BS PD CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

BSI Group, 03/21/2018

Publisher: BS

File Format: PDF

$189.00$378.46


Published:21/03/2018

Pages:88

File Size:1 file , 940 KB

Note:This product is unavailable in Ukraine, Russia, Belarus

BS PD CEN/TR 17223:2018 provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.


Cross References:
ISO 13485:2016
BS EN ISO 13485:2016


All current amendments available at time of purchase are included with the purchase of this document.

More BS standard pdf

BS 5045-1:1982

BS 5045-1:1982

Transportable gas containers-Specification for seamless steel gas containers above 0.5 litre water capacity

$125.00 $251.46

BS 4359-2:1982

BS 4359-2:1982

Determination of the specific surface area of powders-Recommended air permeability methods

$125.00 $251.46

BS 6128-9:1982

BS 6128-9:1982

Industrial laminated rods and tubes based on thermosetting resins-Specification for round moulded tubes

$125.00 $251.46

BS 4533-102-102.8:1982

BS 4533-102-102.8:1982

Luminaires. Particular requirements-Specification for handlamps

$125.00 $251.46