NTS News Center

Latest News in Testing, Inspection and Certification

NTS News Center - Latest News in Testing, Inspection and Certification

Changes to Certification Process in Ecuador

ARCOTEL in Ecuador issued a new regulation about the homologation process. The biggest impact to the changes are highlighted below:

  • No in-country testing is required. The changes have removed the requirement for testing, therefore no samples are required for submission/certification to ARCOTEL in almost all cases
  • Photographs of the device will now be required and there are specific requirements for the photos including external, internal and label views. These cannot be photos from test reports or marketing material.
  • The certificates will be issued by class. This could mean that a product will fall into multiple classes and require multiple certificates. The classes are as follows:
    • Terminals for the Advanced Mobile Service (SMA):
    • Terminals for the Bearer Service (P)
    • Terminals for the Fixed Telephone Service (STF)
    • Terminals for the Telecommunications Satellite Service (TTS)
    • Terminals for Internet access. (AI)
    • Trunked terminals for the Service. (T)
    • Terminals for the Communal Service (C)
  • Products that do not fall into mandatory scope can obtain obtain a certificate of recognition of being outside the scope of the regulation

Contact our NTS International Approvals Team at IATeam@nts.com if you need more information or assistance.

Taiwan Implements Requirements for RoHS in Electronic Equipment

Taiwan has recently implemented requirements for RoHS (Restrictions of Hazardous Substances) in electronic equipment. These requirements are aligned with the European RoHS directive excluding phthalates.

The new requirements will be enforced for some electrical products beginning July 1, 2017 as part of the mandatory assessment scheme by the authority BSMI. There is a proposal to add 92 more categories of electrical products by Jan 1, 2018.

Products will be assessed to CNS 15663 in addition to the Safety and EMC mandatory conformity assessments. There is a marking change and a requirement of a table to be available with the product.

For more information on the product types that are in scope for phase 1, refer to the following documents: http://www.bsmi.gov.tw/wSite/public/Data/f1436161147146.pdf

Contact our NTS International Approvals Team at IATeam@nts.com if you need more information or assistance.

Upcoming Changes for Wireless Equipment – EN 301 489-x

EN 301 489 series of standards for EMC testing of radio equipment are being revised. Although these EMC standards are intended for radio equipment, they are not planned to be listed in the Official Journal of the European Union under the Radio Equipment Directive 2014/53/EU (RED). Depending on your risk analysis results, the use of the new versions of the EN 301 489-x standards may fully cover the essential requirement of article 3.1(b) of RED for all types of radio equipment.

Depending on the results of the risk analysis, manufacturers should follow the new version of EN 301 489-1 and the particular EN 301 489 standard requirements and update their test reports for their current products as soon as possible. Testing may be necessary since there may be changes in the requirements. In particular, the radiated immunity frequency range for many but not all products has been extended to 6 GHz.

Manufacturers of radio equipment can use the R&TTE Directive – 1999/5/EC (Radio and Telecommunication Terminal Equipment Directive) and it’s harmonized standards, such as EN 301 489-1 V1.9.2 and EN 301 489-3 v1.6.1 in their Declaration of Conformities (DoC) until June 12, 2017.

After this date, manufacturers of any radio device who places product on the market in any country which requires CE marking, have to use RED (Radio Equipment Directive 2014/53/EU) in their DoC. This is applicable for all new products as well as for products that are currently being marketed and intended to be placed on the market after this date. Products with DoCs that are not updated to the RED are not to be placed on the European Union market after June 12, 2017.

Upcoming Changes for Transmitters and Receivers for Private Mobile Radio (PMR) service in the European Union. EN 300 113

By Deniz Demirci, Senior Wireless / EMC Engineer, NTS Silicon Valley

Manufacturers of radio transmitters and receivers used in stations in the Private Mobile Radio (PMR) service, operating on radio frequencies between 30 MHz and 1 GHz, intended for sale in the EU should take note of some important changes.

Currently, manufacturers of these type of equipment can still use the R&TTE Directive 1999/5/EC (Radio and Telecommunication Terminal Equipment  Directive) and it’s harmonized standard EN 300 113-2 V1.5.1 in their Declaration of Conformities (DoC) until June 12, 2017. After this date, manufacturers of any radio device that enters any country which requires CE marking, have to use the RED (Radio Equipment Directive – 2014/53/EU) in their DoC. This is applicable for all new products as well as for products that are currently being sold and are intended to be placed on the market after this date. Products for which DoCs are not updated to the RED are not to be placed on the European Union market after June 12, 2017.

