British Standards Institution

Source:: ISO
Committee:: CH/212 - IVDs
Categories:: In vitro diagnostic test systems

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:

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

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

04/07/2024

3. Public Comments (Complete)

4. Comment Resolution (Complete)

Comment Resolution start date:

27/08/2024

5. Approval

Approval start date:

6. Publication

Publication start date:

04/12/2024

Learn more about the standards development process

Standards Development

PD ISO/TS 16766 Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

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