Category Archives: Europe

The EU has published a new toy safety standard EN 71-12 2016 N-Nitrosamines and N-nitrosatable substances.

Product Recall Analysis for Apparel and Footwear – November 2016

Recall Cases Analysis of Apparel and Footwear – October 2016

Radio Equipment Directive Harmonised Standards will not be ready.

The radio equipment directive came into force on the 13th of June this year with a transition period finishing on the 13th of June 2017.

The problem is that many of the relevant harmonised standards which manufacturers may use to prove compliance with the directive and self certify their products will not be ready by the 13th of June 2017.

The following list shows the standards which will not be ready in time:

Standard Description Adoption OJ Publication
EN 305 550 Short Range Devices (SRD); Radio equipment to be used in the 40 GHz to 246 GHz frequency range 2018-04-10 2018-08-07
EN 303 980 Satellite Earth Stations and Systems (SES); Harmonized EN for fixed and in-motion Earth Stations communicating with non-geostationary orbiting systems (NEST) in the 11 GHz to 14 GHz frequency bands 2017-10-02 2018-01-29
EN 303 660 Radio equipment to be used in the frequency range below 9kHz 2018-04-10 2018-08-07
EN 303 490 Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and Peripherals (LP-AMI-P) operating in the 2,4 GHz ISM band 2018-04-10 2018-08-07
EN 303 489 Air Traffic Control Surveillance; Wide Area Multilateration (WAM) systems 2018-07-18 2018-11-14
EN 303 454 Metal and object detection sensors in the frequency range 1kHz to 148.5kHz 2018-04-10 2018-08-07
EN 303 447 Inductive robotic mowers in the frequency range 0Hz to 148.5kHz 2017-08-04 2017-12-01
EN 303 446-2 ElectroMagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment Part 2: Specific conditions for equipment in industrial locations 2018-01-16 2018-05-15
EN 303 446-1 ElectroMagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 1: Specific conditions for equipment in residential locations. 2017-08-13 2017-12-10
EN 303 417 Wireless power transmission using technologies other than radio frequency beam 2017-08-13 2017-12-10
EN 303 413 Satellite Earth Stations and Systems (SES); Global Navigation Satellite System (GNSS) receivers; Radio equipment operating in the 1164 MHz to 1350 MHz and 1559 MHz to 1610 MHz frequency bands 2018-05-07 2018-09-03
EN 303 405 Land Mobile Service; Analogue and Digital PMR446 Equipment 2017-04-22 2017-08-19
EN 303 402 Maritime mobile transmitters and receivers for use in the MF and HF bands 2017-07-24 2017-11-20
EN 303 364-3 Primary Surveillance Radar (PSR) 2017-10-07 2018-02-03
EN 303 364-2 Primary Surveillance Radar (PSR) 2018-04-10 2018-08-07
EN 303 364-1 Primary Surveillance Radar (PSR) 2018-04-10 2018-08-07
EN 303 363 Secondary Surveillance Radar (SSR) 2017-12-12 2018-04-10
EN 303 348 Induction loop systems intended to assist the hearing impaired in the frequency range 10 Hz to 9 kHz 2017-04-15 2017-08-12
EN 303 347-3 Meteorological Radars 2018-03-18 2018-07-15
EN 303 347-2 Meteorological Radars 2017-10-17 2018-02-13
EN 303 347-1 Meteorological Radars 2018-03-18 2018-07-15
EN 303 346 Multi-Static Primary Surveillance Radar (MSPSR) 2018-04-10 2018-08-07
EN 303 345 Broadcast Sound Receivers 2017-04-15 2017-08-12
EN 303 340 Digital Terrestrial TV Broadcast Receivers 2018-08-07 2018-12-04
EN 303 316 Broadband Direct Air-to-Ground Communications 2017-06-02 2017-09-29
EN 303 276 Electromagnetic compatibility and Radio Spectrum (ERM) Maritime Broadband Radio (MBR) links for ships and fixed installations engaged in off-shore activities 2018-04-10 2018-08-07
EN 303 258 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless industrial automation; Radio equipment to be used in the 5,725 GHz to 5,875 GHz frequency range with power levels ranging up to 400 mW 2018-04-10 2018-08-07
EN 303 213-5-2 Advanced Surface Movement Guidance and Control System (A-SMGCS) 2017-12-03 2018-04-01
EN 303 213-5-1 Advanced Surface Movement Guidance and Control System (A-SMGCS) 2017-12-03 2018-04-01
EN 303 132 Maritime low power VHF personal locating beacons employing Digital Selective Calling (DSC) 2017-08-24 2017-12-21
EN 302 885 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands with integrated handheld class H DSC 2017-08-24 2017-12-21
EN 302 752 Electromagnetic compatibility and Radio spectrum Matters (ERM); Active radar target enhancers 2019-04-17 2019-08-14
EN 302 686 Intelligent Transport Systems (ITS); Radiocommunications equipment operating in the 63 GHz to 64 GHz frequency band 2019-03-20 2019-07-17
EN 302 608 Short Range Devices (SRD); Radio equipment for Eurobalise railway systems 2017-08-13 2017-12-10
EN 302 567 WAS/RLAN systems; Multiple-Gigabit WAS/RLAN equipment operating in the 60 GHz band 2017-12-18 2018-04-16
EN 302 536 Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals 2017-08-14 2017-12-11
