Tag: product safety
Audio/video equipment and information technology equipment intended for sale in China must meet new China Compulsory Certification (CCC) product safety requirements starting in November and December, respectively.
In February, the Certification and Accreditation Administration of China (CNCA) Technical Committee for High Tech Industry finalized the certificate update instructions for both GB8898 (Audio, Video and Similar Electronic Apparatus – Safety Requirements) and GB4943 (Safety of Information Technology Equipment). The updated standards are GB8898-2011 and GB4943.1-2011. The official change announcement was made April 10.
GB8898-2011 for A/V Equipment
After November 1, 2012, the China Quality Certification Centre (CQC) will only accept A/V equipment applications for the CCC Mark to the new GB8898-2011 standard. From November 1, 2012 onwards, non-compliant products will not be permitted to be imported into or sold in the China market.
For A/V products marketed under existing certificates, manufacturers are required to update their certificates according to the new standard by November 1, 2013, with an additional grace period extending to February 1, 2014. All suspended certificates will be withdrawn by the CQC after February 1, 2014.
GB4943.1-2011 for IT Equipment
After December 1, 2012, the CQC will only accept IT equipment applications for the CCC Mark to the new GB4943.1-2011 standard. From December 1, 2012 onwards, non-compliant products will not be permitted to be imported into or sold in the China market.
For IT products marketed under existing certificates, manufacturers are required to update their certificates according to the new standard by December 1, 2013, with an additional grace period extending to March 1, 2014. All suspended certificates will be withdrawn by the CQC after March 1, 2014.
For more information about these changes, contact MET China.
To learn about accessing many countries with a single certification, register for our CB Scheme Webinar.
Effective last month, Brazilian National Certification Bodies (NCBs) and CB Testing Laboratories (CBTLs) have been suspended from the IECEE CB Scheme. This is the first time that the IECEE has suspended a member.
The suspension is attributed to additional accreditation requirements of Brazil’s regulatory authority, the National Institute of Metrology, Quality and Technology (INMETRO). INMETRO requires that CB test reports and certificates come from a testing laboratory accredited by INMETRO or an Accreditation Body that is a signatory of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement (ILAC MRA). This requirement is not in line with the requirements of the IECEE, which is based on a Peer Assessment System between members of the IECEE CB Scheme.
The suspension prevents IECEE members from accepting test certificates and test reports from Brazil.
The IECEE CB Scheme is an international cooperation between 65 NCBs with hundreds of testing laboratories located in 50 participating countries. It is based on the principal of mutual recognition of test results for obtaining national safety certification of electrical equipment and components.
According to the IECEE Executive Secretary, Pierre de Ruvo, the suspension will be cancelled and full membership reinstated as soon as an agreement is reached with INMETRO and/or the Brazilian Committee of Electricity, Electronics, Lighting and Telecommunication (COBEI).
Laboratories – Learn how to become a CBTL of a U.S.-based NCB.
Manufacturers – Get a CB Scheme test report or test certificate.
Register for a free webinar: Using the CB Scheme to Access the World Marketplace.
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.
New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.
To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards. It states:
- If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.
These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.
Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.
The Health Canada website should be consulted for the most current List of Recognized Standards.
For the 3rd edition implementation schedule for the United States, see this Compliance Today post.
Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.
Following are recent and near future changes to electrical product regulatory requirements in South Korea.
Effective January 1, 2012, the Korean Communications Commission (KCC) requires radiated emission measurements at the limit, above 1GHz, by the highest internal source of the device and also conducted disturbance testing for devices with telecommunication ports. The limit is the same as CISPR 22:2006.
Effective July 1, 2012, the Ministry of Knowledge Economy (MKE) will assume responsibility for regulating safety of electrical products sold in Korea, a role currently carried out by KCC. After July 1, KCC will only regulate IT/RF/Telecom products.
Effective January 1, 2013, KCC plans to expand its existing SAR requirements for mobile phones to include all radio equipment that is used within 20 cm of the human body. This harmonizes the Korean SAR requirements with FCC and other international standard requirements. Low powered radio devices (below 20mW) are exempt from this new requirement.
