In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1. More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices.
For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles has been clarified, the amended standard includes new requirements regarding essential performance, mandates usability engineering evaluations, and requires the adoption of a formal development life cycle process for software. The amended standard also includes a number of new or revised technical specifications for electrical and mechanical hazards, as well as new product labeling and documentation requirements.
This Compliance Today blog post provides an overview of the new and modified requirements included in IEC 60601-1 Edition 3.1.
Risk Management (Subclause 4.2)
The description of risk management has been rewritten to clarify how ISO 14971:2007 should be applied. The rewrite clarifies that a full ISO 14971 assessment and post-production monitoring are not required for compliance.
Essential Performance (Subclause 4.3)
Amendment 1 now requires manufacturers to establish specific performance limits, and to evaluate essential performance characteristics under abnormal or fault conditions. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Also, manufacturers must declare specific essential performance criteria in the product’s technical description.
Humidity (Subclause 5.7)
Humidity testing requirements from IEC 60601-1 Edition 2.0 have been reinstated.
Documentation (Clause 7)
A number of new documentation requirements for user manuals and instructions for use (IFU) have been added. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC 60601-1-6, Usability, in determining what information must be presented.
Marking and Labeling (Subclause 7.2.2)
Equipment and accessory labeling must include a unique serial number or lot batch identifier, date of manufacturer or “use-by” date, and manufacturer contact information.
Electrical Hazards (Clause 8)
There are a number of changes related to protections from potential electrical hazards, including defibrillation protection, protective earth and creepage and clearance distances. There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets. Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user.
Mechanical Hazards (Clause 9)
Testing for mechanical hazards related to instability and mobile equipment has been modified to include functional testing.
Temperature Testing (Clause 11)
For applied parts, temperature limits have been clarified. For overflow, equipment must be designed to ensure that basic safety and essential performance are maintained at all times.
Programmable Electrical Medical Systems (PEMS) (Clause 14)
Amendment 1 incorporates many of the specific requirements of IEC 62304:2006, Medical Device Software Life Cycle Processes, which are applicable to equipment and systems whose operation depends on software or any programmable element (also known as PEMS). In addition, Amendment 1 incorporates validation requirements for equipment connected to a network.
Construction (Clause 15)
For mechanical strength, “basic safety and essential performance” replaces “unacceptable risk.” Requirements for the construction of transformers have reverted to IEC 60601-1 Edition 2.0. Lithium batteries must comply with IEC 60086-4 (primary cells) and IEC 62133 (secondary cells).
The U.S. FDA has set a transition date of August 2016 for compliance with Edition 3.1. For the NRTL program, the U.S. Occupational Safety and Health Administration (OSHA) has adopted ANSI/AAMI ES60601-1: 2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. Both of these national standards are deemed the equivalent of IEC 60601-1 Edition 3.1, but they may also include national deviations that trigger additional requirements for regulatory approval. Thus, there is some uncertainty around transition dates.
In the European Union (EU), EN 60601-1:2006/A1:2013 (the EU’s equivalent of IEC 60601-1 Edition 3.1) has been published in the Official Journal (OJ) as a harmonized standard under the EU’s Medical Device Directive (93/42/EEC). So, as of Dec. 31, 2017, compliance with the provisions of EN 60601-1: 2006 (equivalent to IEC 60601-1 Edition 3.0) will no longer be accepted as evidence of conformity with the essential requirements of the Directive.
Adding another level of complexity, transition dates for equipment and systems subject to the requirements of a collateral and/or particular standard in the IEC 60601 series (designated IEC 60601-1-xx and IEC 60601-2-xx) may differ from those applicable to other types of devices.
For device manufacturers that use the IECEE’s CB Scheme, a further challenge is the requirements presented in the IECEE’s Operational Document OD-2055. Published in 2014, OD-2055 requires manufacturers seeking certification to IEC 60601-1 as amended to also comply with the usability engineering process that is detailed in IEC 62366-1:2015.
MET Labs is a leading agency for 3rd party testing and certification of medical electrical equipment to the latest edition of IEC 60601-1 for all major markets. Contact us for questions about Edition 3.1 or for a free quotation to test your device(s).
External Power Supplies Must Meet Level VI Energy Efficiency Requirements for U.S. DoE by February 2016
The global regulatory environment for external power supply energy efficiency has rapidly evolved over the past decade since the California Energy Commission (CEC) implemented the first mandatory standard in 2004. Now, external power supplies sold in the U.S. must meet updated and expanded U.S. Department of Energy (DoE) Level VI Energy Efficiency requirements by February 10, 2016.
