Category Archives: CE Marking

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

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.

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.

Machinery Directive EU Type approval of SRS Road Rail lorry ICON10

CEM have been engaged by SRS to type approve their latest addition to their already extensive line-up of road rail vehicles. The ICON10 further enhances the range with it’s enlarged boom and extended reach.

IMG_20151210_111440

CEM International sent a team to the manufacturing plant for a week to inspect the ICON10 to the Machinery Directive.

SRS provided three samples so whilst one was being inspected another ICON10 was tested to the noise requirements of EN 15746.

IMG_20151208_140959

As part on the type approval examination the vibration the operator would be exposed to whilst working on the platform was measured.

IMG_20151212_121308

Vibration testing was conducted in accordance with ISO 2631-1.

IMG_20151212_124258

The results of the vibration testing were then analysed before being incorporated into the report CEM issued to SRS.

CEM were also entrusted by SRS to carry out pre-shipping inspections on all the product awaiting release from the production facility. This inspection was carried out in accordance with EN 280 pre-shipping inspection requirements.

IMG_20151209_102125

CEM are looking forward to working with SRS again on the “Titan” project.

SRS Website

Global recall of toys and juvenile products

From the 36th week to the 37th week of 2015 a total of 16 product recall cases happened in EU, including 15 toys, and one other type of juvenile product. The country of origin in one case is unknown, the rest all came from China.
From the 1st of September 2015 to the 17th of September a total of 2 toy recall cases happened in US, all coming from China, 1 juvenile product was also recalled which originated from Morocco. A total of 3 recall cases happened in Canada 3 toys came from China, 5 other toys were recalled in Australia for these 5 the country of origin is unknown.

RECALL CASES IN THE EU (36th week to 37th week)

Recall products Reason Violated Standard & Regulation
Toy swords and shield The shield contains di-(2-ethylhexyl) phthalate (DEHP) (measured value: 0.46% by weight). This phthalate may harm the health of children, causing possible damage to the reproductive system. REACH Regulation
Plastic doll The plastic material of the doll contains di-(2-ethylhexyl) phthalate (DEHP) (measured value: 2.5% by weight). This phthalate may harm the health of children, causing possible damage to the reproductive system. REACH Regulation

 

Plastic horse and carriage A small plastic part can easily detach from the wheel of the carriage. A small child may put it in the mouth and choke on it. Toy Safety Directive and European standard EN 71-1  
Plastic toy The head and tail of the dinosaur can be easily detached, generating small parts and making the small balls inside the toy accessible. A small child could put the small parts in the mouth and choke on them. Toy Safety Directive and European standard EN 71-1
Plastic educational toy The product contains small parts (the letters) which can be easily detached. A small child could put them in the mouth and choke on them. Toy Safety Directive and European standard EN 71-1
Toy scooter Small plastic parts and small bits of the stickers can easily detach. A small child may put them in the mouth and choke on them. The locking device maintaining the steering column in position may disengage while a child is riding. This may cause the child to lose control on the scooter and fall, suffering injuries.  Toy Safety Directive and European standard EN 71-1
Rattle toy The connecting sections of the rattle can break and release the small balls inside the rattle. A small child may put them in the mouth and choke on them. Toy Safety Directive and European standard EN 71-1
 Teddy bear key-ring The product contains a small part (the metal ring) that can easily detach. A child could put it in the mouth and choke on it. Toy Safety Directive and European standard EN 71-1
Rattle toy The red balls of the rattle can easily be detached from the toy, generating small parts. A small child could put them in the mouth and choke on them. Toy Safety Directive and European standard EN 71-1
Toy gun The suction cups of the bullets can be easily detached. A child could put them in the mouth and choke on them. Toy Safety Directive and European standard EN 71-1
Toy scooter The steering tube can easily break while a child is riding, which may cause injuries in the event of a fall. Also, the broken steering tube may expose the child to sharp points causing injuries. Toy Safety Directive and European standard EN 71-1
Plastic doll set The plastic material of the dolls’ faces contains di-(2-ethylhexyl) phthalate (DEHP) (measured value: up to 31% by weight). This phthalate may harm the health of children, causing possible damage to the reproductive system. REACH Regulation
Toy scooter The front wheel is too small: it can easily get stuck in holes in the ground while a child is riding. This may cause the child to fall and suffer injuries. The handle bar ends are too small. If a child falls on them, this may cause injuries due to puncture in the abdomen. Toy Safety Directive and European standard EN 71-1
Toy scooter The front wheel is too small: it can easily get stuck in holes in the ground while a child is riding. This may cause the child to fall and suffer injuries. The handle bar ends are too small. If a child falls on them, this may cause injuries due to puncture in the abdomen. In addition, the product contains insufficient warnings and information for users. Toy Safety Directive and European standard EN 71-1
Toy scooter The front wheel is too small: it can easily get stuck in holes in the ground while a child is riding. This may cause the child to fall and suffer injuries. The handle bar ends are too small. If a child falls on them, this may cause injuries due to puncture in the abdomen. In addition, the product contains insufficient warnings and information for users. Toy Safety Directive and European standard EN 71-1
Wooden playpen When opening the gate, a child may put his/her fingers between the moving parts and trap its fingers. European standard EN 12227

 

RECALL CASES IN THE US (1st to 17th of September 2015)

Recall products Reason
Fishing Games The plastic worm at the end of the fishing pole line can separate, producing small parts that pose a choking hazard to children. Additionally, the small magnet inside the worm can liberate. Swallowing multiple magnets can result in serious internal injury.
Pink Giraffe Animal Purse The red paint on the zipper contains excessive levels of lead, violating the federal lead paint standard.
Moses Basket and Stand The Moses basket fails to meet the federal hand held infant carrier standard and the stand fails to meet the bassinet/cradle standard. The basket can slide off an inclined surface and the stand can tip, posing a fall hazard for infants.

 

RECALL CASES IN CANADA (1st to 17th of September 2015)

Recall products Reason
Summer Time Beach Toy Set The recalled toy product contains small parts that pose a choking hazard to small children.
SIMS Pro Model Stunt Scooter  The handlebars may not hold the front wheel securely in place, posing a fall hazard.

 

Janod Starfish Fishing Game The worm attached to the end of the fishing pole may break apart and expose small parts, posing a choking hazard.

 

RECALL CASES IN AUSTRALIA (1st to 17th of September 2015)

Recall products Reason
Megaphone Toy If small-parts are liberated during use, this poses a potential choking hazard to young children.
Stomping Elephant Toy If small-parts are liberated during use, this poses a potential choking hazard to young children.

 

Tiger & Hippo Toys If small-parts are liberated during use, this poses a potential choking hazard to young children.

 

Submarine Toy If small-parts are liberated during use, this poses a potential choking hazard to young children.

 

riginal Spy Pen and Notebook Lock Holographic with Spy Pen If young children gain access to the button batteries and ingest them, they may suffer internal burn injuries, which can result in serious illness and even death.

 

 

CEM Noise Directive 2006/42/EC Testing

CEM are working with a major customer to conduct noise testing on earth moving machinery & other equipment. Testing has started and will continue over the next few months weather permitting.

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One of our technical experts marking out the test area prior to setting up the microphone positions.

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Setting the blade height before starting the noise measurements.

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Attaching a microphone to the cherry picker to measure the sound pressure level at height.

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One of the 1.5 metre microphone positions.

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Everything ready for the first run.

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The machine on one of it’s runs

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Finally testing the sound pressure level of the horn. Although not part of the Noise Directive requirements it is required for the Machinery Directive.

Red Bull Equipment website