AS ISO 16061:2003

$41.60

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

Published By	Publication Date	Number of Pages
AS	2003-06-30	28

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Categories: 11.040.30 - Surgical instruments and materials, AS

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Description

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.

Scope

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.

Additional information

Published Code	AS
Published By	Australia Standards
Publication Date	2003-06-30
Pages Count	28
Language	English
Edition	1
File Size	225.3 KB
ISBN	0733753507
ICS Codes	11.040.30 - Surgical instruments and materials

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AS ISO 16061:2003

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