IS 14227 : 1995/ISO 8615 : 1991 Implants for surgery - Fixation devices for use in the ends of the femur in adults

National Foreword

This Indian Standard which is identical with ISO 8615 : 1991`Implants for Surgery - Fixation Devices for use in the ends of thefemur in adults', issued by the International Organization forStandardization (ISO), was adopted by the Bureau of IndianStandards on the recommendation of the Orthopedic Instruments andAccessories Sectional Committee and approval of the MedicalEquipment and Hospital Planning Division Council.

Fixation devices for use in the upper and the lower ends of thefemur may be made in a variety of configurations, according to thedesign of the originator or the individual manufacturer. However,certain dimensions are critical and may not be exceeded withoutrisk of damage to the bone when the device is inserted. Other thanspecifying this limited number of features, the main object of thisstandard is to ensure uniformity in designating and describing thesize of the device in order that devices of different origin but ofthe same nominal size will not differ significantly in theircritical dimensions. It is required that these dimensions be statedon the packaging and marked on the device: it is also required thatthe packaging carry other information useful to the surgeon, suchas, details of instruments and ancillary devices necessary at theimplantation of the device.