Welcome to the inaugural edition of G&M Compliance newsletter. The goal of this quarterly publication is to provide you, our colleague in regulatory compliance, with information that is practical, relevant, and pertinent to the fields of product safety, EMC/EMI, and overall regulatory compliance. Not only will we try to provide accurate and timely information with respect to coming requirements, but we look forward to sharing with you some of the knowledge that we have gained all these many years of participating in our field. We may, at times, encourage discussions about regulatory requirements as well as express our opinions on the future of our industry. And, finally, we hope to highlight the services that G&M Compliance provides.
But first, at little about us: Since 1997, G&M Compliance has been committed to making the certification process simple! With over 70 years of combined experience, we are experts in regulatory compliance of various types of electrical equipment such as information technology equipment, laboratory equipment, and medical devices. Our team of regulatory compliance professionals can assist you in obtaining NRTL certification such as UL, CSA, or TUV, as well as guiding you through international certification schemes such as CCC (China), CE (Europe), CB, GOST (Russia), and many others. For more information, please visit our website at www.gmcompliance.com.
IMPORTANT REMINDER: Effective January 24, 2013, the European Union will require products placed on the market to comply with EN 60950-1:2006/ A11:2009/ A12:2011 and effective March 1, 2013, A1:2010 will also be required. In addition, for UL/CUL certification, effective March 1, 2013, UL will certify new products and products with significant changes, to CSA/UL 60950-1 Second Edition, dated December 19, 2011. In order to prevent any certification delays or challenges to your declarations we recommend that you update your certifications or type approval documentation to IEC 60950-1:2005/A1:2009, EN 60950-1:2006/A11:2009 / A1:2010 /A12:2011 and CAN/CSA-C22.2 No. 60950-1-07/UL60950-1 dated December 19, 2011, as applicable.
SAFETY MEDICAL DEVICE STANDARD: The IEC 60601-1 standard is a globally recognized standard for electro-medical equipment safety, and a parent standard over 60 particular device standards. The third edition (3rd), issued in 2005, has a compliance date of June 2012 for the European market (EN 60601-1:2006), and July 2013 for the US market under FDA (ANSI/AAMI ES60601-1:2005), and is radically different from the preceding, second edition (2nd) standard.
IEC have recently published the Amendment 1 on July 13, 2012, with EN standard ratification from CENELEC soon following on October 1, 2012.
One addition is a clause to conform to the ISO14971 regulations for risk management. This ISO regulation establishes requirements for the manufacturer to employ risk management in determining the safety of a medical device during its product life cycle. IEC 60601-1, 3rd Edition has several other updated regulations concerning: general requirements for medical devices; standards for identification, marking and providing accompanying documents; hazards (electrical, mechanical, radiation, temperature and fire, accuracy, etc.); and hazardous situations and fault conditions. The purpose of these rules is to ensure that equipment manufacturers have safety, performance, and risk management control measures in place.
CHINA CCC ITE STANDARD UPDATE: The CCC standard GB4943-Information Technology Equipment safety requirement: 2011 has been implemented on December 1st, 2012. In addition, the GB8898-Audio Video and similar electronic apparatus safety requirement: 2011 has been implemented on November 1st, 2012. The current standards GB4943-2001 and GB8898-2001 will be invalid after the above deadline. Manufactures need to revise the current CCC reports and certificates to comply with the new standards before the deadline.
The main differences of the new version versus the current one are the requirements for higher altitude and tropical environment. Product intended for use at altitudes higher than 2000m or in tropical areas must meet the additional requirements for clearances and temperature rise. Critical components such as power supplies must have their certification reports revised to demonstrate compliance with the new requirements. There are other changes as well.
These include more stringent test requirements for ground impedance and touch current which may affect the construction of equipment under evaluation. For example the grounding test equipment must have a 32A minimum output current, which is higher than the IEC requirement of current 25A.
CHINA ENERGY LABEL: On November 23, 2012, AQSIQ and CNCA jointly announced a scope extension to the mandatory China Energy Label (CEL) scheme, to include personal computers for general use. The extension comprises desktop and portable computers, but not servers and/or workstations, industrial computers and personal computers with rated power above 750 W, and/or having two or more graphics processing units (GPU), or with display unit diagonal less than 11.6 inches.
The scope extension shall be effective from February 1, 2013. For products manufactured in or imported into China before the above date, there is a one year transition period until February 1st, 2014.
CHINA CCC AUTOMOTIVE COMPONENTS: It is expected that in 2013, the Chinese administrations AQSIQ and CNCA will publish an announcement regarding aluminum rims (alloy wheel) and child seats which will require mandatory CCC mark. Once the motion is passed and approved, the Chinese government will typically allow a six to twelve month transition period for manufacturers to obtain the CCC Mark.
CCC certification includes in-country product testing in a Chinese test lab and factory inspection, if applicable. Current vehicle components requiring mandatory CCC certification include seat belts, tires, safety glass, horns, reflectors, brake hoses, vehicle lights, rear-view mirrors, internal polymeric fitting materials, door locks, door hinges, fuel tanks and seat/head restraints.
EMC HELP: With higher data rates above 10 Gbps and operating frequencies above 1 GHz, the use of standard FR4 printed circuit board material is becoming marginal. Also, the operating voltages of today’s devices are getting lower and lower (less than 1.0 volt) which leads to increase crosstalk and immunity potentials. G&M can make you aware of all these issues and how to address them by proper selection of alternate board materials and good board design techniques. We can assist you by reviewing board layouts and design before you send it out for fabrication or by presenting a PCB or EMI seminar. Give us a call to see how G&M Compliance, Inc. can help you.