AS ISO 16061-2003

Table of Contents

1 -  AS ISO 16061-2003 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS-GENERAL REQUIREMENTS
4 -  PREFACE
5 -  CONTENTS
7 -  1 Scope
7 -  2 Normative references
8 -  3 Terms and definitions
8 -  3.1 associated instrument instrument
8 -  3.2 resupplied instrument
8 -  4 Intended performance
8 -  5 Design attributes
9 -  6 Selection of materials
9 -  7 Design evaluation
9 -  7.1 General
9 -  7.2 Pre-clinical evaluation
9 -  7.3 Clinical evaluation
9 -  8 Manufacture
10 -  9 Sterilization
10 -  9.1 Products supplied sterile
10 -  9.2 Products provided non-sterile
10 -  10 Packaging
10 -  10.1 Protection from damage in storage and transport
10 -  10.2 Maintenance of sterility in transit
10 -  11 Information to be supplied by the manufacturer
10 -  11.1 General
10 -  11.2 Instruments with measuring function
11 -  11.3 Restrictions in combinations
11 -  11.4 Marking on instruments
11 -  11.5 Instructions for use
11 -  11.6 Instruments intended for single use
12 -  Annex A - Examples of typical instrument applications, together with materials found acceptable for instrument...
12 -  A.1 Invasive applications
13 -  A.2 Non-invasive applications
13 -  A.3 Materials for invasive applications
18 -  A.4 Materials for non-invasive applications
24 -  Bibliography
24 -  List of International Standards
24 -  List of general European and International Standards
25 -  List of European Standards on non-active surgical implants

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Pages
ISBN
Committee	HE-012
Supersedes	DR 03122 CP