Like 60601-1 before it, CENELEC and IEC 61010-1: 2010 – along with CSA and UL 61010-1 Third Edition, 2012 – are moving to Third Edition. 61010-1 is the internationally harmonized safety standard for laboratory, process control, and test & measurement equipment. Products sold into the EU must comply with the 3rd edition of EN 61010-1 by October 2013.
The scope of the standard is expanded to cover the following types of equipment:
- Electrical test and measurement equipment
- Electrical laboratory equipment
- Electrical industrial process-control equipment
Note: Hand-held probe assemblies are no longer covered by IEC 61010-1; a new standard IEC 61010-031 has been created.
As of October 1, 2013, compliance with EN 61010 3rd Edition will be mandatory for products needing to comply with the EU low voltage directive for CE marking. The CB Scheme accepted IEC 61010-1 in August 2010. In North America, UL announced the effective date for 61010-1 third edition is January 1, 2018. CSA has not yet announced an effective date for the third edition.
Laboratory equipment requiring certification to a particular standard EN 61010-2-XXX must demonstrate conformity within three years of that particular standard’s date of ratification.
Following is a summary of the most significant changes in EN 61010-1, 3rd Edition.
- Introduces the requirement for red pushbuttons and indictors
- New allowance for products with permanent supply cords
- New test for transformers with a protective bonding screen
- New requirements for layered PWBs, molded and potted parts, and thin-film insulation
- With Annex K, covers the new requirements for insulation, including air clearance and creepage distances
- Test voltages are no longer based on clearance distances, thus interpolation is no longer needed
- Voltage tests on solid insulation are now 1 minute, up from 5 seconds
- New standard for impulse test is now EN 61180-1 (formerly EN 60060), and requires 5 impulses instead of 3
- Requirements for sharp edges were added
- Introduces the new requirements for moving parts, which include risk assessment requirements
- New requirements for gaps between moving parts, and limiting forces and pressures
- New requirement for load testing on parts supporting heavy loads
- New requirement for support feet and castors
- Introduces risk assessment as a means of identifying the levels of energy the equipment must resist during mechanical stress testing
- Added the IK rating as a means to identify the degree of protection required for the enclosure, referencing EN 62262
- Surface temperature limits were modified to align with EN 563
- Leakage and rupture at high pressure is checked by inspection
- Fluids now defined as including both liquids and gases
- Spillage test now includes aggressive substances (as for IVD equipment in EN 61010-2-101)
- Radiation requirements have been modified to include intended and unintended emission
- New requirements for reasonably foreseeable misuse and ergonomic aspects
Clause 17 (New)
- Added to deal with hazards and environments not covered by the standard, along with the new Annex J dealing with risk assessment
- Requires a review of the manufacturer’s risk assessment file as part of the overall evaluation of the product
Contact MET to determine how these changes affect your products.
Or attend a free 61010-1 webinar in July that will cover the standard and its changes in more detail.
Early Consideration of EMC & Product Safety Compliance in Product Development Saves Time and Headaches
When developing a new electrical product, early consideration of electromagnetic compatibility (EMC) and product safety compliance issues will pay major dividends later.
If compliance is not engineered in from the start, expect to endure this pain:
- A major delay as the product is redesigned, jeopardizing time to market and product viability
- Significant extra costs for rework and increased product cost
- Team dissension and rock-bottom morale
What’s the best way to integrate compliance into a new product? First, get buy in from senior management, then:
- Buy and read the relevant safety and EMC standards and train your design engineers in the basics of compliance
- Have your compliance engineers work side by side with the designers, providing deeper expertise when needed, and information about the latest changes to standards and regulations
- Perform early design reviews and early testing on the first prototypes to lower the risk during final compliance testing
Don’t have a compliance engineering team? We can help. In addition to testing and certification, MET Labs offers compliance assistance, with controls in place to prevent a conflict of interest, as required by our accreditation agencies.
In recent years, software has been king in Silicon Valley. Now the pendulum is swinging back, and hardware is taking center stage again, says Bloomberg Businessweek.
The strongest evidence is the tablet war, which has been dominated by Apple’s iPad. Now, however, all the big players are piling in. Within two weeks of each other, Microsoft unveiled its new Surface tablet, and Google announced a partnership with Asustek Computer to build the Nexus 7.
Amazon has been making Kindles since 2007. Barnes & Noble has its Nook e-reader. Oracle purchased server maker Sun Microsystems in 2009 to house its databases.
Fueling the trend for small companies is Kickstarter and other crowd-funding sites. That’s how the iPhone-enabled gTar guitar got its start.
The high tech hardware boom extends beyond personal electronic devices. In the symbolic return of hardware and its manufacture stateside, MET Labs-tested all electric cars from Tesla Motors are produced in a Fremont factory not far from where an Apple manufacturing plant was shuttered in the early 1990s.
Tesla is not the only big name producing locally; Google is manufacturing its new Nexus Q entertainment device in the Bay Area.
We are encouraged by this return to prominence of hardware, not only for the increased business for 3rd party test labs like MET Labs, but also for the return of balance to the U.S. tech industry that will ensure its future health.
Have a question about electronic hardware regulatory compliance? Ask Pat, our compliance expert.
Or contact us to get a tour of one of our Bay Area labs.
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.
The U.S. Federal Communications Commission (FCC) has issued draft revisions to six Knowledge Database (KDB) publications for RF exposure and SAR compliance.
KDB Publication 447498 – General RF Exposure Policies for Equipment Authorization
KDB Publication 941225 – SAR Evaluation Considerations for LTE Devices
KDB Publication 865664 – SAR Measurement Requirements, Compliance Reporting and Documentation for 100 MHz – 6 GHz
KDB Publication 616217 – SAR Evaluation Considerations for Laptop, Notebook, Netbook and Tablet Computers
KDB Publication 648474 – SAR Evaluation Considerations for Handsets with Multiple Transmitters and Antennas
KDB Publication 643646 – RF Exposure Evaluation Considerations for Occupational Push-to-Talk Two-Way Radios
The public may post a comment on these proposed revisions through June 1, 2012.