Learn how to gain certification for the Korean market using a Conformity Assessment Body (CAB) under Phase I of the Asia Pacific Economic Cooperation Mutual Recognition Agreement for Conformity Assessment of Telecommunications Equipment (APEC Tel MRA).
Participate in a free International EMC Homologation webinar on April 10, 2012.
RCM Labeling of Electrical Products in Australia & New Zealand to Coincide with New EESS Safety Requirement
As detailed in Compliance Today before, the Australia C-Tick and A-Tick regulatory compliance markings will be phased out, replaced by the existing Regulatory Compliance Mark (RCM).
The RCM mark will be the only mark to indicate compliance with the Australian Communications and Media Authority’s (ACMA) regulatory arrangements for telecommunications, radio, EMC and electromagnetic energy (EME).
The new arrangement will commence July 1, 2012, in concert with the implementation of the new Electrical Equipment Safety System (EESS). Many regulatory observers believe the start date may slip to later in the year.
All new devices that are physically labeled for the first time from July 1, 2012 will need to be labeled with the RCM. The use of the C-Tick and A-Tick marks on all legacy products will be phased out by June 30, 2015. Devices that have already been labeled with the C-Tick or A-Tick mark but not sold (e.g. stock products) prior to the end of the transition period may continue to be offered for sale beyond that date.
The EESS is not a national requirement; it was created by state and territory electrical equipment safety legislation, and is not yet adopted across all of Australia and New Zealand.
The EESS marks a fundamental change to the electrical safety landscape for products sold in Australia and New Zealand. In-scope electrical equipment suppliers will be required to register their details on a national database and must make a declaration that all the equipment they sell meets relevant standards and is electrically safe. Evidence of compliance is required and is graded, based on risk.
Risk-based classifications of equipment are:
- Level 1 = low risk
- Level 2 = medium risk
- Level 3 = high risk
Level 2 and level 3 equipment are defined in AS/NZS 4417.2. All other types of in-scope electrical equipment are level 1.
In-scope is defined as all new electrical and electronic equipment that is designed or marketed as suitable for household or personal use whose voltage is greater than 50 V AC RMS or 120V ripple-free DC, and less than 1000V AC RMS or 1500V ripple-free DC.
For more information, see ACMA’s extensive FAQ on the changes (.docx).
Get educated on how to gain access to multiple markets – including Australia and New Zealand – by joining a free International EMC Homologation webinar on April 10, 2012.
There was much discussion about the E3 Program (Energy Efficiency, Energy Performance & Energy Consumption), covered in Compliance Today previously.
The U.S. initially opposed the E3 Program because there is a lack of harmonization. As it stands, there is no assured reciprocity and there is no certificate issued, just a Statement of Test Results (STR). It is up to the reader of the STR to decide to accept or not.
UL and CSA have recently published harmonized versions of IEC 62368-1. It will, however, likely be a long time before this becomes a NRTL standard due to OSHA’s workload and their likely objection to its inclusion of hazard-based analysis. Major labs will list to it, but if a product is going into the workplace, then 60950 or 60065 must still be used.
Only the U.S., Sweden and Denmark have adopted 62368-1 in the Scheme per the CB website. Canada is to participate soon, as is France. The Netherlands may participate soon.
More about IEC 62368-1 is found in this Compliance Today post.
China is not currently accepting EMC within the Scheme. China’s objection may be that this was once voluntary and that the Scheme adopted EMC as mandatory and have not given China time to revise its standards.
At least one manufacturer thinks there is a need for motors to be in the safety CB Scheme. The only place a motor standard is covered is within the EMC Scheme. NEMA’s 1MG Section is continuing its conversation regarding the inclusion of electric motors as part of the E3 Program.
Next meetings are May 22-23, 2012 in Vancouver, Canada, and August 7-8, 2012 in Orange County, California.
Yesterday was the last full day of the 2012 ICPHSO Annual Meeting and Training Symposium.
- CPSC is being proactive at ports. In 2010 & 2011, 6.5M units of over 2,000 products were seized.
- Independent 3rd party testing is set up and running well.
- A strong CPSC is good for business – it provides a more level playing field.
- Standards development, recalls process, and federal rulemaking will be priorities in 2012.
