Design of medical equipment

Design management is an area that is often overlooked; this can lead to waste and missed opportunities. BSI’s standards provide generic guidance on the management of a design function, whether that function is a design company, a design department within an organization, or a designer’s own project.

These standards include the BS 7000 and BS 7373 series, applicable to a variety of sectors for almost all products. BS 7000 and BS 7373 can be used by the medical product sector to develop their own design management standards.

The BS 7000 series of standards addresses the issues surrounding design management from initial outset of the design of a product through to the end of its lifecycle and when it becomes obsolescent.

In addition, BS 8888 provides the definitive set of requirements for technical product specifications. BS 8888 (and the associated BS ISOs on product specification) is a suite of standards on how a product, or part of a product, is specified for manufacture.

BS 8888:2008
Technical product specification. Specification

BS EN ISO 14971:2009
Medical devices. Application of risk management to medical devices

BS EN 55011:2009
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement

BS EN 60601-1:2006
Medical electrical equipment, General requirements for basic safety and essential performance

BS 8887-1:2006
Design for manufacture, assembly, disassembly and end-of-life processing (MADE). General concepts, process and requirements

BS 7000-6:2005
Design management systems. Managing inclusive design

BS EN 980:2008
Symbols for use in the labelling of medical devices

Graphical symbols for use in the labelling of medical devices CD-ROM

BS 8432:2005
Spinal orthoses. Guide to design

Visit the design and product specification page for more standards

Return to the healthcare and medical devices homepage