EN 302 510 Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz 2017-06-17 2017-10-14
EN 302 502 Wireless Access Systems (WAS); 5,8 GHz fixed broadband data transmitting systems 2017-09-12 2018-01-09
EN 302 326-2 Fixed Radio Systems; Multipoint Equipment and Antennas 2018-09-22 2019-01-19
EN 302 296 Digital Terrestrial TV Transmitters 2017-07-07 2017-11-03
EN 302 288 Short Range Devices; Transport and Traffic Telematics (TTT); Short Range Radar equipment operating in the 24GHz range 2017-07-22 2017-11-18
EN 302 245 Transmitting equipment for the Digital Radio Mondiale (DRM) broadcasting service 2018-05-20 2018-09-16
EN 302 217-2 Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2: Digital systems operating in frequency bands from 1,3 GHz to 86 GHz 2017-03-31 2017-07-28
EN 302 077 Transmitting equipment for the Terrestrial – Digital Audio Broadcasting (T-DAB) service 2018-04-15 2018-08-12
EN 302 065-5 Short Range Devices (SRD) using Ultra Wide Band technology (UWB) 2017-08-14 2017-12-11
EN 302 018 Transmitting equipment for the Frequency Modulated (FM) sound broadcasting service 2017-11-07 2018-03-06
EN 302 017 Transmitting equipment for the Amplitude Modulated (AM) sound broadcasting service 2017-12-12 2018-04-10
EN 301 929 VHF transmitters and receivers as Coast Stations for GMDSS and other applications in the maritime mobile service 2017-08-22 2017-12-19
EN 301 908-3 IMT cellular networks 2018-01-16 2018-05-15
EN 301 908-18 IMT cellular networks 2018-01-16 2018-05-15
EN 301 908-14 IMT cellular networks 2018-04-17 2018-08-14
EN 301 908-10 Electromagnetic compatibility and Radio spectrum Matters (ERM); Base Stations (BS), Repeaters and User Equipment (UE) for IMT-2000 Third-Generation cellular networks 2018-05-01 2018-08-28
EN 301 893 5 GHz high performance RLAN 2017-10-03 2018-01-30
EN 301 598 White Space Devices (WSD); Wireless Access Systems operating in the 470 MHz to 790 MHz TV broadcast band 2018-04-19 2018-08-16
EN 301 511 Global System for Mobile communications (GSM); Mobile Stations (MS) equipment 2017-08-14 2017-12-11
EN 301 489-9 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 9: Specific conditions for wireless microphones, similar Radio Frequency (RF) audio link equipment, cordless audio and in-ear monitoring devices 2017-06-02 2017-09-29
EN 301 489-53 ElectroMagnetic Compatibility (EMC) – standard for radio equipment and services Part 53: Specific conditions for terrestrial analogue and digital broadcasting transmitters 2017-12-12 2018-04-10
EN 301 489-52 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 52: Specific conditions for Cellular Communication Mobile and portable (UE) radio and ancillary equipment 2017-08-12 2017-12-09
EN 301 489-35 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands 2017-06-02 2017-09-29
EN 301 489-3 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz 2017-06-02 2017-09-29
EN 301 489-29 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands 2017-06-02 2017-09-29
EN 301 489-27 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) 2017-06-02 2017-09-29
EN 301 489-22 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services Part 22: Specific conditions for ground based VHF aeronautical mobile and fixed radio equipment 2018-01-11 2018-05-10
EN 301 489-2 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 2: Specific conditions for radio paging service equipment 2017-12-12 2018-04-10
EN 301 489-17 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems 2017-02-04 2017-06-03
EN 301 357 Cordless audio devices up to 2 000 MHz 2018-04-10 2018-08-07
EN 301 178 Portable Very High Frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands (for non-GMDSS applications only) 2017-08-13 2017-12-10
EN 301 025 VHF radiotelephone equipment for general communications and associated equipment for Class “D” Digital Selective Calling (DSC) 2017-08-18 2017-12-15
EN 300 720 Ultra-High Frequency (UHF) on-board vessels communications systems and equipment 2017-07-15 2017-11-11
EN 300 718-3 Avalanche Beacons; Transmitter-receiver systems 2017-07-16 2017-11-12
EN 300 718-2 Avalanche Beacons; Transmitter-receiver systems 2017-07-16 2017-11-12
EN 300 471 Land Mobile Service; Rules for Access and the Sharing of common used channels by equipment complying with EN 300 113 2018-03-18 2018-07-15
EN 300 454-2 Wideband audio links 2018-04-10 2018-08-07
EN 300 422-4 Wireless Microphones; Audio PMSE up to 3 GHz; Part 4: Assistive Listening Devices including personal sound amplifiers and inductive systems up to 3 GHz 2018-04-10 2018-08-07
EN 300 224 Paging service 2017-12-12 2018-04-10
EN 300 220-2 Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz 2017-12-14 2018-04-12
EN 300 113 Land Mobile Service; Radio equipment intended for the transmission of data (and/or speech) using constant or non-constant envelope modulation and having an antenna connector 2017-05-28 2017-09-24

