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Homepage>CSN Standards>85 HEALTH SERVICE>8529 Surgical implants>CSN EN ISO 16061 - Instrumentation for use in association with non-active surgical implants - General requirements
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FREE SHIPPINGReleased: 2015
CSN EN ISO 16061 - Instrumentation for use in association with non-active surgical implants - General requirements

CSN EN ISO 16061

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

CURRENCY
LANGUAGE
English
Category:852940
Released:2015
Number of Standard:CSN EN ISO 16061
DESCRIPTION

EN ISO 16061


EN ISO 16061 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.

Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.
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