Tag: CB scheme

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

by on Aug.24, 2015, under Medical, Product Safety

EN-60601-monitorIn 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).

Transition Dates
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).

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IT Equipment Compliance to IEC 60950 for Taiwan BSMI Requires Additional I/O Port Testing

by on Nov.25, 2013, under China, Product Safety

For a manufacturer looking to add Taiwan to its information technology equipment homologations program, a BSMI approval is required.  Therefore, testing supplemental to typical IEC 60950 certification is necessary. 

Standard compliance with IEC 60950 allows for the waiver of testing of I/O ports if they are sourced from a SELV (safety extra low-voltage) and/or power limited circuit. Most data and communication ports, like USB, video, and Ethernet, are sourced from these type of circuits.  IEC 60950 says there is no need to prove via testing what is confirmed by engineering evaluation.

From BSMI’s perspective, they never know if and how the end user will misuse and connect improper devices to these ports, so they assume the worst case scenario and require all I/O ports be tested.  BSMI references standard CNS 14336 for this.

Another important note: The power supply will also require additional testing if it doesn’t already have BSMI certification.  The end product manufacturer should: 

  • Request the BSMI certificate from the power supply vendor/manufacturer
  • If this is not available, request the power supply vendor/manufacturer to submit an amended CB scheme report covering the additional testing

MET Labs is experienced in helping major IT equipment manufacturers with their international approvals and global homologations programs.  Contact us for a free quote, or submit a question to Pat, our electrical product compliance expert.

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MSHA Mine Product Approvals Speeded by Independent Test Labs

by on Jun.03, 2013, under Product Safety

Electrical products destined for hazardous work locations are required in the U.S. to be product safety certified to NRTL requirements.  However, for products destined for use in explosive gas and dust atmospheres of a U.S. underground mine, NRTL safety certification is not sufficient – Mine Safety and Health Administration (MSHA) approval is required.

Cue the long groan.  MSHA, like most U.S. government agencies, is understaffed and overworked, leading to long approval delays.

But there are options.  Under MSHA’s Subchapter B – Testing, Evaluation, and Approval of Mining Products, Part 6, the U.S. Department of Labor agency has created guidelines for the testing and evaluation of mine equipment by independent laboratories and non-MSHA product safety standards.

This program applies to these product categories:

  • Battery Powered Mobile Machines
  • Batteries for Mobile Machines
  • X/P Connection Boxes/Enclosures
  • X/P Plug and Receptacles/Connectors
  • Diesel Electronics
  • Electric Cap Lamps
  • X/P Electric Motors
  • Permissible Fans
  • Flashlights
  • Ground Check (Wire) Monitors
  • Intrinsically Safe Instruments
  • Intrinsically Safe Relays
  • Lighting Systems
  • Communication Systems
  • Multi-Gas Detectors – Handheld
  • Machine Methane Monitoring Systems
  • Telephone and Signaling Devices
  • Water Pumps

MSHA will accept testing and evaluation performed by an independent laboratory for purposes of MSHA product approval provided that they receive:

  1. Written evidence of the laboratory’s independence and current recognition by a laboratory accrediting organization
  2. Complete technical explanation of how the product complies with each requirement in the applicable MSHA product approval requirements
  3. Identification of components or features of the product that are critical to the safety of the product
  4. All documentation, including drawings and specifications, as submitted to the independent laboratory by the applicant

MSHA will accept equivalent non-MSHA product safety standards, assuming they provide the same degree of protection.  With modifications, these standards are accepted:

  • IEC 60079-0, Fourth Edition, 2004-01
  • IEC 60079-1, Fifth Edition, 2003-11

MET Labs is an independent and accredited test lab that offers testing and reporting as part of an MSHA approval application.  Test data is delivered to the manufacturer, which then submits the formal application to MSHA.  In our communication with the agency, applications submitted as part of this Part 6 program are looked at within about 2 months, as compared to up to over a year for standard MSHA approvals.

Contact MET for safety certification for hazardous location approvals for NRTL & MSHA in U.S., ATEX for EU, & IECEx for the international CB Scheme.

Need in-person training?  Attend a Hazardous Location Testing Seminar in Texas in July.

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FAQs Regarding IEC 62368-1, the Replacement for IEC 60950-1 & IEC 60065

by on Feb.25, 2013, under Product Safety

What is IEC 62368-1?
It is the new safety standard for Information Technology Equipment and Audio/Video Equipment.  It is intended to replace IEC 60950-1 and IEC 60065.  It is a hazard-based, performance-oriented standard.

