Non-active surgical implants - Implants for osteosynthesis - Particular requirements
|Publication Date:||1 March 2012|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone healing or fusion and/or to provide support or correction. When they have achieved their objective, the implants are either retrieved or left in situ. This International Standard, in addition to the requirements in ISO 14630, provides a method for addressing the fundamental principles in ISO/TR 14283 as they apply to non-active surgical implants for osteosynthesis. Annex A shows the correspondence between the clauses of this International Standard and those of ISO/TR 14283:2004. This International Standard also provides a method of demonstrating compliance with the relevant essential requirements (ERs) as outlined in general terms in Annex 1 of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, amended by Directive 2007/47/EC of 5 September 2007, as they apply to non-active surgical implants for osteosynthesis. It might also assist manufacturers to comply with the requirements of other regulatory bodies. Alternative methods of demonstrating compliance might be acceptable, in particular with respect to implants which have demonstrated satisfactory long-term clinical performance. There are three levels of standard concerned with non-active surgical implants and related instrumentation. For the implants themselves, there are the following levels, with level 1 being the highest: ? level 1: general requirements for non-active surgical implants; ? level 2: particular requirements for families of non-active surgical implants; ? level 3: specific requirements for types of non-active surgical implants. Level 1 standards contain requirements that apply to all non-active surgical implants. They also indicate that additional requirements are given in the level 2 and level 3 standards. Level 2 standards, such as this International Standard, contain requirements that apply to a more restricted set or family of non-active surgical implants. This International Standard is a Level 2 standard that lays down particular requirements for non-active surgical implants for osteosynthesis that are in addition to those general requirements stated in ISO 14630 for non-active surgical implants. It is to be applied in conjunction with ISO 14630. Level 3 standards, such as those listed in the annexes, apply to specific types of implant within a family of non-active surgical implants, in this case particular types of non-active surgical implant for osteosynthesis. To address all requirements for a specific implant, it is advisable that the standard of the lowest available level be consulted first.