Tagasi

Vabandust – see toode pole enam saadaval

ISO 16061:2008

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

Üldinfo
Kehtetu alates 11.05.2015
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
11.05.2015
Põhitekst
Põhitekst
ISO 16061:2008
Põhitekst
ISO 16061:2000
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.
*
*
*
PDF
133,30 € koos KM-ga
Paber
133,30 € koos KM-ga
Standardi monitooring