Is IEC 62368-1 a risk-based standard?
No! Unlike IEC 60601-1, 3rd Edition, risk analysis is not required.  Neither is it a simple merger of IEC 60065 and 60950-1.

Why are IEC 60950-1 & 60065 being replaced?
Technology is changing, and IEC 62368-1 is technology independent.  It also minimizes the need for national/regional differences.

Is IEC 62368-1, Edition No. 1 being adopted internationally?
The United States (ANSI-UL 62368-1), Canada (CSA C22.2 No 62368-1), Denmark, Netherlands, & South Africa adopted national versions.  Edition No. 1 was not supported by Europe (CENELEC), which wanted further refinement of requirements before adoption.  In Asia, multiple countries are doing a close study of it.  For the IECEE CB Scheme, IEC 62368-1 has been activated under OFF/TRON.  OFF & TRON account for over half of CB Scheme certifications.

What is the status of IEC 62368-1, Edition No. 2?
Edition No. 2 of IEC 62368-1 (108/495A/CDV) was distributed in December and has a closing date for voting by TC108 National Committee Participating members of March 1, 2013.  The U.S. TAG TC108 will reportedly submit an affirmative vote on the CDV.  The IEC target publication date is the second half of 2013.  Then, it is expected that Europe will adopt EN 62368-1, 2nd edition, with a likely 5 year effective date.  The target publication date of Edition No. 2 of CSA/UL 62368-1 is summer 2014, with a likely 5 year effective date.

When will IEC 60065 & 60950-1 be transitioned out?
It is expected the last versions of IEC 60065 (8th edition) and IEC 60950-1 (2nd edition,
Am. 2) will be published in 2013.  In Europe, the final versions of EN 60065 and EN 60950-1 are expected to be published in 2013 with a likely 3 year effective date. For the U.S. & Canada, final versions of CSA/UL 60065 & 60950-1 are expected to be published in 2014, with a likely 3 year effective date. For the EU & North America, new certifications of A/V, IT & CT Equipment are likely to be required to comply with an IEC 62368-1 based standard beginning around 2018.

Have additional questions about the change?  Ask Pat, our compliance expert.

Need testing for IT or A/V equipment?  Request a quote.

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Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2012

by on Jan.15, 2013, under EMC, Product Safety

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IECEE Suspends Brazil NCBs and CBTLs from CB Scheme

by on May.14, 2012, under Product Safety

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.

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E3 Energy Program and IEC 62368-1 Discussed by IECEE U.S. Committee

by on Mar.08, 2012, under ENERGY STAR, Product Safety

MET Labs participated in a meeting this week of the United States National Committee of the IECEE to discuss a number of issues. 

E3 Program
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.

IEC 62368-1
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 EMC
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.

Motors
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.

See a list of participating CB Scheme countries, and get a quote for CB Scheme testing.

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Product Safety Compliance Engineers Use These Resources

by on Jan.19, 2012, under Product Safety

Over the years, we at MET Labs have compiled dozens of web links for keeping current with product safety regulations and industry happenings.  Following are some of the most valuable.

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.

Regulatory
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.

Miscellaneous
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.

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EU Association Accuses UL of Abusing Its Position in the U.S. Product Safety Certification Market

by on Dec.19, 2011, under Product Safety

In October, a European industry association published a strong-worded position paper that details how EU manufacturers suffer from the “malfunctioning of the U.S. certification market,” due to Underwriters Laboratories’ “abuse of its dominant position.”  The paper’s author, Orgalime, is the European Engineering Industries Association that represents some 130,000 companies in the mechanical, electrical, electronic, metalworking & metal articles industries of 22 European countries.

The complaint centers on the certification of components like control devices, circuit boards, cables, electrical connectors, power supplies, and switching devices.  Although component safety certification is not required under U.S. regulations as governed by Occupational Safety and Health Administration’s (OSHA) Nationally Recognized Testing Laboratories (NRTL) program, most component manufacturers do it anyway, to give confidence to end product manufacturers that are integrating the component.

There are 16 current NRTLs including MET Labs, according to the OSHA NRTL list.  All the NRTLs have the same legal standing and are viewed as technically equivalent, if their scopes of accreditation include the same U.S. national standard.  According to Orgalime, only one NRTL – UL – will categorically reject any component certification issued by another NRTL lab.  UL will issue a certificate for a complete product in which electrical components are embedded only if UL itself has certified the electrical components beforehand.