The new version of the standard for Radio Equipment Directive was published in the ETSI web site as EN 300 113 V2.2.1 and it is listed in the Official Journal (OJ) of the EU (Harmonized).

Our recommendation to manufacturers is to schedule tests for the new requirements as soon as possible in order to update their test reports for the new directive.

The receiver performance requirements in the standard, which were not part of essential test suites before, are now unconditionally applicable to all receivers and transceivers in order to align with the Article 3.2 of the directive.

The new essential receiver test suits are;

  • Receiver maximum usable sensitivity1.
  • Receiver error behavior at high input levels.
  • Receiver co-channel rejection.
  • Receiver adjacent channel selectivity1.
  • Receiver spurious response rejection.
  • Receiver intermodulation response rejection.
  • Receiver blocking or desensitization.
  • Duplex operation receiver tests.

Note 1: The tests have to be repeated in extreme voltage and temperature conditions with every available channel spacing and modulation.

Manufacturers who cannot or decide not to use harmonized radio standards in their DoCs must have a Notified Body Type Examination & Certificate in order to presume compliance with the directive. The Notified Bodies have to follow Article 3.2 of RED in their type examination evaluations and will ask for evidence of presumption of conformity which must include a demonstration that the product meets the requirements of the directive which includes spectrum protection measures such as the performance characteristics of receivers.

Upcoming Changes for Wireless Equipment operating in the 2.4 GHz Band EN 300 328

By Deniz Demirci, Senior Wireless / EMC Engineer, NTS Silicon Valley

EN 300 328 V2.1.1 was harmonized and listed in the Official Journal of the European Union under Directive 2014/53/EU for RED (Radio Equipment Directive) on January 13, 2017. This version of the standard covers the essential requirements of article 3.2 of RED for 2.4 GHz ISM band WiFi, Bluetooth, and other Wideband transceivers.

Manufacturers of these types of equipment can still use the R&TTE Directive – 1999/5/EC (Radio and Telecommunication Terminal Equipment Directive) and its harmonized standard EN 300 328 V1.9.1 in their Declaration of Conformities (DoC) until June 12, 2017.

After this date, manufacturers of any radio device who enter any country which requires CE marking, have to use the RED (Radio Equipment Directive 2014/53/EU) in their DoC.

This is applicable for all new products as well as for products that are currently being marketed and intended to be placed on the market after this date. Products which DoCs are not updated the RED are not to be placed on the European Union market after June 12, 2017.

Manufacturers should follow EN 300 328 V2.1.1 requirements and update their test reports for their current products as soon as possible since there is significant change in the essential requirements.

  • The Receiver Blocking requirement is unconditionally applicable to all radio equipment regardless of receiver category or adaptivity capability. This is a major change from the previous version of the standard.

Since the Receiver Blocking was previously conditionally applicable to the adaptive equipment only and the test methods as well as the performance criteria were different, most products may have never been evaluated for this requirement before.

Note:  After June 12, 2017, any radio device which the standards are not yet harmonized and listed in the Official Journal of the European Union, must have a Notified Body Opinion/Type Examination Certificate in order to presume compliance with the essential requirements in Article 3.2 of Directive 2014/53/EU – RED.

Changes for Medical Equipment IEC 60601-1

UL 60601-1 and CAN/CSA C22.2 No. 60601-1

With the publication of the fourth edition of IEC 60601-1-2 [1] and its European equivalent, EN 60601-1-2 [2] being listed in the Official Journal, the EMC requirements for medical electronic devices changed. Products that will remain in production after the mandatory effective date of December 31, 2018 may require redesign to comply with the requirements of the fourth edition. Changes in design will also affect the FDA approval. Even if no changes are required, testing will need to be performed to assess the product’s performance in light of the expanded scope of testing of this new edition for the EU. There is no grandfathering of equipment that was assessed using the third edition of the standard in the EU. A presumption of conformity with the essential requirements of the Medical Device Directive (MDD) may only be assumed if the new edition is employed after the transition date. For the sake of brevity, whenever I refer to the standard, I am talking about the fourth edition of IEC 60601-1-2 and EN 60601-1-2.

Test Requirements: Emissions

The emissions requirements are found in Table 2 of the standard and cover conducted and radiated emissions using the limits and methods of CISPR 11, harmonic distortion using IEC 61000-3-2 and voltage fluctuations and flicker using IEC 61000-3-3. The application of IEC 61000-3-2 and IEC 61000-3-3 depends on the use environment. Different requirements may be necessary based on other uses, such as in transportation.