Any manufacturer of product falling under one or more of these standards has only one option and that it to use a Notified Body to certify their product. There is already concern that the limited number of Notified Bodies certified under the Radio Equipment Directive will be in high demand and as such delays in certification may become inevitable.

Manufacturers are advised to keep themselves up to date with those standards which become adopted prior to the 13th of June 2017 and which they have time to fully implement, or to appoint a notified body if there is no harmonised standard or the standard is likely to be adopted simply too late for self certification prior to product launch.

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Radio Equipment and Electromagnetic Compatibility Directives

The EMC (Electro-Magnetic Compatibility) Directive 2004/108/EC is one of a number of CE Marking Directives that have been recast to bring them into line with EU Decision No. 768/2008/EU New Legislative Framework (NLF) introduced in 2008. The recast Electromagnetic Conformity (EMC) 2014/30/EU directive came into force on the 18th April 2014. The old directive  2004/108/EC was repealed on the 20th of April 2016 since which time manufacturers can no longer continue to place products on the market unless they comply with the new Directive.

The Radio Equipment Directive (RED) 2014/53/EU came into force on the 13th of June 2016, with a transition period of one year until the 13th of June 2017. During this transition period manufacturers of Radio Equipment may decide to use the R&TTE Directive 1999/5/EC or Radio Equipment Directive. After the 13th of June 2017 no radio equipment may be placed on the market unless it complies with the Radio Equipment Directive.

Recall Cases Analysis of Apparel and Footwear — September 2016

Hoverboards problems and solutions

Just before Christmas the problems with hoverboards hit the headlines. CEM International as a notified body for the Toy Directive, Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), and Machinery Directive were perfectly placed to be able to determine the cause of the problems.

Centre Testing International, our test lab had it been used would have found the boards seriously lacking and in breach of the essential safety requirements of the LVD. The problems could have been ironed out as early as the design phase.

