Instrumentation for use in association with non-active surgical implants – General requirements (ISO 16061:2008, Corrected version 2009-03-15)
Abstract
ISO 16061:2008 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.
ISO 16061:2008 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, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
DIN EN ISO 16061:2010-01 (E)
Instrumentation for use in association with non-active surgical implants – General
requirements (ISO 160 61:2008, Corrected version 2009-03-15)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Intended performance ……………………………………………………………………………………………………..5
5 Design attributes …………………………………………………………………………………………………………….6
6 Selection of materials ……………………………………………………………………………………………………..6
7 Design evaluation ……………………………………………………………………………………………………………6
7.1 General …………………………………………………………………………………………………………………………..6
7.2 Pre-clinical evaluation …………………………………………………………………………………………………….7
7.3 Clinical evaluation …………………………………………………………………………………………………………..7
8 Manufacture ……………………………………………………………………………………………………………………7
9 Sterilization …………………………………………………………………………………………………………………….7
9.1 Products supplied sterile ………………………………………………………………………………………………..7
9.2 Products provided non-sterile …………………………………………………………………………………………7
10 Packaging ………………………………………………………………………………………………………………………7
10.1 Protection from damage in storage and transport ……………………………………………………………7
10.2 Maintenance of sterility in transit …………………………………………………………………………………….8
11 Information to be supplied by the manufacturer ………………………………………………………………8
11.1 General …………………………………………………………………………………………………………………………..8
11.2 Instruments with measuring function ………………………………………………………………………………8
11.3 Restrictions in combinations …………………………………………………………………………………………..8
11.4 Marking on instruments ………………………………………………………………………………………………….8
11.5 Instructions for use …………………………………………………………………………………………………………8
11.6 Instruments intended for single use ………………………………………………………………………………..9
Annex A (informative) Examples of typical instrument applications, together with materials found
acceptable for instrument manufacture ………………………………………………………………………….10
Bibliography …………………………………………………………………………………………………………………………………22
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….21