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.

This is no accident. The NEBS (Network Equipment Building System) family of standards is designed to keep the network running no matter what, and they are more comprehensive and more difficult to comply with than any other test suite we run at MET Labs. 

In NEBS testing, the Telcordia Generic Requirements (GRs) is what members of the Telecommunication Carrier Group (TCG), such as Verizon and AT&T, use to evaluate telecommunications equipment for safety, reliability and performance, as well as its impact on the environment of telecom facilities.  Some non-TCGs, like Comcast, also require a subset of NEBS testing.

Despite the initial cost of compliance, meeting NEBS requirements can positively impact a manufacturer’s bottom line in a significant way.  Increasingly, telecommunications equipment manufacturers around the world are requiring their component suppliers – wire line and wireless – to demonstrate compliance with NEBS and including this stipulation in requests for proposal (RFPs) and supplier contracts.

Equipment manufacturers document compliance to NEBS requirements by having testing or witnessing performed by an ISO 17025 accredited independent test laboratory (ITL), like MET Laboratories. 

NEBS requirements apply to telecommunications equipment installed in a Central Office (CO) environment, certain Outside Plant applications (OSP), and Customer Premises Equipment (CPE). There are generally two primary GRs that apply to most equipment designated for use in a CO: GR-1089-CORE Issue 6, which covers electromagnetic compatibility, electrical transients and electrical safety; and GR-63-CORE Issue 4, which covers physical requirements that include high/low temperatures, high humidity, shock and exposure, fire ignition and flame spread, seismic conditions and airborne contaminates.  Individual TCGs may have additional requirements.

NEBS requirements are divided into three levels of compliance:

• Level 1 comprises only safety and risk criteria. Conformance to Level 1 does not assure equipment operability or service continuity. Level 1 is typically used by service providers for early deployment into their COs and/or interoperability laboratories, and to allow collocaters to install equipment in a central office.
• Level 2 includes all requirements of Level 1 with some added level of operability reliability.  It is rarely used.
• Level 3 criteria provide the highest assurance of product operability. Most TCGs require NEBS Level 3 for equipment operation in the central office, but not collocated equipment. This is the most used level.

In addition to the Telcordia Generic Requirements, a buyer may require American National Standards developed by the Alliance for Telecommunications Industry Solutions (ATIS). These standards, such as ATIS-0600319 Equipment Assemblies – Fire Propagation Risk Assessment or the ATIS-0600015 series of energy efficiency testing standards, are often referenced in the Telcordia GRs.

In addition, there are international standards for manufacturers that seek compliance for the global marketplace. Examples include the ETSI 300 019 and 300 386 series of standards dealing with the physical and EMC environments, respectively.

MET is a pioneer in NEBS testing, and will be offering our first East Coast NEBS Compliance Seminar in many years in October.  Registration is not yet open, but you can reserve a seat now by sending an email to info@metlabs.com .

Also, we will be at CTIA Wireless later this month.  Meet with us there.

In the U.S., wireless module approvals fall into one of three categories:

• Full modular approval – A radio module to be approved for use in any host and sold to anyone
• Limited modular approval – A radio module to be approved for restricted use
• Split modular approval – A radio module where the transmitter firmware is held on a host

FCC Full Modular Approval
Full approval is defined in FCC Part 15.212.  The module will have the FCC ID; any host incorporating the module will show that the module is contained within it: Contains FCC ID: XXXYYYYY. 

There are 8 criteria for full approval:

1. Transmitter must have its own shield
2. Must have buffered modulation/data inputs
3. Must have power supply regulation
4. Must meet Part 15 antenna requirements
5. Must be tested in stand-alone configuration
6. Must be labelled with the FCC ID
7. Must meet its own FCC rule part
8. Must meet RF exposure requirements

The module host must still comply with its own requirements (e.g. Part 15B, Verification or DoC).

FCC Limited Modular Approval
FCC limited approval is for modules that don’t meet all eight criteria for full approval.  Limited approval is possible when the host or end environment is known:

• The module will be certified for a range or series of devices, similar in construction
• The module will be certified for use by the grantee or an authorized OEM
• The module will be tested in a representative host

FCC Split Modular Approval
Split approval can only be certified by the FCC, and is included on the TCB Exclusion List.

For module approvals, Knowledge Database (KDB) 996369 is key.  Other important KDBs include:

• KDB 784748 contains labelling requirements
• KDB 447498 contains RF exposure, MPE and SAR test guidance
• KDB 616217 contains SAR host guidance

Canada IC
Canada IC modular approvals are to RSS-GEN section 3.2, with requirements and labelling similar to FCC.  Unlike FCC, unlicensed modules use the same eight criteria as licensed modules.

