British Standards Institution

Source:: ISO
Committee:: CH/150/5 - Surgical Implants - Osteosynthesis and spinal devices
Categories:: Standardization. General rules | Healthcare | Medical equipment | Implants for surgery, prosthetics and orthotics

Scope

This International Standard will specify general requirements for the development and evaluation of implantable cranioplasty plates. With regard to safety, this International Standard will give requirements for design attributes, materials, manufacture, sterilization, packaging, information supplied by the manufacturer and tests to demonstrate compliance with these requirements. Additional tests will be given or referred to in level 1 and level 2 standards.

Purpose

The patient-specific implant is a regulatory challenge, because each patient will have an unique plate manufactured only for himself. There is no international standard that addresses the requirements for a given patient-specific implant, and we pretend to do so on this standard, which will provide great insight for regulation of this kind of product

Comment on proposal

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How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

08/11/2023

Proposal end date:

31/12/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/PWI 24685 Implants for surgery -- Cranioplasty plates -- Specific requirements for non-moldable plates

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