The new DoE standard mandates more stringent energy efficiency levels for a greater number of external power supply types. The DoE estimates that these requirements will save consumers up to $3.8 billion and cut emissions by nearly 47 million metric tons of carbon dioxide over 30 years, equivalent to the annual electricity use of 6.5 million homes.
In the early 1990s, it was estimated that there were more than one billion external power supplies active in the U.S. alone. The efficiency of these power supplies could be as low as 50% and still draw power when the application was turned off or unconnected (a “no-load” condition). Experts calculated that without efforts to increase efficiencies and reduce no-load power consumption, external power supplies would account for around 30% of total energy consumption in less than 20 years.
While many countries still have voluntary programs harmonized to the international efficiency marking protocol system first established by the ENERGY STAR Program, the U.S., Canada, and European Union now have mandatory energy efficiency regulations in place for external power supplies.
Today, Level V will meet or exceed the requirements of any governing body around the globe. Power supply manufacturers indicate compliance by placing a Roman Numeral V on the power supply label as specified by the International Efficiency Marking Protocol for External Power Supplies Version 3.0, updated in September 2013.
The internationally approved test method for determining efficiency has been published by the IEC as AS/NZS 4665 Part 1 and Part 2. The approach taken to establish an efficiency level is to measure the input and output power at 4 defined points: 25%, 50%, 75% and 100% of rated power output. Data for all 4 points are separately reported as well as an arithmetic average active efficiency across all 4 points.
Power supply manufactures are already preparing for the coming transition in February 2016 to the more stringent Level VI standards. Along with tightened regulations for existing adapters, the new standard expands the range of products that fall under the standard to now include:
- Multiple-voltage external power supplies
- Products with power levels >250 watts
Direct Vs Indirect Operation
The new standard also defines power supplies as direct or indirect operation products. A direct operation product functions without the assistance of a battery. An indirect operation supply is not a battery charger but cannot operate the end product without the assistance of a battery. The new standard only applies to direct operation external power supplies. Indirect operation models will still be governed by the limits as defined by EISA2007.
The Level VI mandate also includes these exemptions:
- A device that requires Federal Food and Drug Administration AS/NZS 4665 listing and approval as a medical device in accordance with section 360c of title 21
- A direct operation, AC-DC supply with output voltage less than 3 volts and output current ≥1,000 milliamps that charges the battery of a product that is fully or primarily motor-operated.
The DoE Level VI requirement date is February 10, 2016, but it is important to note that compliance with the new standard will be regulated from the date of manufacture, so legacy products can still be shipped as long as the manufacture date is prior to the transition date. Labeling requirements will be required to meet the same International Efficiency Marking Protocol for External Power Supplies Version 3.0 as the current Level V standard.
Globally, it is expected that other nations will soon follow suit with this standard. In the EU, the mandatory European Ecodesign Directive for external power supplies is currently undergoing revision discussions and it is expected to harmonize with most, if not all, of the U.S. standards. Countries with existing efficiency regulations in line with the U.S., including Canada and Australia, are expected to harmonize with the new standard as well.
In addition to testing for the Department of Energy, MET is your one-stop-shop for energy efficiency testing and certification for ENERGY STAR, EU Ecodesign Directive, Natural Resources Canada, and the California Energy Commission.
As a leading 3rd party EMC Test Lab, MET Labs maintains a strict ISO/IEC 17025-2005 Quality System. This system includes a set of requirements addressing the subject of traceability of measurement results.
Traceability means that the result of a measurement can be related to a national or international measurement standard, and that this relationship is documented. In addition, the measuring instrument must be calibrated by a measurement standard that is itself traceable.
Traceability is important because it allows the comparison of the accuracy of measurements worldwide according to a standardized procedure for estimating measurement uncertainty.
To guarantee traceability, MET uses measuring equipment that has been calibrated by an accredited calibration laboratory and meets international specifications:
- CISPR 16-1-1 for a measuring receiver (EMI receiver or spectrum analyzer)
- ANSI C63.5 for antennas
If no standard is available to calibrate a piece of test equipment (e.g. for spectrum analyzers or signal generators), MET uses the equipment manufacturer’s calibration process, per ISO/IEC 17025.
Since the calibration of measuring receivers has caused confusion in the EMC community, CISPR subcommittee A is in preparation of a normative annex to CISPR 16-1-1 (the future CISPR 16-1-6) to better outline the calibration requirements for measuring receivers.
In summary, EMC test results at MET Labs are subject to a strict Quality System that ensures accuracy, repeatability, and traceability. Contact us today for a free quote for your next EMC testing need.
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