Standard 1
Please be advised that a New Work Item Proposal has been loaded to the BSI Standards Development Portal for comment.
Any comments received will be submitted to the national committee AMT/8 – Additive Manufacturing, for consideration when deciding the UK response to the associated Standards Development Organisation.
Proposal: ISO/NP 5092 Additive manufacturing for medical — General principles — Roadmap to safe and effective additively manufactured implants.
Please visit http://standardsdevelopment.bsigroup.com/projects/9022-07296
COMMENT PERIOD END DATE: 06/08/2022
Scope
This document identifies factors that affect the safety and performance of surgical implants due to the fact these implants are manufactured additively.
This document applies to non-active implants manufactured additively, including custom-made implants and patient-specific implants.
While this document is not intended to apply to active implants, parts of the document can potentially still be used in the context of active implants.
This document identifies gaps with respect to additive manufacturing in existing implant specific standards, which might have to be revised and updated.
This document does not apply to tissue-engineered implants manufactured by AM.
NOTE 1 This document provides references to existing or currently developed relevant documents in ISO/TC 150, ISO/TC 261, ASTM F04 and ASTM F42.
NOTE 2 This document does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.
Purpose
This document is intended to provide information and guidance for designing implants and adapting additive manufacturing techniques for surgical implant applications as well as to experts drafting standards on any of these. This information and guidance are particularly intended to be useful for implant manufacturers and regulatory authorities, but could also be useful for other stakeholders.
If you have any comment or need more information, please contact Sami Ortiz at [email protected]
Standard 2
Any comments received will be submitted to the national committee AMT/4 “Industrial data and manufacturing interfaces”, for consideration when deciding the UK response to the associated Standards Development Organisation.
Proposal: ISO 24644-1 Mass customization value chain management — Part 1: Framework.
Please visit http://standardsdevelopment.bsigroup.com/projects/2022-00719
COMMENT PERIOD END DATE: 03/08/2022
Scope
This document specifies a framework for mass customization value chain management, including the framework model, functions, information flow chart of mass customization. This document does not describe interoperability at the system level and interoperability throughout the life cycle in detail.
If you have any comment or need more information, please contact Sami Ortiz at [email protected]