Test Requirements: Immunity

Performance Requirements

As you read the standard, you eventually get to the section on immunity requirements for ME equipment and systems. The test levels to be used are described in the standard for two types of environments. Use of higher or lower values may be used depending on the outcome of the risk management process.

At first glance, you may decide that degradations of performance are not allowed during the tests and that your product will not be able to meet a performance criteria without a significant redesign. However, as stated, the intent of this section is to describe these degradations in light of the Essential Performance and Basic Safety of the product being tested. The product is allowed to exhibit degradations that do not affect Essential Performance and safety during the tests.

Basic Safety and Essential Performance

What are Basic Safety and Essential Performance? These are defined terms in the standard IEC 60601-1. Basic Safety is “freedom from unacceptable risk directly caused by physical hazards when ME equipment is used under normal condition and single fault condition.” Essential Performance is “performance necessary to achieve freedom from unacceptable risk.” According to the standard, a risk management process shall be used to identify risks from electromagnetic disturbances in addition to any other risks.” Annex F provides additional guidance for including the risks from electromagnetic disturbances in the risk management process described in ISO 14971. The risk management report produced by the process provides the description of pass fail criteria for each function of the product and how the basic safety and essential performance will be monitored during each immunity test. This information is incorporated in the EMC test plan. This test plan is required prior to starting any EMC testing. An example is provided in Annex G of the standard.

The implication here is that you should perform a risk analysis (see Annex F of the standard for more details) prior to establishing the compliance criteria to avoid the need to perform more tests against more stringent criteria. Depending on the class of device as determined from Annex I of the medical device directive, a notified body will likely need to be consulted in determining the performance criteria to apply based on the risk analysis. The establishing of the performance criteria is crucial to evaluating the observations made of product operation during immunity tests and in determining the methods used to monitor the product. The risk analysis must account for all manners of use of the product. After assessing all the risks and determining the residual risk level, you enumerate the compliance criteria. Examples of criteria can be found in Annex I of the standard.

Tests

Now that you have established the compliance criteria you will use during the immunity tests, you are ready to test. Not so fast. The standard requires a completed test plan be prepared prior to the start of formal testing. The recommended content of the test plan is given in Annex G of the standard. The standard includes the normal set of immunity tests that are to be applied and describes test levels for special environments in Annex E. The tests are the same tests that are applied for other products such as radio equipment, networking equipment and information technology equipment except that the standard incorporates some specific test application guidance notes that require special consideration. Tables 4 through 8 list the immunity tests applicable to medical devices and the basic levels for both professional healthcare facility and home healthcare environments.

The list may include additional tests and the test specification column may change based on the type of equipment to be evaluated and particular standard that would therefore apply. It is beyond the scope of this paper to present the appropriate specifications for all medical devices. However, some examples can serve to illustrate the point. EN 60601-2-24, particular to infusion pumps, modifies the test specifications: radiated immunity test level changes to 10 V/m even if the product is for professional healthcare environments; magnetic immunity test level increases to 400 A/m. EN 60601-2-10, particular to nerve stimulators, adds that patient leads are to be placed in saline solution during testing. EN 60601-2-2, particular to HF surgical equipment, modifies the compliance criteria and the emissions test configuration.

To evaluate the DFS functions of a system the regulatory standards describe waveforms to be used when evaluating DFS. These waveforms are defined in terms of the number of pulses, the pulse width and the pulse repetition frequency (or period) for the radar signal. The pulses may be modulated with an FM chirp, and may contain pulses of different widths and different periods.  Manufacturers should always bear in mind that their radar detection algorithms should be designed to detect all radar systems.

Table 1: Immunity Tests
Environmental Phenomena Test Specification Test Setup
Electrostatic Discharge ±8kV (Contact)

±2, 4, 8, 15kV (Air)

EN 61000-4-2
RF Fields 80 – 2700 MHz

3V/m (professional healthcare facilities) or 10V/m (home use)

80% AM, 1 kHz

EN 61000-4-3
RF Proximity fields Various frequencies up to 28 V/m EN 61000-4-3
Fast transients

Power

Signal

5/50ns, 100 kHz

±2.0 kV

±1.0 kV

EN 61000-4-4
Surges

Line to PE

Line to Line

Outdoor SIP/SOP

1.2/50μS

±0.5, 1.0 & 2.0kV

±0.5 & 1.0 kV

± 2 kV line to ground

EN 61000-4-5
RF Voltage (Conducted Immunity) 0.15 – 80 MHz

3V (6V in some frequency ranges)

