Product Safety
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
Product Safety Professionals Meet at ICPHSO to Discuss Changes in 2014
This week, the nation’s top product safety organization – ICPHSO – is meeting for the 21st time, at its 2014 Annual Meeting and Training Symposium in Orlando, FL. MET Labs is participating as an exhibitor and sponsor. There were a number of interesting sessions on product safety regulations, compliance, and legal issues. George Borlase, Consumer... Read More
Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2013
The Compliance Today blog for electrical product manufacturer compliance engineers saw a significant jump in readers and subscribers in 2013. Following were the most popular 2013 posts, by pageviews. EN 61010-1 3rd Edition Compliance Required in EU by October 2013 FAQs Regarding IEC 62368-1, the Replacement for IEC 60950-1 & IEC 60065 Russia GOST R... Read More
IEC 62368-1 Edition No. 2 Draft Is Released
The First Draft International Standard (FDIS) for Edition 2.0 of IEC 62368-1 was published last month. The FDIS is the final voting stage before a standard is released as an International Standard (IS). IEC 62368-1 is a hazard-based, performance-oriented standard for IT equipment and A/V equipment, intended to replace IEC 60950-1 and IEC 60065. Read about... 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
Amendment 2 of IEC 60950-1 Edition 2 Has a Few Notable Changes from Amendment 1
Amendment No. 2 to IEC 60950-1 Second Edition, Safety of Information Technology Equipment, was published in May 2013. The differences as compared to Amendment 1 (and UL 60950-1 2nd Edition) are mostly minor, but there are a few notable changes. Note that IEC Technical Committee (TC) 108 has made a commitment to limit revisions to... Read More