What a pity the manufacturers did not even make use of CEM International before placing their product on the market as the problems would again have been flagged (and certification refused)to them before the product got to market.

Had we been involved either with testing then there would have been no house fire in America or Australia, no exploding boards in the USA, and no other issues. The result could have lead to the hoverboard being the hottest item last Christmas for all the right reasons.

As it is the fiasco left a nasty taste in many peoples mouths, CEM were informed by one individual who had bought a large quantity of hoverboards from China and due to contract was unable to return them even though they did not meet regulations, and reworking the product in the UK would have proved cost prohibitive we believe they were probably destroyed.

This sorry tale should remind everyone of the old adage “caveat emptor” (let the buyer beware) as the purchaser of product for sale anywhere in the world you need to be very sure that the goods meet all of the standards in their intended market.

A cautionary tale and one where use of our test lab or notified body would have saved money, time, inconvenience, expensive law suits, insurance claims, increased insurance premiums, and the hoverboard could we have been the success it should have been.

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EU Referendum Impact on CEM as a Notified Body

The UK government may be in tatters, our prime minister has resigned, Mr Corbyn has lost 20 of his 31 strong shadow cabinet and to rub salt in there have been calls for his resignation,  Despite the upheaval within UK government it is very much business as usual at CEM.

The UK is to remain part of the EU for two years following our application to leave and in the meantime all EU regulations pertaining to product approvals must remain in place.

UKAS has stated:

“Following the recent referendum on EU membership, the situation currently remains the same and there is no change to UKAS’ status, nor the status of certificates issued by UKAS accredited organisations….our current expectation is that very little will change from an accreditation point of view.”

The EU directives which are the basis of product approval have been incorporated into UK law. The underlying standards are considered proof that products meet the requirements of the directives. The UK continues to participate in the development of standards.

BSI statement:

“As the UK’s National Standards Body, BSI will continue to develop and publish British Standards. Our membership of the two international standardization organizations, ISO and IEC, will not be affected where we will continue to play an influential leadership role.

There are three European Standardization Organizations – CEN, CENELEC and ETSI. Our full membership of CEN and CENELEC will continue while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working with the UK Government (such as Department of Business, Innovation and Skills) and other parties as appropriate such as European political institutions and European Standardization Organizations regarding its role in the development of the European standardization system. We expect BSI’s membership of ETSI will be unaffected”

Therefore during the next two years it is likely that nothing will change within Europe whilst the UK will be forced to remain part of the EU. It is our opinion that the UK will not try to create standards which differ from those adopted by the EU member states unless there becomes an issue which adversely affects the UK. Many countries adopt EU standards  without being a part of the EU it is for these reasons we believe that for the foreseeable future there is unlikely to be any change.

CEM as a notified body are legally obliged to inform our customers of any changes to standards so you do not need to be proactive, we will inform you in good time of any pending changes.

We are closely monitoring the situation as it evolves, at this time we do not foresee any dramatic changes in UK product regulations.

The Rapid Alert System for Non-Food Products (RAPEX) – Hoverboards recalled and destroyed

Notification Reference: A12/1617/15

Risk level Serious risk
Product user Consumer
Notifying country United Kingdom
Product category Hobby/sports equipment
Product Self-balancing scooter
Brand Misuta
Name Misuta Sport
Type/number of

model

Scooter: Misuta GT. Charger: HK-42-2000.
Batch

number/Barcode

Unknown
OECD Portal

Category

71000000 – Sports Equipment
Description Self-balancing, two-wheel scooter (“hoverboard”) supplied with a charger and a mains supply cord

with a three-pin plug. Packaged in a cardboard box.

Country of origin China
Counterfeit
Risk type Fire / Electric shock
 

Risk description

The battery charger has no cut-off switch on the charging circuit which means that the battery could

overheat when it is fully charged and potentially cause a fire. Live parts of the output connector are

accessible. The product does not comply with the requirements of the Low Voltage Directive and the

relevant European standards EN 60950, EN 62133 and EN 60320.

Measures adopted

by notifying country

Compulsory measures: Destruction of the product
Products were

found and measures

were taken also in

 

Images

hoverboard