This is significant because UL controls more than 50 percent of the safety certification market, due to years of enjoying a virtual monopoly position.  The market was opened up in 1988 due to action initiated by MET Labs, but the legacy of market dominance continues.

According to Orgalime, this practice of denying recognition of component certificates delivered by other NRTLs causes a “de facto quasi-monopoly situation” from the component manufacturers’ viewpoint.  “This behaviour not only restricts the freedom of choice of manufacturers, but also proves to be expensive and causes delays in the development process of a machine.  Orgalime considers this situation as a classic case of market failure.”

Orgalime also points to UL’s anti-competitive behavior as a U.S. National Certification Body (NCB) within the International Electro-technical Commission’s (IEC) Certification Body (CB) Scheme.  Within this scheme, members agree to peer-review audits and mutual recognition of CB Certificates. In this case, UL is obliged to accept test results from all participating NCB’s, but the price which manufacturers have to pay for permission to use the UL logo based on testing results by another CB is higher than the entire testing procedure by UL itself including the contract for the use of the logo.

In a letter to European Trade Commissioners, Orgalime asks the European Commission to bring these concerns to the Transatlantic Economic Council to encourage U.S. authorities to correct the lack of obligatory recognition among the accredited NRTLs of component certificates.

Read more about product safety testing and certification.

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Energy Efficiency Testing for Products Becoming More Widespread

by on Nov.28, 2011, under ENERGY STAR

The fastest growing sector of the electrical and electronic product test business is energy efficiency testing. This is no surprise, what with the ongoing depletion of known supplies of fossil fuels and its associated geo-political and cost implications, combined with the pollution and attendant climate change associated with energy consumption.

Here is an overview of some of the top product energy efficiency programs in major markets:

United States
In the U.S., ENERGY STAR – a voluntary program – is king.  As covered here before, effective December 31, 2010, all ENERGY STAR products were required to be certified by an EPA-recognized certification body, like MET Laboratories.  Today, there are more than 60 ENERGY STAR product categories, with 6 more in development. 

In May 2011, U.S. EPA debuted the Most Efficient of ENERGY STAR pilot program.  Today, there are more than 150 models from 16 manufacturers recognized as Most Efficient.  MET Labs learned at the ENERGY STAR Partner Meeting in Charlotte earlier this month that EPA is extending the Most Efficient pilot through 2012 with limited changes. 

Canada
In Canada, Natural Resources Canada (NRCan) maintains the Energy Efficiency Regulations and Standards for Industry.  There are over 30 products regulated for energy efficiency in Canada.

Canada also participates in ENERGY STAR.

Europe
The EU utilizes three labeling schemes: Energy Labels, Ecolabels, and Ecodesign.

Energy labels are mandatory for all appliances placed on the EU market, and are specified in energy labelling Directive 2010/30/EU.  Energy labels display ranking of products according to their energy efficiency consumption on an A to G scale.  Once the majority of products reach class A, up to three classes (A+/A++/A+++) are added on top of class A.

Ecolabels are voluntary labels adopted by the European Commission on a product-by-product basis, and are specified in Ecolabel Regulation EC/66/2010. The Ecolabel, i.e. the flower logo, may be displayed if the product is among the most environmentally friendly in its sector.

Ecodesign requirements are applied on a product-by-product basis, and are specified in Ecodesign Directive EC/2009/125.  Ecodesign requirements are mandatory and must be met by all products placed on the EU market. They are based on an assessment of the impact of the product on the environment throughout its life-cycle, starting from the production stage, through to distribution and disposal.

Europe also participates in ENERGY STAR.

CB Scheme
During IECEE assessor training in Toronto earlier this month, two MET Labs CB Scheme assessors learned more details about IECEE’s new Energy Efficiency, Energy Performance and Energy Consumption Program (dubbed E3 Program). 

The IECEE Secretariat is now receiving applications from qualified labs for scope extension to operate in the IECEE E3 Program.

Certification within the E3 Program will provide a test report issued by a IECEE CBTL (Certification Body Testing Laboratory) and validated by a STR (Statement of Test Result) issued by an IECEE NCB (National Certification Body). The service can be used as a stand-alone service or as a combined safety and energy efficiency/performance service, upon request from the manufacturer, where both Test Reports are attached to the CB Test Certificate or the FCS (Full Certification Scheme) Certificate issued by the IECEE NCB.

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