British Standards Institution

Source:: ISO
Committee:: CH/150/2 - Cardiovascular implants
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Implants for surgery, prosthetics and orthotics

Scope

The scope of this PAS is to specify standardized methods for the measurement of inflow internal orifice diameters and prosthesis minimum internal diameter of surgically implanted heart valve substitutes.

Purpose

ISO 5840-2:2021 specifies that outer container labelling for surgical valve implants shall include in diagrammatic and/or tabular form items such as, among others, inflow internal orifice diameter and prosthesis minimum internal diameter (see section 6.3.3 Packaging, labelling, and sterilization of ISO 5840-2:2021). However, no standardized method is available or specified to reproducibly measure these geometric parameters, particularly for bioprosthetic heart valve substitutes with flexible leaflets.

Comment on proposal

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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? *

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

Standard timeline

1. Proposal

Proposal start date:

04/03/2021

Proposal end date:

04/05/2021

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/PWI PAS 7020 Sizing surgically implanted heart valve substitutes

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