Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003Giving you support and advice in the implementation of a quality management system for medical devices This Technical Report provides guidance for the application of BS EN ISO 13485. It can be used to better understand the requirements of BS EN ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting best practice guidelines. The guidance is applicable to the design, development, production, installation and

the tests included in this document are in excess of the existing IMO requirements

or from which test specimens are cut

industry or sector

2 Automatic welding filters and automatic welding filters with manual scale number setting

It specifies how the image is to be acquired (including lighting

It doesn’t cover:

or components thereof

detect the spontaneous heart activity and stimulate appropriately the atrium and/or the ventricle

BS EN 12697-32 is used to establish a refusal density for a bituminous mixture

and dimensions and tolerances

to help you select the appropriate balancing approach for your application

Risk management consultants