Other RF Exposure KDBs
Remaining RF exposure KDB publications that do not have draft revisions are:
- KDB Publication 248227 – Additional SAR Measurement Procedures that Specifically Address 802.11 a/b/g Devices
- KDB Publication 615223 – SAR Requirements and Procedures for 802.16e/WiMax Devices
- KDB Publication 450824 – SAR Probe Calibration and System Verification Considerations for Measurements from 150 MHz to 3 GHz
- KDB Publication 680106 – Rules Regulating Short Distance Wireless Inductive Coupled Charging Pads or Charging Devices
Questions about SAR compliance? A SAR testing expert will be available next week at 2012 International CTIA Wireless at the MET Labs exhibit.
The recent delay in the high-profile new product launch of the Raspberry Pi has reminded electronics manufacturers of a simple truth: Compliance sometimes means exceeding regulatory requirements due to buyer demands.
The iPhone-size Pi is a $25 mini PC that is intended to teach students about programming. Its maker, the UK-based Raspberry Pi Foundation, had been operating under the assumption that this type of engineering sample product could be sold in the UK without a CE mark. After all, the rival ARM-based Beagleboard development kit is sold under the same terms without a CE mark, as are the majority of similar prototyping platforms.
The rub here is that the Pi has proved wildly popular, making its distributors nervous about lawsuits. Distribution partners element14/PremierFarnell and RS Components insisted that the device receive a CE mark to indicate compliance with electronic emissions guidelines. Their judgment was seconded by the UK Department for Business, Innovation and Skills (BIS), which said the Pi did in fact need to carry the CE marking.
Last week, to everyone’s relief, the Pi passed EMC testing without requiring any hardware modifications. The testing was conducted at Panasonic’s facility in South Wales.
The device passed radiated and conducted emissions and immunity tests in a variety of configurations, as well as electrostatic discharge (ESD) testing. In the lab for all of last week, the Pi is now also reportedly compliant with requirements for United States’ FCC, Australia’s C-Tick, and Canada’s Technical Acceptance Certificate.
Find out more about testing requirements and cost and lead time for CE Marking.
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.
When it comes to development of products with an integrated laser or photonic technology (including fiber optics), it pays to be aware of product safety regulatory and compliance requirements from an early stage.
Lasers and other photonics technologies create unique risks due to their highly concentrated light. Therefore, regulations exist at various levels:
- Local (U.S.) – Rare
- State (U.S.) – Typically defer to either federal code (21CFR1040) or OSHA/ANSI (Z136)
- National (U.S.) – Federal Code of Regulations (21CFR1040)
- International – EN60825 (EU) & IEC 60825
Proper risk engineering practices must be employed to ensure the highest product safety and lowest liability.
Ergonomics has a growing place in design for operations to ensure:
- Appropriate usability of product, and;
- Operation of product does not violate safety performance standards
Operator/operations feedback in design is more advanced than mere focus groups or limited customer studies.
Putting prototypical hardware in the hands of operators and operations personnel and managing the feedback that results from use is the most effective method by which to design.
Read more about safety for products employing laser devices and LEDs.
For more information, attend a Laser Product Safety Compliance webinar on January 24, 2012. This free webinar will cover the specific standards and regulations in effect as they apply to photonics, and touch on related applicability with respect to product design, risk, and management.
The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) announced Friday that it will continue to require third-party certification via the Nationally Recognized Testing Laboratory (NRTL) program for electrical products.
The European Union requested that OSHA explore the possibility of adopting its system, known as Supplier’s Declaration of Conformity (SDoC). Under the EU system, manufacturers declare that their products meet safety requirements before placing these products on the market, requiring EU governments to operate a post-market surveillance system to verify whether products are safety compliant.
In 2008, in response to the EU’s request for the U.S. to adopt an SDoC system, OSHA issued a request for information (RFI). After reviewing 63 RFI comments and independently studying the matter, OSHA declined to alter its existing system.
OSHA offered a few reasons for sticking with the NRTL product safety system:
- The SDoC system is no more protective of electrical product users, and may be less
- The cost of administering a SDoC system is likely not compatible with OSHA’s current budget
- The lack of explicit legislative authority to implement the enforcement powers required for an effective SDoC system, including issuing product recalls and bans, assessing fines, and imposing criminal penalties
Read more about the history of the NRTL program in MET Labs’ product safety FAQ.
The first university-level program focused primarily on product safety managers has graduated its first class. The Certificate in Product Safety Management was launched as a pilot project, and ran from June through early December.
Participants from manufacturing, retailing, and importing companies are the first holders of the certificate offered by Saint Louis University’s Center for Supply Chain Management Studies in cooperation with ADK Information Services, LLC. A second course will start January 24 in St. Louis.
The course included a series of workshops and online distance learning modules and webinars, covering all elements of a product safety system:
- Compliance and regulations
- Risk management
- Product safety design
- Hazard analysis
- Warnings and labels
- Standards, certification, and testing
- Supply chain
- Data management
- Product recall management and product retrieval
Participants also prepared presentations on case study topics involving product safety incidents and issues. See more course content detail.
For the spring semester, there will be revisions in how some topics are organized, new topics will be added, and future courses will feature expanded opportunities for presentations and team building. There will be greater focus on risk management at each point in the product safety system. More attention will be paid to the unique interests of participant industries: manufacturers, retailers, and importers/exporters. Special webinars addressing timely topics will be included, such as the new CPSC Searchable Public Database.