British Standards Institution

Sector: Governance & Resilience

Categories: Steels. Stainless | Implants for surgery, prosthetics and orthotics | | Surgical instruments and materials

Overview: Under the direction of CH/150, is responsible for standardization in the field of Surgical Implants - Osteosynthesis and spinal device and is responsible for the UK input to ISO/TC 150/SC 5 Osteosynthesis and spinal devices

Committee standards activity

In Progress (12)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
ISO/PWI 24685	Implants for surgery -- Cranioplasty plates -- Specific requirements for non-moldable plates Categories: Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2023-11-08	Proposal
ISO/NP 25327	Orthopedic implants — Metallic bone screws — Requirements Categories: Information management \| Standardization. General rules Proposal begins : 2024-07-01	Proposal
ISO/NP 23089-1	Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 1: Part 1: Thoracolumbar pedicle screw systems Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2023-08-30	Proposal
ISO/NP 18967-1 -	Implants for surgery — Bone anchoring systems — Part 1: Part 1: Impact, expandable and threaded suture anchors requirements Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2022-08-25	Proposal
ISO/NP 18967-1	Implants for surgery — Bone anchoring systems — Part 1: Part 1: Impact, expandable and threaded suture anchors requirements Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2022-08-24	Proposal
BS ISO 6475	Implants for surgery -- Metal bone screws with asymmetrical thread -- Requirements and mechanical test methods Categories: Implants for surgery, prosthetics and orthotics Approval begins : 2019-09-23	Approval
BS ISO 5838-1	Implants for surgery - Metallic skeletal pins and wires. - Part 1: General requirements Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2021-09-30	Drafting
BS ISO 18967-1	Implants for surgery — Bone anchoring systems — Part 1: Part 1: Impact, expandable and threaded suture anchors requirements Categories: Unclassified documents Drafting begins : 2024-08-08	Drafting
BS ISO 18192-3	Implants for surgery — Wear of total intervertebral spinal disc prostheses —. Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2024-05-21	Drafting
BS ISO 15142-3	Implants for surgery - Metal intramedullary nailing systems. - Part 3: Connection devices and reamer diameter measurements Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2021-09-30	Drafting

Published (11)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
BS ISO 9714-1:2012	Orthopaedic drilling instruments. Drill bits, taps and countersink cutters Categories: Surgical instruments and materials \| Implants for surgery, prosthetics and orthotics Published standard begins : 2012-06-19	Published standard
BS ISO 5838-1:2013	Implants for surgery. Metallic skeletal pins and wires. General requirements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2013-03-04	Published standard
BS ISO 19213:2017	Implants for surgery. Test methods of material for use as a cortical bone model Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2017-07-20	Published standard
BS ISO 18192-3:2017	Implants for surgery. Wear of total intervertebral spinal disc prostheses. Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2017-06-22	Published standard
BS ISO 18192-2:2010	Implants for surgery. Wear of total intervertebral spinal disc prostheses. Nucleus replacements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2010-07-20	Published standard
BS ISO 18192-1:2011+A1:2018	Implants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2019-01-02	Published standard
BS ISO 15142-3:2003	Implants for surgery. Metal intramedullary nailing systems. Connection devices and reamer diameter measurements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2003-08-20	Published standard
BS ISO 15142-2:2003	Implants for surgery. Metal intramedullary nailing systems. Locking components Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2003-08-20	Published standard
BS ISO 15142-1:2003	Implants for surgery. Metal intramedullary nailing systems. Intramedullary nails Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2003-08-20	Published standard
BS ISO 12189:2008	Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2009-02-19	Published standard

Withdrawn (4)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
BS ISO 18192-1:2011	Implants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2019-01-02	Withdrawn
BS ISO 18192-1:2008	Implants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2011-03-15	Withdrawn
BS EN ISO 14602:2010	Non-active surgical implants. Implants for osteosynthesis. Particular requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2011-11-01	Withdrawn
BS EN ISO 14602:2009	Non-active surgical implants. Implants for Osteosynthesis. Particular requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2010-05-18	Withdrawn

Standards Development

CH/150/5 - Surgical Implants - Osteosynthesis and spinal devices

Committee standards activity