ISO 16061:2008

Instrumentation for use in association with non-active surgical implants — General requirements

Datum objavljivanja: 25. 11. 2008.

95.99 Povučen 11. 5. 2015.

Опште информације

Trenutna faza: 95.99 Effective date: 11. 5. 2015.

Inicijator: ISO

Pripada: ISO/TC 150

Vrsta: Međunarodni standard

ICS: 11.040.40 11.040.99

Jezik: engleski francuski

Kupovina

Status: Povučen

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Apstrakt

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.