ISO 16061:2000被替代
Instrumentation for use in association with non-active surgical implants - General requirements
出版：International Organization for Standardization
專家解讀視頻
This International Standard 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 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, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.NOTE References to standards for non-active surgical implants are listed in the Bibliography.
KS P ISO 16061:2008 - Identical
KS P ISO 16061:2014 - Identical
NEN ISO 16061:2000 - Identical
NBR ISO 16061:2002 - Identical
AS ISO 16061-2003 - Identical
