British Standards Institution

Source:: ISO
Committee:: CH/150/1 - Materials for surgical implants
Categories:: Implants for surgery, prosthetics and orthotics
Comment period start date:: 19/11/2024
Comment period end date:: 12/01/2025
Number of comments:: 0

Comment by:

12th Jan

Scope

This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants.

This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.

Read draft and comment

Comment on proposal

Required form fields are indicated by an asterisk (*) character.

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: *

Discard

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

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

17/09/2024

3. Public Comments

Public Comments start date:

19/11/2024

Public Comments end date:

12/01/2025

Learn more about the standards development process

Standards Development

BS ISO 5834-2 ISO 5834-2 Implants for surgery. Ultra-high-molecular-weight polyethylene. Part 2: Moulded forms

Scope

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error