BS EN ISO 16061:2015 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.

This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.

This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.


Cross References:
ISO 8601
ISO 11135
ISO 11137-1
ISO 11137-2
ISO 11137-3
ISO 11607-1
ISO 11607-2
ISO 14155
ISO 14971
ISO 17664
ISO 17665-1
ISO 80000-1
ISO 4957
ISO 7000-DB:2012
ISO 7151
ISO 7153-1:1991
ISO 7153
ISO 7740
ISO 8319-2
ISO 10993-1
ISO 10993-7
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-18
ISO/TS 10993-19
ISO 11138-1
ISO 11138-2
ISO 11138-3
ISO 11140-1
ISO 11140-3
ISO 11140-4
ISO 11140-5
ISO 11737-1
ISO 11737-2
ISO 13408-1
ISO 13485
ISO 14161
ISO 14937
ISO/TR 14969
ISO 15223-1
ISO 15882
ISO 15883-1
ISO 15883-2
ISO 15883-3
ISO 18472
IEC 60068-2-27
IEC 60068-2-31
IEC 60068-2-47
ISO 5832-1
ISO 5832-9
ISO 5832-4
ISO 5832-5
ISO 5832-6
ISO 5832-7
ISO 5832-8
ISO 5832-12
ISO 5832-2
ISO 5832-3
ISO 5832-11
EN 2100
EN 2127
EN 2128
EN 2318
EN 2326
EN 2384


All current amendments available at time of purchase are included with the purchase of this document.