- Successful Saferproducts.gov public database will have one year anniversary on March 11. It has had 6,300 unsafe product reports.
Penalties and Enforcement
Also featured was a panel on Penalties and Enforcement, featuring Cheryl Falvey, U.S. CPSC General Counsel. Some of the points made there:
In August 2009, the maximum penalty went from $1.8M to $15M.
If the duty to report occurred in 2008 but was not reported until 2010, the violation occurred in the higher penalty period.
A failure to report and the deliberate subsequent sale of recalled product doubles the maximum penalty to $30M.
There has been less self-reporting and more anticipated litigation since the penalty increase.
There is no formula to calculating a penalty. Statutory factors include:
- Extent and gravity of the violation
Other factors include:
- Safety/compliance program
- History of noncompliance
- Economic gain for noncompliance
- Failure to respond timely to staff requests
Every settlement is subject to approval by CPSC commissioners. Then it is listed in the Federal Register for public comment.
The CPSC is looking for a case that makes a statement. “This has a deterrent effect,” says Falvey.
Individuals are now being pursued for felony criminal penalties. This often happens with Subchapter S corporations, where the individual is virtually the same as the corporation.
The CPSC can be creative. E&B Giftware was given a $550,000 civil penalty, with all but $50,000 suspended if they met requirements of the settlement.
The whistleblower provision in the Consumer Product Safety Improvement Act (CPSIA) of 2008 has only been used once. Calls are more likely to be a trade complaint from a competitor.
The 2012 International Consumer Product Health and Safety Organization (ICPHSO) Annual Meeting and Training Symposium in Orlando moved into Workshop Day yesterday.
Some of the topics that were addressed:
- Global regulatory outlook
- Comparing Canadian and U.S. Consumer Product Safety Law
- EU Directives related to toys
- Effective recalls
- Risk management
- Global product safety strategies
- Hazardous substance regulations
The most interesting workshop looked at what product safety agencies will be focused on in 2012.
The U.S. market was covered by Kenneth Hinson, Executive Director of the U.S. Consumer Product Safety Commission. Following are staff-proposed 2012 priorities, although he emphasized that they have not yet been approved by the Commission.
Import surveillance. Expand Risk Assessment Methodology (RAM) pilot.
Global outreach to regulated community. Build capacity of regulators in producer nations. Lead standards harmonization efforts. Continue operations of Beijing office.
Market surveillance and enforcement.
IT modernization to bridge silos. CPSRMS (Consumer Product Safety Risk Management System) and ITDS RAM.
Key mandatory standards activities. Table saws, portable generators, durable nursery products, etc.
Connecting with consumers. NSN and CPCS 2.0 Social Media Initiative.
Work on potential testing and certification revisions. Opportunity to reduce 3rd party testing burden (P.L. 112-28). Small batch manufacturing exemption. ATV final rule.
A side note. The next ICPHSO meeting will be in Brussels, Belgium October 16-17, 2012. In 2013, there will be meetings in Arlington, Virginia and on the Gold Coast of Australia. Spain will host a 2014 meeting, followed by plans to return to Japan and China. ICPHSO organizers were encouraged by a successful Asia-Pacific Consumer Product Safety Symposium in Seoul, Korea in 2011.
Yesterday was the first day of ICPHSO’s 2012 Annual Meeting and Training Symposium in Orlando, Florida. As a product safety certification body, MET Labs is participating.
The first day was “Manufacturers Day.” For electronics manufacturers, the most relevant presentations focused on new supply chain disclosure requirements, and factors in standards development.
Here are the key points from the supply chain disclosure panel:
With its REACH and RoHS requirements, Europe has the most stringent requirements in this area.
The U.S. is following, with California leading the way. Four states have ‘green chemistry’ laws: California, Washington, Wisconsin and Maine. An additional nine states had green chemistry laws introduced in 2011/2012: Maryland, Florida, Illinois, Michigan, New York, Massachusetts, Vermont, Oregon and Alaska.
As covered in Compliance Today previously, Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act will soon implement reporting requirements for four conflict minerals. This regulation will go into effect when the SEC hammers out the details, sometime before June 2012.
