Skip to main content

ISO 16054:2019

Current Date published:

Implants for surgery — Minimum data sets for surgical implants

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.

This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.

It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

Get this standard Prices exclude GST
PDF ( Single user document)
$59.78 NZD
HardCopy
$59.78 NZD
Networkable PDF
Price varies
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 6

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

  • BS 2574-1:1991

    Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses

  • BS 2574-2:1994

    Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses

  • BS 3531-11:1991

    Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs

Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 6

Previous versions

ISO 16054:2019

Get this standard Prices exclude GST
PDF ( Single user document)
$59.78 NZD
HardCopy
$59.78 NZD
Networkable PDF
Price varies

Request to add this standard to your subscription

ISO 16054:2019

Price varies
Online library subscription

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

Cancel