Base: | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 |
Modification: |
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Welcome to gainspeed Ltd,
CE Marking Specialists
A South Wales based Product Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations
Specialists in EMC and Low Voltage
(Safety) Directives
We specialise in European and Worldwide approvals.
Flexible, Professional, and Affordable Service
We are a small organisation employing only
highly experienced associates.
Base: | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 |
Modification: |
|
Short name: | In vitro diagnostic medical devices |
Base: | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331 of 7 December 1998 |
Must be applied by 22 May 2018!
This is the probably the last update to this standard as it will be replaced by EN 55035
One of the main changes is the option of using a 4 % step size for continuous conducted immunity test now deleted!
BS EN 55032:2015, “Electromagnetic compatibility of multimedia equipment – Emission Requirements” is now available from BSI.
The date of withdrawal, (of conflicting standards), is shown as 5th May 2018.
This standard will replace BS EN 55032:2012, and partially replace BS EN 50561-1:2013