Manufacturers are struggling to do this tracking, although the limited number of global smelters helps. Peggy Fowler, Walmart’s Senior Director of Corporate Product Safety and Regulatory Compliance, says companies should demonstrate due diligence steps, even if not all information is known.
Here are key points from a presentation on standard development:
A risk assessment looks at the frequency of an injury and its severity. Also, who is at risk? The EU RAPEX approach is a good model.
Don Talka, UL VP, gives an example of hair dryers:
- Frequency of injury: low
- Severity of injury: high (death)
- At risk: children
- Injury probability: high if device falls into bath tub
- Perceived cost of implementing fix: high – sometimes doubling cost of product
- Resolution: multiple steps were taken to safely allow full immersion
Have a thorough understanding of issue:
- Accept there is a problem
- Do a root cause analysis based on HBSE principles
- Discuss in a balanced group (STP or task group)
Stay tuned – Up soon is a corresponding post on EMC compliance resources.
Standards & Schemes
CB Scheme The international certification program managed by the IECEE, with over 60 countries participating.
IEC The International Electrotechnical Commission publishes consensus-based International Standards and manages conformity assessment systems for electric and electronic products.
CENELEC The European Committee for Electrotechnical Standardization. It creates voluntary European electrotechnical standards (ENs).
UL Catalog of Standards UL has developed more than 1,000 standards for safety.
CSA Standards Canadian Standards Association Online Store.
BSI Standards The UK’s National Standards Body (NSB) and was the world’s first.
Standards Australia Australia non-government standards body.
Standards New Zealand New Zealand’s leading developer and publisher of standards.
ANSI American National Standards Institute is the voice of the U.S. standards and conformity assessment system.
IHS Standards Has a wide variety of standards available for purchase.
NFPA Codes & Standards National Fire Protection Association has developed more than 300 consensus codes and standards to minimize the possibility and effects of fire and other risks. Publishes NEC.
U.S. OSHA NRTL Program OSHA is responsible for managing the Nationally Recognized Testing Laboratory Program for U.S. product safety certification.
U.S. CPSC U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death from thousands of types of consumer products.
U.S. MSHA Mine Safety and Health Administration works to prevent death, disease, and injury from mining in the U.S.
U.S. Laser Safety Regulations The U.S. Code of Federal Regulations outlines U.S. laser safety requirements.
Standards Council of Canada The SCC is responsible for accrediting certification bodies for the Canadian market.
EU Directives Includes links to harmonized standards references.
RAPEX The EU rapid alert system for dangerous consumer products, with the exception of food, pharmaceutical and medical devices.
CNCA Regulations of the People’s Republic of China on Certification and Accreditation and Applying China Compulsory Certification (CCC) Mark
RRA National Radio Research Agency, Korea’s regulatory agency for KC Mark.
BSMI Bureau of Standards, Metrology & Inspection is the authority responsible for standardization, metrology and product inspection in Taiwan.
GOST Russia Federal Agency on Technical Regulating and Metrology.
Publishers: Magazines & Blogs
IAEI Magazine Magazine for electrical inspectors.
IN Compliance Magazine Formerly Conformity, covers product safety along with other compliance disciplines.
Product Safety Letter Digital newsletter and website.
Test & Measurement World Covers product safety occasionally.
Hazardous Area International Magazine Coverage includes hazardous location and explosive atmosphere compliance.
Compliance Today Blog The latest news and resources to help electrical product manufacturers comply with regulatory and buyer requirements, from MET Laboratories.
Certification & Test Blog Information, from TRaC Global, on testing and certification services, ranging from telecoms & radio and environmental, through to analysis, safety and EMC.
Directive Decoder Blog Analysis of European legislation.
NEMA Currents Blog Blog of the Association of Electrical and Medical Imaging Equipment Manufacturers.
IEEE The Institute of Electrical and Electronics Engineers is the world’s largest professional association dedicated to advancing technological innovation.
PSES Email Forum A lively Listserv made up of about 700 engineers and technicians. Sponsored by IEEE.
Testing Equipment Suppliers Published by IECEE.
ICPHSO The International Consumer Product Health and Safety Organization.
What are your favorite online product safety compliance resources? Please leave a comment with a link to it.