Standards and Specifications

Standards are defined as documents which describe the characteristics and functions of devices. Specifications provide details relating to material selection, form of construction, dimensions, marking and packing, etc. The degree of dimensional details is restricted to those required to match up with other components in a composite assembly, together with achievement of consistency and sizing within production batches and as between different manufacturers. The practice in this area has been to specify preferred dimensions to cover a range of sizes and the intervals between preferred levels. Broadly, these aspects aim at assisting in the choice of the most suitable item for a given situation and also to restrict unnecessary duplication and proliferation of sizes by different manufacturers. Standards and specifications will generally protect the interest of the consumer as well as the manufacturer and supplier. The consumer will have the confidence in the functional performance and safety of the device, the manufacturer will have the benefits and possibility of international marketing, together with the protection that an international standard can afford. These matters are further considered under two separate headings: Orthopaedic implants and Prosthetic and orthotic devices.