ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:

ISO 13485:2015 is due to be published early 2016.

The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.

Some of the key changes include:

* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:

* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you

* Learn more about the ISO 13485 revision

EN 61000-3-3:2013 (Flicker) replaces EN 61000-3-3:2008 on 18 June 2016!

This means EVERY AC operated product under the scope of EN 61000-3-3:2008 must be re-assessed, test report modified if necessary or technical justification prepared for the Technical File if no retest is done and a new EU DoC updated to reflect this change!
Most older test equipment used to measure flicker would not have been rated with EN61000-4-15:2011 (new method called in EN 61000-3-3:2013) as such it may be necessary to retest to the new standard or make a technical justification.
Its recommended that you check with the test house that originally tested your equipment, it may also say in your original test report.
If required we can now retest to the latest standard at our facility for you.

Contact us.

 

 

What is power line communication?

A common example of this is the home power-line communication adapters commonly used to transfer broadband from one adapter plug to another anywhere in your home. It doesn’t suffer the problems associated with signal loss from walls and obstructions like WIFI. This makes it a great way to get internet from a source connection downstairs to an office upstairs, which normally would be to far away for WIFI signals to reach.

Its also popular in offices, apartments and hotels with some networks crossing across the threshold of properties via distribution networks and premises wiring. Typically transformers prevent propagating the signal, which requires multiple technologies to form very large networks.

Various data rates and frequencies are used in different situations.

 

What is BS EN 50561-3:2016 for?

In-home Power line communication apparatus (PLC) use the mains-electricity wiring in the home for communication by injecting differential-mode (DM) signals. However these signals have the potential to cause interference to the operation of radio or telecommunication apparatus.

To control this situation both radiated-emissions and conducted-emissions tests are now specified, and both are necessary as they control different things. EN 50561-3 applies to equipment that uses frequencies including those above 30 MHz in order to communicate. Procedures are given for the measurement of signals generated by the equipment and limits are specified within the frequency range 9 kHz to 400 GHz. No measurement is required at frequencies where no limits are specified.

The radiated emission requirements in this standard are not intended to be applicable to the intentional transmissions from a radio-transmitter as defined by the ITU, nor to any spurious emissions related to these intentional transmissions.

 

When is BS EN 50561-3:2016 coming out?

latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement
(dop) 2016-11-23

latest date by which the national standards conflicting with this document have to be withdrawn
(dow) 2018-11-23

 

For more information contact us