Calibration and test labs both stand to save time and money when calibrating/verifying chambers, due to an update to CISPR 16-1-4.
CISPR 16-1-4 Amd.1 Ed. 3.1 (2012) has replaced Ed. 2.0 (2007) for radio disturbance and immunity measuring apparatus – antennas and test sites for radiated disturbance measurements. The publish date was July 11, 2012.
The major addition that this amendment introduces is an alternative site validation method to Normalized Site Attenuation (NSA) called Reference Site Method (RSM). Here is how it works:
- Perform a site validation using a pair of transmitting/receiving broadband antennas (biconical and log periodic to cover 30MHz-1GHz) at a reference test site – this site represents an ideal test location
- Using the same pair of antennas, perform a site validation at the chamber that is being verified
- Compare the site validation readings between the two locations, with deviation not to exceed +/- 4dB
Since the same antennas have consistency between validations, antenna factors and uncertainties do not need to be taken into account. This is in contrast to the NSA method where the validation measurement of the site is being compared to a setup that does not use the same antenna pairs, so those additional factors need to be accounted for to equate the two different setups.
Otherwise, there were only minor definition updates and edits in this edition.
Background: CISPR is an international special committee on radio interference within the International Electrotechnical Commission (IEC). CISPR prepares standards that offer protection of radio reception from interference sources such as the electricity supply system, industrial, scientific and electro-medical RF, broadcasting receivers, and IT equipment (ITE).
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.
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.
As the weeks and months march on, IEC 62368-1 elicits more chatter. Designed to replace IEC 60950-1 2nd edition (IT equipment) and IEC 60065 7th edition (A/V equipment), the new product safety standard is not a merging of these two standards.
As new devices and applications emerge at an unprecedented rate, and technologies continue to converge, 60950-1 and 60065 have had to undergo numerous modifications, making them more complex and difficult to use. IEC 62368-1 is designed for long-term stability and relevancy, regardless of product advancements.
Nearly ten years in development, 62368-1 covers a broad range of products, and allows for the minimalizing of national or regional differences. Technology-neutral and performance – not prescriptive – based, the new standard is expected to help engineers integrate safety compliance early in the product design cycle and help manufacturers speed time to market.
IEC 62368-1 Ed 1.0: Audio/Video, Information and Communication Technology Equipment — Safety Requirements is based on the principles of Hazard-Based Safety Engineering (HBSE). Like the major risk-based change with IEC 60601-1 for electro-medical equipment, HBSE represents a paradigm shift for audio-visual, communication, and information technology products.
HBSE is a process that utilizes a three-block model to address the transfer of hazardous energy to a body part. It describes methods to mitigate hazards and measure safeguard effectiveness.
IEC 62368-1 also has some new requirements to enhance product safety, including:
- Methods for classifying energy sources
- Definitions for ordinary persons, instructed persons, and skilled persons
- Child accessibility test probe
Edition 1.0 of IEC 62368-1 was published as an international standard on January 10, 2010, with a minimum five year effective date recommended by IEC Technical Committee (TC) 108. The second edition is planned to be published in 2013. Final implementation of IEC 62368-1 second edition is likely sometime between 2015 and 2018. There will be a transition period where 60950-x, 60065, and 62368 will all need to be maintained.
See other product safety-related blog posts.
MET Labs’ James Bojorquez was in attendance and took these notes:
Much of the presentation recounted the history of how IEEE 1613-2003 “Standard Environmental and Testing Requirements for Communication Networking Devices in Electric Power Substations” was developed in 11 months.
This standard was developed with Class 1 & Class 2 specifications:
- Class 1 devices are allowed to experience data errors, loss or delays when exposed to EMI stress
- Class 2 devices must provide error-free operation when exposed to EMI stress
Neither class may experience any permanent damage under EMI stress.
Next is a Project Authorization Request (PAR) to extend the scope of IEEE 1613 to “In Electric Power Facilities” and add a communication profile for communications via RF to be underway during each of the four transient tests.
Tengdin was one of the U.S. members of IEC TC57 WG 10-11-12 that developed IEC 61850 “Communication Networks and Systems in Substations”. According to a new industry report from GlobalData, the global market for IEC 61850 compliant routers and switches is at an introductory stage, with growth concentrated in specific regions.
On a side note, MET Laboratories has experience testing to the three major requirements of IEC 61850-3: EMI, wide temperature, and shock and vibration resistance.
To learn more about EMI avoidance, register for one of these upcoming events:
Product safety certification for healthcare & other laboratory equipment continues to evolve. Thirteen months ago, on January 1, 2010, all new products and alternate constructions of listed or recognized products were required to be evaluated to UL 61010-1 2nd Edition.
The Second Edition combines UL 61010A-1 for laboratory equipment, UL 61010B-1 for test and measurement equipment and UL 61010C-1 for process control equipment into a single standard.
On January 1, 2014, UL 61010A-1, UL 61010B-1 & UL 61010C-1 will be withdrawn, and all listed and recognized products must comply with UL 61010-1 2nd Edition.
Europe is on a different schedule. October 1, 2013 is the EU date of cessation for IEC 61010-1 2nd Edition. (IEC 61010-1 2nd Edition is aligned with UL 61010-1 2nd Edition, except for some U.S. national differences in the UL edition.)
IEC published the Third Edition of 61010-1 in June 2010. See the abstract here. Some of the major changes to the new edition include:
- Scope now covers both professional and non-professional products
- Test and measurement circuit requirements separated into a Part 2 standard: IEC 61010-2-30
- Reworked Clause 6.7 and added Annex K for clearances, creepages, solid and thin film insulation and molded and potted parts
- Temperature requirements modified due to EN563
- X-ray requirements modified to include intended and non-intended emissions
- New requirements for conformal coatings
- New requirements for risk assessment
- Added requirements for foreseeable misuse and ergonomics
The United States Technical Advisory Group (US TAG) and harmonization committee is working on the North American harmonized standards to IEC 61010-1 3rd Edition. They are completing the National Differences and plan to have the standard developed and issued by the Spring of 2012.
Rick Cooper, MET Laboratories’ Product Safety Lab Director, is giving a presentation at Nemko AS this week on the differences between household product certification in North America versus Europe (IEC 60335-1). For those who can’t make it to Oslo, Norway, here is an abridged outline of the presentation.
Canada is more harmonized with the IEC 60335 series than the U.S. or Mexico.
United States has a lack of harmonization internationally, including with Canada. The U.S. has 34 legacy standards and 3 IEC-style standards.
Mexico participates in IECEE CB Scheme for HOUS. National differences apply and are contained in NMX-J-521-1.
- Proposed tri-national standard UL/CSA/ANCE 60335-1, First Edition
- Increased harmonization between the US, Canada, Mexico and IEC 60335-1
- No effective date published yet, but assumed to be in 2011
- Harmonization should prove to ease the acceptance of household products worldwide through the CB scheme