Foreword

This Part of BS 7254 has been prepared under the direction of the Health Care Standards Policy Committee and supersedes BS 3531 : Part 17 : 1985 which is withdrawn. It takes cognizance of ISO 8828 : 1988 'Implants for surgery — Guidance on care and handling of orthopaedic implants' prepared by Technical Committee 150 'Implants for surgery' of the International Organization for Standardization (ISO).

Requirements for orthopaedic implants (then termed 'surgical implants') were first published in 1962 as BS 3531. In 1968 a part revision of BS 3531 : 1962 was issued as BS 3531 : Part 1, which dealt with surgical implants made of all materials. In 1980 the first four Parts of a multi-part version of BS 3531 were published.

A further 19 Parts of BS 3531 were subsequently published, Part 17 : 1985 giving recommendations for the care and handling of orthopaedic implants. In view of the increase in the number of Parts, and with a view to facilitating the implementation of published or forthcoming ISO implant standards, the British Standard relating to implants has been restructured. Accordingly, the number BS 3531 is reserved for standards on implants for osteosynthesis, BS 7251 covers joint prostheses, BS 7252 covers metallic materials for surgical implants, BS 7253 covers non-metallic materials for surgical implants and BS 7254 covers orthopaedic implants, i.e. aspects common to both osteosynthesis and joint replacement.

This edition of BS 7254 : Part 3 introduces editorial changes to reflect this restructuring, and up-dates cross-references but otherwise makes no changes to the recommendations for care and handling of orthopaedic implants first published as BS 3531 : Part 17 : 1985. It does not reflect a full review or revision of the standard which will be undertaken in due course.

These recommendations are concerned with the care and handling of orthopaedic implants after delivery to the purchaser to help ensure that implants remain free of contamination or damage prior to insertion into the patient. Recommendations are given for the procedures for receiving implants, for their storage, transport, handling, cleansing and sterilization, and the precautions necessary in preparing them for use are outlined. The recommendations are addressed to all personnel who are involved in receiving and handling implants. It is imperative that personnel should be familiar with these recommended procedures, in order to minimize the occurrence of damage to implants.

It is recognized that differences exist between hospitals in the allocation of particular tasks to personnel, in the relative geographical positions of the various departments involved in handling implants and in the distribution of particular functions among these departments. For these reasons the recommendations do not presuppose a specific organizational regimen; rather they are based on the generalized outline of the typical routes along which an implant may pass (see figure 1), accepting that there will inevitably be differences in detail.

Some of the recommendations given in this Part of BS 7254 relate to the marking borne by the implant and the information supplied on the packaging or a package insert. However, the-details of the information available to the purchaser in this way will reflect the diversity of origin and manufacturers' practices. Many implants are manufactured in accordance with BS 3531, BS 7251 or BS 7253 and details of the devices and their packaging and marking may be found in the appropriate Parts.

Once implantation has been completed, an implant should never be reused after removal.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

Amendments/corrigenda issued since publication

Date	Text affected

BS 7254-3:1990

Orthopaedic implants - Recommendations for care and handling

Current

Published:

31 Aug 1990