For limited modular approval, guidance comes from RSS-GEN section 3.2.3, and is also similar to FCC.

MET is an FCC TCB and an Industry Canada CB.

Europe R&TTE Directive
In the EU, there is no certification or modular approval, but rather Declaration of Conformity (DoC).

A module placed on the market should be fully assessed to the R&TTE Directive (Radio, EMC and Safety), either as an independent radio or as a radio component intended for use within a host.

There are not eight criteria, so the manufacturer must assess to all possible installation environments.  By CE Marking a module, you are stating that it will comply in its intended use and environment.

For integrating modules into a host, the host company is ultimately responsible for compliance, unlike with the FCC and IC.  However, previous testing may be taken into consideration by the module integrator.  If module testing is trusted for the DoC of host, the module’s Technical Construction File (TCF) becomes part of the host’s TCF.

For the R&TTE Directive, these guidance documents exist:

• ETSI TR 102 070-1 – Application of EMC standards
• ETSI TR 102 070-2 – Application of Radio standards
• R&TTECA, TGN 01 – Requirements for a Final Product that Integrates an R&TTE Directive Assessed Module

Read about the proposed changes to the R&TTE Directive.

Japan
“Modular approvals” do not appear in Japanese radio law.  However, in July 2012, MIC announced that a module could be certified as a radio device, even if it used soldered connections, if it was the type: WLAN, Bluetooth, Zigbee, etc.  In other words, a FCC 15.247 type of device.  It is not modular approval, but it does allow soldered modules to be certified as radios.

In February 2013, MIC announced that modular approvals will be integrated into Japanese radio law.  Requirements are being developed now.  Currently, there is no timeline or estimated implementation date.

For questions or for a modular approval quote, visit our Quote Center.

We will be at CTIA Wireless next month.  Request to meet with us.

Simultaneously, the new Customs Union Technical Regulation (CU TR) for most electrical products was enforced in Russia, Belarus and Kazakhstan.

Earlier issued GOST R certificates will be valid until March 15, 2015.  After that, the new EAC mark must be used.

There are a number of changes in the CU TR for manufacturers of mass-produced products.  Here are a couple of the most significant:

• The certification applicant must have a formal relationship (contract) with a Russian representative legal entity.  With GOST, this was not required.
• Mandatory factory audits are performed by a Russian certification body.  With GOST, a test lab could do this.

Following is a list of new Customs Union Technical Regulations for electrical products (all in Russian):

• On the Safety of Low-Voltage Equipment
• Electromagnetic Compatibility
• On Safety of Machinery Equipment 
• On Safety of Equipment for Explosive Atmospheres
• Safety of Lifts
• On Safety of Equipment Operating on Gaseous Fuels

Have questions about the change?  Ask Pat, our Compliance Expert, or Contact Us for an immediate need.

This Compliance Today blog post is supplied by MET Labs Russian partner Elmas Group.

In a Notice of Proposed Rulemaking issued last month, the FCC proposed a number of changes to its existing equipment authorization program. The key proposed changes include:

TCB Accreditation – Telecommunications certification bodies (TCBs) – like MET Labs – will be accredited in accordance with the requirements of ISO/IEC 17011 and ISO/IEC 17065. These standards replace ISO/IEC Guides 58, 61 and 65.

Testing Laboratories Accreditation – Laboratories that test equipment subject to certification or approval under any of its rules must be accredited to ISO/IEC 17025.

TCB Authority – The FCC will no longer directly issue any grants of equipment authorization. Instead, TCBs will authorize and deny all products subject to certification.

Post-Market Surveillance – For post-market surveillance, the FCC will specify the number and types of samples that a TCB must test.

Assessing TCB Performance – NIST will assess TCB performance. The Commission also outlined a process to address TCB non-performance issues.

Measurement Procedures – ANSI C63.10-2009 will be the procedure used to determine the compliance of intentional radiators, and ANSI C63.4-2009 will be the procedure for assessing unintentional radiators.

We understand these proposed changes are likely to go through without significant modification, but first there is a comment period to elicit feedback.  Comments on the Commission’s proposed rule changes are due by late March here.

Read the complete text of the FCC’s Notice of Proposed Rulemaking regarding important changes to its equipment testing and authorization program under Part 15 and Part 68.

MET Labs is an accredited testing laboratory and TCB.  Contact us for FCC Testing or Certification assistance.

