Skip to main content

ISO 16061:2015

Withdrawn Date published:

Warning: Withdrawn Standard. This document has been replaced by:

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.

Get this standard Prices exclude GST
PDF ( Single user document)
$91.24 NZD
HardCopy
$91.24 NZD
Networkable PDF
Price varies
Redline PDF
$91.24 NZD
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 19

Previous versions

Keep me up-to-date

Sign up to receive updates when there are changes to this standard

Related Information

Similar Standards

  • AS/NZS 2817:1997

    Implants for surgery - Care and handling of orthopaedic implants

  • AS/NZS 4261:1994

    Reusable containers for the collection of sharp items used in human and animal medical applications

  • AS/NZS 4261:1994 A1

    Reusable containers for the collection of sharp items used in human and animal medical applications: Amendment 1

  • AS/NZS 60601.2.46:2022

    Medical electrical equipment, Part 2.46: Particular requirements for the basic safety and essential performance of operating tables

Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 19

Previous versions

ISO 16061:2015

Get this standard Prices exclude GST
PDF ( Single user document)
$91.24 NZD
HardCopy
$91.24 NZD
Networkable PDF
Price varies
Redline PDF
$91.24 NZD

Request to add this standard to your subscription

ISO 16061:2015

Price varies
Online library subscription

Click "Send request for subscription" to request for your Account Administrator to add this standard to your subscripiton.

Comment

Cancel