• There are no items in your cart

BS ISO 16054 : 2000 AMD 14017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

IMPLANTS FOR SURGERY - MINIMUM DATA SETS FOR SURGICAL IMPLANTS
Superseded date

01-07-2003

Published date

11-23-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 implantable medical device
3.2 implant event
3.3 explant event
3.4 medical facility
4 Data sets
4.1 General
4.2 Supplier data
4.3 Medical facility data
Annex A (informative) Automated device
        labelling and data capture

This standard defines minimum data sets for surgical implants to facilitate recording and international exchange of data for the purposes of implant registry and tracking to allow recall for product correction or partient follow up in the event of unforeseen device malfunction. The minimum data set also fulfills the core data requirements to allow cross referencing between extended data sets for the purposes of retrieval analysis and research. This International standard is applicable to manufacturers and distributors of medical devices intended for permanent implant, i.e. means more than 30 days and to those hospitals and other medical facilities which carry out implant procedures.

Committee
CH/49
DevelopmentNote
Renumbered and superseded by BS EN ISO 16054. (01/2003)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
ISO 16054:2000 Identical

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 8402:1994 Quality management and quality assurance — Vocabulary

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.