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ISO 16061:2008

Instrumentation for use in association with non-active surgical implants — General requirements
25 nën 2008
95.99 Withdrawal of Standard   11 maj 2015

General information

95.99     11 maj 2015

ISO

ISO/TC 150

International Standard

11.040.40     11.040.99  

anglisht   frëngjisht  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 16061:2000

NOW

WITHDRAWN
ISO 16061:2008
95.99 Withdrawal of Standard
11 maj 2015

CORRIGENDA / AMENDMENTS

ABANDON
ISO 16061:2008/NP Amd 1

REVISED BY

WITHDRAWN
ISO 16061:2015