ISO 16061:2015
Instrumentation for use in association with non-active surgical implants — General requirements
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.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
8 Manufacture
9 Sterilization
9.1 Products supplied sterile
9.2 Products provided non-sterile
10 Packaging
10.1 Protection from damage in storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
11.1 General
11.2 Labelling
11.3 Instructions for use
11.4 Instruments with measuring function
11.5 Restrictions in combinations
11.6 Marking on instruments
11.7 Instruments intended for single use
Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
8 Manufacture
9 Sterilization
9.1 Products supplied sterile
9.2 Products provided non-sterile
10 Packaging
10.1 Protection from damage in storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
11.1 General
11.2 Labelling
11.3 Instructions for use
11.4 Instruments with measuring function
11.5 Restrictions in combinations
11.6 Marking on instruments
11.7 Instruments intended for single use
Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture
Bibliography