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Tag: CE testing

EU – RED Update

Posted on February 3rd 2020

The (RED) 2014/53/EU becomes mandatory as of June 13, 2017. Products placed on the EU market as of that date must comply with the RED; the R&TTE Directive will no longer be valid.

When a manufacturer assesses compliance of radio equipment under the essential requirements of RED Articles 3.2 and 3.3 and harmonized standards are (1) applied only in part, (2) available but not applied, or (3) are not available, then it is mandatory for that manufacturer to use a Notified Body (NB), per RED Article 17.4.

The standard will not be ready in time to be placed in the Official Journal of the European Union (OJEU) as a harmonized standard for the RED, therefore manufacturers will be required to use a NB for the type of equipment falling under this standard, including Broadband Radio Access Networks (BRAN) and 5 GHz high performance RLANs, until the document is finalized and becomes a harmonized standard, which may create a high demand for NB involvement in the meantime.

 
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 
Published in MultiPoint Blog
On September 30, 2015, the EU Electronic Communications Committee issued a new version of relating to the Use of Short Range Devices (SRDs) with updated recommendations providing the following:
  • Implementation status within the EU/EEA-EFTA countries (Appendix 1)
  • Implementation status within the CEPT countries not being EU/EEA-EFTA (Appendix 1)
  • National restrictions within the CEPT countries (Appendix 3)
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 
Published in MultiPoint Blog

EU – RTTECA/REDCA Bi Annual Meeting

Posted on February 3rd 2020
During June 1-2, 2015, the 30th R&TTECA meeting took place in Göteborg, Sweden and was hosted by SP -  Sveriges Tekniska Forskningsinstitut. The meeting was attended by more than 60 members including many from non-EU countries.  The main issues discussed are as follows:
  1. Situation on transition of equipment in 2016 to and from the Radio Equipment Directive, EMC Directive and Low Voltage Directive;
  2. Consequences of the application of the RED and new EMCD and new LVD
  3. Results of and input from R&TTECA in the EU Commissions working group developing the Guide for the new Radio Equipment Directive – RED;
  4. Report of the ongoing Market surveillance activities in the EU;
  5. Feedback from the recent TCBC Workshop in the USA;
  6. Update of the requirements for radio equipment entering the market in Japan;
  7. Discussion of a large number of technical issues and issues related to the operation of the R&TTE Directive or new RED such as, amongst others:
  • ”Making available” and products intended for own use
  • Question on the Declaration of Conformity in the user manual  
  • Health requirements not being assessed
  • Fixed or Portable use definition
  • Validity of NB opinion
  • AC in standards
  • 9.5 GHz Slope Stability Radar Standards
  • Indoor versus Outdoor use
  • Treatment of Non-linear Junction Detectors  
  • CE marking in "transport" (not sales packaging) packaging
  • Translate instructions and safety instruction in country languages
  • Using old versions of standards
  • Definition of TX Gap for FHSS in ETSI EN 300328 V1.8.1
  • Bluetooth Worst Case Test
  • E compliance
  • Choice of standards for the safety of R&TTED products
The next meeting will be held in November 2015 in Nice, in combination with an ETSI Workshop related to all new standards being developed currently for the RED and new EMCD.
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 
Published in MultiPoint Blog

During April 2015, the European Commission published the following updated list of standards in the Official Journal of the European Union to be used for assessing compliance. 

Please contact Rhein Tech if you have additional questions or testing requirements。 703。689。0368

Published in MultiPoint Blog
During March 2015, the R&TTE Compliance Association issued . The guidance is intended to help Notified Bodies confirm the integrity and validity of test reports submitted by agents, manufacturers or test laboratories with which the Notified Body does not have consistent experience. 
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 

The European Commission will be adding four additional substances to the EU RoHS Directive (2011/65/EU)。 Four phthalate substances will be added to the RoHS substance restrictions。 Phthalates are primarily used as plasticizers in plastics, particularly in PVC plastic which is commonly used for wires and cables but can also be found on some electronic components or other plastic parts。 The restrictions take effect beginning on July 22, 2019 and most products will need to comply including medical devices, by July 22, 2021。 

Published in MultiPoint Blog

EU – EN 300 328 V1.7.1 Withdrawn

Posted on February 3rd 2020
On January 1, 2015, EN 300 328 V1.8.1 will replace EN 300 328 V1.7.1 as a harmonized standard. Manufacturers must fully comply with EN 300 328 V1.8.8 and will no longer be able to test using a combination of EN 300 328 V1.7.1 and the Adaptivity and Receiver Blocking clause from v1.8.1.   Because the standard has been extensively overhauled, there are numerous differences between EN300 328 V1.7.1 and EN300 328 V1.8.1 with changes to both the test requirements and methodology.  
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 
Published in MultiPoint Blog
The European Union Association of Notified Bodies (EUANB) issued , to provide guidance on the way to demonstrate compliance to EMF requirements under article 3.1a of the R&TTE 1999/5/EC Directive.   To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ hfytxx.com or call us at 703.689. 0368.
 
Published in MultiPoint Blog

Recently in August 2014, Brazil's medical device market regulator, ANVISA, announced plans to implement a system for electronic submission of registration applications based on guidelines from the International Medical Device Regulators Forum (IMDRF).  The IMDRF system, known as Regulated Product Submission (RPS), is being created to harmonise premarket device submissions and approvals across different national markets. 

To find out more, please contact Rhein Tech Laboratories, Inc. at sales@rheintech. com or call us at 703.689.0369

Published in MultiPoint Blog

In April 2014, the European Union Association of Notified Bodies (EUANB) issued . The EUANB has noticed that test reports do not always contain test results and often times report only a "pass" or "fail" statement with no actual test results. The EUANB agreed that test reports must contain the actual test results, not just a pass or fail statement and full test data is an essential part of the test report which allows manufacturer to sign their Declaration of Conformity.


To find out more, please contact Rhein Tech Laboratories, Inc. at or call us at 703.689.0368

Published in MultiPoint Blog
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