BS EN ISO 16061:2015 pdf free.Instrumentation for use in association with non-active surgical implants — General requirements.
BS EN ISO 16061 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
BS EN ISO 16061 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
6 Selection of materials
Materials for the manufacture of instruments shall be selected with regard to the properties required for the intended purpose, taking into account the effects of manufacture, handling, sterilization, and storage, as well as any treatment (chemical, electro-chemical, thermal, mechanical, etc.) applied to the surface or a part of the surface of the instrument in order to modify its properties. Possible reactions of instrument materials with human tissues and body fluids shall be considered (see Clause 7).
The suitability of a given material for a particular application shall be demonstrated by either
a) documented assessment in accordance with ISO 10993-1, or
b) selection from the materials found suitable by proven clinical use in similar applications.
NOTE Annex A lists some of the materials that have been found acceptable in certain applications.
7.1 General
Instruments shall be evaluated in association with the implant they are designed for, in order to demonstrate that the intended performance is achieved (see Clause 4).
Safety shall be demonstrated by pre-clinical evaluation and by carrying out a risk analysis in accordance with ISO 14971.
7.2 Pre-clinical evaluation
If pre-clinical testing of instruments is required, the testing shall simulate conditions of intended use.
7.3 Clinical evaluation
If a clinical evaluation is required, it shall be based on the following:
a) critical evaluation of the relevant scientific and clinical literature relating to the safety, performance,
design characteristics, and intended use of the instrument or demonstrably similar instruments; or
b)critical evaluation of the results of all clinical investigations conducted using the associated implant
under the intended conditions of use: or
c) combination of the clinical data provided in a)and b)above
Where a clinical investigation is carried out, it shall be managed in accordance with ISO 14155.BS EN ISO 16061:2015 pdf free download.