80% AM, 1 kHz

EN 61000-4-6
Magnetic Fields* 50 Hz

30A/M

EN 61000-4-8
Voltage Dips 100%, 0.5 cycles at various phase angles

100%, 1 cycle

30%, 25/30 cycles

EN 61000-4-11
Voltage Interruption 100% for 250/300 cycles EN 61000-4-11
*Applies only if the product has magnetically sensitive components or circuity

 

The standard has higher test levels for ESD and magnetic field immunity, magnetic field immunity may not be needed, additional RF field immunity requirements with potentially higher levels and additional VDI requirements compared to the previous edition. It also makes clear the need for a test plan prior to testing. Depending on the product, the test plan may need to include other tests or test levels that will also need to be evaluated based on the intended use of the product.

Basic Immunity Test Modifiers

For some of the immunity tests, the standard specifies modifications to the methods of the basic standards listed in table 1 above.

For example:

The dwell time at each frequency step for conducted and radiated immunity must be set to allow the product to be fully evaluated at each step. Dwell times exceeding 15 seconds are not uncommon.

Electrical fast transient tests are not performed on patient cables.

During conducted emissions, electrical fast transient/burst and conducted immunity tests, patient coupled parts shall be terminated with artificial hands.

CDNs shall not be used for conducted immunity tests on patient leads.

Power input voltage and frequency are specified for each test in Table 1 of the standard. In most cases, the tests are performed at one voltage and one frequency from the ranges of voltage and frequency for which the product is rated. Voltage dips and short interruption tests shall be performed at the minimum and maximum rated voltages if the product has rated voltage range ≥ 25% of the minimum rated voltage.

Product Information

Assuming that you have performed all of the appropriate emissions and immunity tests using the compliance criteria specified in the test plan with acceptable results, the requirements of the standard are still not yet fulfilled. The standard requires information about EMC to be included in the instructions furnished to the user. These can be found in Clause 5. The tables of information there were part of the third edition of the standard are not included in the fourth edition.

The instructions shall also provide technical information such as compliance information for each test and test levels for immunity. The justification for using the levels other than described in the standard shall be provided in the instructions. Instructions necessary for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances shall also be provided.

Radio Functions in Medical Devices

If a radio is provided with the product either internally or as a separate unit, the radio part of the device or system may only need approval against the applicable radio standards. However, if the function of the radio affects the essential performance of the system, then the radio and medical device both must be evaluated for immunity using the medical equipment standard.

The emissions of the radio part must comply with the medical equipment standard except in the dedicated transmission band. This means that spurious emissions of the radio must meet the CISPR 11 limits, which in most cases are more restrictive than the spurious emissions limits for the radio device.

Summary

The new edition of EN 60601-1-2 presents many challenges to manufacturers. From the beginning of the design process, manufacturers are encouraged to seek assistance from test labs and certification agencies to understand the provisions of EN 60601-1-2 as they apply to their specific product.

References

[1] IEC 60601-1-2:2014, International Standard for Medical electric equipment – Part 1-2: General requirements for basic safety – Collateral standard: Electromagnetic compatibility – Requirements and tests.

[2] EN 60601-1-2:2015, European Standard for Medical electric equipment – Part 1-2: General requirements for basic safety – Collateral standard: Electromagnetic compatibility – Requirements and tests.

Upcoming Changes for Wireless Equipment in the 2.4 GHz Band EN 300 328

By Deniz Demirci, Senior Wireless/EMC Engineer at NTS Silicon Valley

EN 300 328 V2.1.1 was harmonized and listed in the Official Journal of the European Union under Directive 2014/53/EU for RED (Radio Equipment Directive) on January 13, 2017. This version of the standard covers the essential requirements of article 3.2 of RED for 2.4 GHz ISM band WiFi, Bluetooth and other Wideband transceivers.

Manufacturers of these type of equipment can still use R&TTE Directive 1999/5/EC (Radio and Telecommunication Directive) and it’s harmonized standard EN 300 238 V1.9.1 in their Declaration of Conformities (DoC) until June 13, 2017.

After this date, manufacturers of any radio device who enters any country which requires CE marking, have to use RED (Radio Equipment Directive 2014/53/EU) in their DoC.

This is applicable for all new products as well as for products that are currently being marketed and intended to be sold after this date. Products which DoCs are not updated by this date, should not be sold in the European Union.

