British Standards Institution

Source:: ISO
Committee:: CH/150/5 - Surgical Implants - Osteosynthesis and spinal devices
Categories:: Information management | Standardization. General rules
Comment period start date:: 01/07/2024
Comment period end date:: 22/08/2024

Comment by:

22nd Aug

Scope

This Document establishes the requirements for material, marking, finishing, care and handling, dimensions, sterilization, manufacturing, packaging, and acceptable tolerances, as well as establishes the performance requirements for metallic bone screws used as implants for osteosynthesis. This Document does not apply to implantable screws intended for the reconstruction or fixation of soft tissues, including suture anchors and interference screws. This Document does not apply to implantable screws intended for spine applications. However, the principles of this Document can be applied to these screws at user’s discretion.

Purpose

See Annex STRATEGIC PLAN ON BONE SCREW STANDARDS.

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

Standard timeline

1. Proposal

Proposal start date:

01/07/2024

Proposal end date:

22/08/2024

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/NP 25327 Orthopedic implants — Metallic bone screws — Requirements

Scope

Purpose

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