) – issues all electronic equipment CCC certificates China Information Security Certification... Read More