Manufacturers should follow EN 300 328 V2.1.1 requirements and update their test reports for their current products as soon as possible since there is significant change in the essential requirements;

  • The Receiver Blocking Requirement is unconditionally applicable to all radio equipment regardless of receiver category or adaptivity capability. This is a major change from the previous version of the standard.

Since the Receiver Blocking was conditionally applicable to the adaptive equipment only and the test methods as well as the performance criteria were different, most products may have never been evaluated for this requirement before.

Note: After June 13, 2017, any radio device which the standards are not yet harmonized and listed in the Official Journal of the European Union, must have a Notified Body Opinion/Type Examination Certificate in order to presume compliance with the essential requirements in Article 3.2 of Directive 2014/53/EU – RED.

For more details and information on how to update test reports for the Radio Equipment Directive, other specification interoperability scenarios or test, design and engineering help is available by contacting NTS at 800-270-2516 or emailing sales@nts.com.

Radio Equipment Directive (RED) Transition Time Coming Soon

Is your organization ready for the transition to the Radio Equipment Directive (RED)? RED must be employed for all products included in its scope and not yet placed on the EU market after June 12, 2017. Even products that were already being sold as compliant with the R&TTE directive must comply with the RED to continue to be placed on the market after this date.

The EU Commission has continued to add standards to the harmonized standards list, visit the EU Commission website to review the latest updates, as of March 10, 2017.

To learn more, visit our RED page or contact us today!

Taiwan: Emissions Testing for Information Technology Equipment, CNS 13438 Requirements

by Wayne Fisher, EMC Lab Manager,
NTS Silicon Valley

Manufacturers of Information Technology Equipment (ITE) intended for sale in Taiwan should take note that as of October 1, 2010 EMC testing requirements under emissions standard CNS 13438 have changed.

The Bureau of Standards, Metrology and Inspection (BSMI) requires radiated emissions both from 30MHz to 1GHz and conditions requiring testing upwards of 6GHz. Additionally, con­ducted emissions on telecommunication ports are required on all networking ports (IE: Ethernet).

The radiated emissions above 1GHz requirements are based on Amendment 1:2005 of CISPR 22:2005, which means testing is performed in a free space facility.

  • If the highest internal frequency source of the device under test is less than 108MHz radiated measurements are only performed up to 1000MHz.
  • If the device has an internal frequency source between 108MHz and 500MHz, the measurement shall only be made up to 2GHz.
  • If the frequency is between 500MHz and 1GHz, the measurement shall be only up to 5GHz.
  • If the frequency of the internal sources is above 1GHz the measurement shall be up to 5 times the highest frequency or 6GHz, whichever is less.

The Conducted Emissions on Telecommunication Ports requirements are the same as those in CISPR 22 with multi-speed ports operating at their highest data rate. Where there are many electrically identical telecommunication ports, multiple pre-scans may be required to determine the ‘worst case’ port for final evaluation.

The testing is performed with the device under test operating from line voltages consistent with Taiwan. For Class A devices, testing must be performed at both 110VAC and 220VAC or 230VAC, 60Hz. For Class B devices, testing need only be performed at 110VAC, 60Hz.

Products that were approved prior to October 1, 2010 will be accepted into the Taiwan market until their certificate is subject to renewal or if changes have been made to a product that needs re-certification after that date. At that point in time, products will need to demonstrate compliance with the new requirements.

New rules currently under draft may be implemented this year have indicated that all approvals must adhere to RoHS rules otherwise certificates will expire at the end of this year. Evidence of RoHS certification for the EU will be accepted by Taiwan towards this requirement.

Contact us at sales@nts.com or call 800-270-2516 to know more about the steps you need to take to ensure compliance of your ITE products with the requirements of Taiwan.

Dynamic Frequency Selection (DFS) in 5GHz Unlicensed Bands

An Overview of Worldwide Regulatory Requirements

The advent of the 802.11a wireless market and the constant push to open up spectrum for unlicensed use required that a mechanism be implemented for spectrum sharing. Dynamic Frequency Selection (DFS) is the mechanism that was adopted to allow unlicensed devices to use the 5 GHz frequency bands already allocated to radar systems without causing interference to those radars. The concept of DFS is to have the unlicensed device detect the presence of a radar system on the channel they are using and, if the level of the radar is above a certain threshold, vacate that channel and select an alternate channel.

The regulatory requirements for DFS, along with requirements along with Transmit Power Control (TPC), have been adopted in Europe, the United States of America, and many other geographical areas. The following is an overview of the current DFS requirements for Europe, the USA, Canada, Taiwan, Australia, and Japan.

Click here to download and review this white paper.