There is a good mix of manufacturers, retailers, industry associations, and independent test labs here.  The U.S. Consumer Product Safety Commission (CPSC) is represented by over 50 employees.  MET Laboratories is a sponsor and an exhibitor.  If you are at ICPHSO, let’s meet: 410.949.1856

Yesterday featured an interesting session on “Tools for Understanding and Anticipating Product Failure.”  Tim Cassidy, a panelist and Senior Manager of Product Safety and Compliance at Best Buy, explained how product safety complaints from consumers are handled by retailers.  His conclusions:

• Real consumer data is messy – consumers report incomplete and often inaccurate information
• It’s not always clear what the best course of action is
• Often consumer motives are not related to safety – they just want a replacement product that works

Cassidy also explained under what circumstances Best Buy will engage in product “forensics”:

• When there is litigation against the retailer’s private label products
• When the retailer suspects a quality or reliability issue could have serious consequences
• As a double check against vendor analysis
• To deepen understanding of a particular technology or design

Best Buy will also engage in FMEA for product failure analysis.  FMEA stands for Failure Mode and Effect Analysis.  FMEA can include MTBF calculations, HALT testing, or design reviews.

For Best Buy, FMEA has two purposes:

• A means of knowing what happens when components fail
• Criticality analysis (CA) guides corrective measures resulting from FMEA work

Today is “CPSC Day” and features a keynote from Inez Moore Tenenbaum, U.S. CPSC Chairman.  The ICPHSO Meeting ends tomorrow.

If you are a product safety compliance professional, you’ll want to attend MET’s upcoming free webinar on Using the CB Scheme to Access the World Marketplace.

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.

NRCan proposes to de-couple Canada’s ENERGY STAR technical specifications from its Energy Efficiency Regulations.  NRCan intends to use the ENERGY STAR technical specification published by the United States Environmental Protection Agency (EPA) exclusively for ALL product categories (except fenestration products).  A one month commentary period revealed that the harmonization of technical specifications with the EPA was not an issue for the majority of Canadian manufacturers.

This change, however, will result in other changes:  using the EPA’s specification could result in manufacturers using test procedures which, at any given time, may not be identical to those used for Canada’s Energy Efficiency Regulations, for regulated products.  As such, NRCan will not be collecting data from manufacturers’ EERs to auto-qualify their products for ENERGY STAR designation.

Analysis by NRCan reveals that this decision will only impact a small subset of manufacturers who sell regulated products in Canada only – and for the most part, only for those product categories whose ENERGY STAR specification’s test procedure differs significantly from the one required in Canada’s Energy Efficiency Regulations.  These manufacturers may be required to pay for additional testing, in order to fulfill reporting obligations to both NRCan and the EPA.

Not changing: Canada’s Energy Efficiency Regulations stipulate that all prescribed energy-using products, imported or shipped inter-provincially for sale or lease in Canada, must bear an energy efficiency verification mark authorized by a certification body accredited by the Standards Council of Canada.  (See MET’s energy efficiency verification mark here).  The dealer of the energy-using product must ensure that an energy efficiency report is filed with NRCan for models available for sale or lease in Canada.

At the time that the ENERGY STAR Initiative was introduced into Canada in 2001, NRCan chose to set its own efficiency levels and testing procedures for some products subject to Canada’s Energy Efficiency Regulations, in order to harmonize them with those required for the Regulations.  As such, ENERGY STAR qualification was automatically given to products which met the higher efficiency level required by the Canadian ENERGY STAR specification (harmonized with NRCan’s Regulations).  Manufacturers wishing to designate products as ENERGY STAR qualified simply filled out voluntary fields in their EERs, and if their product met the specified level set by a database filter, they were listed as such.

Since that time, the number of product categories eligible for ENERGY STAR recognition has doubled, the frequency of technical specification updates or revisions has doubled, and NRCan has found that the efficiency levels of ENERGY STAR specifications in Canada and the United States are identical, regardless of the units of measure or the test procedures specified.

Products for sale or lease in Canada that are not subject to Energy Efficiency Regulations have always followed the EPA’s certification process in order to achieve ENERGY STAR qualification: 

• Manufacturers must submit their product for testing to an EPA-approved laboratory
• Testing results must be validated by an EPA-approved Certification Body (CB)
• The CB must seek ENERGY STAR designation on behalf of manufacturers whose products they have validated as meeting the EPA’s specifications for ENERGY STAR qualification
• The product is recognized by the EPA and listed on their Web site

Moving forward, NRCan proposes that the above steps apply to all products which are currently eligible for ENERGY STAR designation in Canada, with the exception of fenestration products and HRVs.  This means that EPA-recognized Certification Bodies must submit data to the EPA on behalf of their clients, for all products that manufacturers wish to be recognized as ENERGY STAR qualified.  It also means that in order to do so, the data must come from an EPA-certified lab.

Comments and questions should be sent to NRCan’s ENERGY STAR Chief Dianna Miller at Dianna.Miller@nrcan-rncan.gc.ca.  Include “ENERGY STAR Canada proposed changes” in your subject line.

MET Labs is an EPA-approved lab and certification body.  Get a quote now.

