The EN ISO 16061 standard, developed by the International Standards Organization (ISO), describes the features and test methods for the safety and performance of instruments used with inactive surgical implants. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 16061 Instruments used with inactive surgical implants - General characteristics.
This standard specifies the general requirements for medical equipment used with inactive surgical implants. These requirements apply to newly manufactured or refurbished equipment. This international standard also applies to instruments connected to power-driven systems, but not to the power-driven systems themselves. Regarding safety, this standard provides requirements for intended performance, design specifications, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. However, this standard does not cover instruments related to dental implants.
The structure of the EN ISO 16061 standard is determined as follows:
Standards that are referred to as normative in the implementation of this standard and indispensable for its implementation are: ISO 8601, ISO 11135, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1, ISO 11607-2, ISO 14155, ISO 17664 ISO 17665-1 and ISO 80000-1.
Our organization also provides safety and performance testing services for instruments used with EN ISO 16061 non-active surgical implants within the scope of laboratory services.
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