EUANB is the Notified Body Group for the EMC Directive and is composed of members who are a Notified Body (NB) in the EEA Countries or a Conformity Assessment Body (CAB) in a country where the EU has a mutual recognition agreement in place.  MET Labs is an EMC Directive NB by virtue of a US-EU mutual recognition agreement (MRA).

The Commission has sent the revised document for discussion by the Council and EU Ministers, as well as by the EU Parliament. It is expected that the final revised EMC Directive will be published in the first quarter of 2013. There will then be a period during which each EU Member State will be transposing the Directive into national law.  The latest available proposal contains a transition period of 2 years after the Directive has become operational.

In the revised EMC Directive, there are two modules made available to the manufacturer:

1. Module A – Self certification, where the manufacturer determines compliance and issues its Declaration of Conformity (DoC)
2. Modules B+C – Notified Body issues EU-Type Certificate (Module B), manufacturer then issues DoC (Module C)

A draft template for the EU‐Type Examination Certificate will be developed.

Much of the proposed changes center on a new role for Notified Bodies, as detailed following:

• The NB shall prepare an evaluation report explaining how compliance was determined.
• If documents are satisfactory, NB shall then issue an EU-Type Examination Certificate. An “opinion” is no longer being issued.
• If documents are not satisfactory, NB shall issue a letter of refusal.
• The manufacturer must choose a single NB and declare that no other NB has been used.  This means that “NB Shopping” will not be allowed.
• The manufacturer specifies which parts of the Directive the NB is going to review, and the NB role is then limited to that aspect of the review.
• There is a new NB role that involves monitoring. Specifically, the NB must stay up‐to‐date with the “state of the art” and determine if the changes might impact the approved type. If so, they must contact the client manufacturer.
• The NB must inform the Notifying Authority (e.g. NIST for U.S. NBs) about issued or withdrawn certificates and periodically make available a list of the refused, suspended or otherwise restricted certificates to the Notifying Authority.
• There is a new requirement for information sharing with other NBs and with the Commission and market surveillance authorities.
• Record keeping – the NB shall keep the technical file and related documents for 10 years or until the EU‐Type Certificate is withdrawn.

The proposed date of the next meeting is Friday, May 3, 2013 in Amsterdam in conjunction with the R&TTECA meeting on May 2.

Questions about the proposed changes?  Ask Pat, our regulatory compliance expert. 

For EMC Directive compliance today, request a quote to support a Declaration of Conformity and refer to this guide to assist with the common application of the Directive 2004/108/EC.

Credit: NIST provided much of the information provided in this post.

At the meeting, MET Laboratories was approved as a R&TTE Compliance Association member.  (This is unrelated to R&TTE Notified Body status – a designation that MET already had).

The European Commission issued a formal proposal for revisions to the Directive on October 17, 2012. The final revised legal text of the Directive is expected to be issued within 18 months, and then there will likely be an 18-month period during which each EU Member State will be transposing the Directive into national law.

The Directive was revised to align it with the New Legislative Framework (NLF) and to improve specific technical elements.

Key revisions contained in the proposal are as follows:

New Legislative Framework
NLF alignment issues will be common for all Directives:

• New responsibilities for manufacturers, authorized representatives, importers, and distributors
• Mandatory single Declaration of Conformity (DoC) issued by the manufacturer
• Requirements for the Technical Construction File (TCF)
• Translation of the TCF upon request
• Safeguard clauses and formal non-compliances
• Common DoC template

Specific Technical Changes
The proposed Directive also includes technical changes, some of which follow:

• Change to Scope
• Definition of Radio Equipment
• Provision for software-defined radio
• New registration scheme for radio equipment
• Extra information in user manual
• Simplified DoC allowed
• Geographic information in package
• Notified Body will only be required if there is no harmonized standard under Article 3.2
• NB ID is only needed under the Quality Assurance Module
• No notification of Member States with placement on the market
• Alert mark is formally required
• CE mark no longer required in the Manual – only on product and packaging
• For evaluation of Safety/EMC aspects, manufacturer has the following choices: OEM declaration, NB involvement and OEM Certificate to Type, or Full Quality Assurance Module by NB
• For evaluation of Radio aspects using full harmonized standards, manufacturer has the same 3 options.  If not using full harmonized standards, OEM declaration is not allowed.

The proposed date of the next meeting is Thursday, May 2, 2013 in Amsterdam.

Questions about the proposed changes?  Ask Pat, our regulatory compliance expert. 

For product safety compliance engineers, note our upcoming complimentary webinars on Using the CB Scheme for International Product Safety Certification and North American Product Safety Certification for EU Manufacturers. 

Many thanks to NIST, which provided much of the information provided in this post.