British Standards Institution

Sector: Governance & Resilience

Categories: Application layer | Medical equipment | Testing. Mechanical | Implants for surgery, prosthetics and orthotics

Overview: Under the direction of CH/150, is responsible for standardization in the area of Surgical implants – bone and joint replacements and is responsible for the UK input to for ISO/TC 150/SC 4 Bone and joint replacements

Committee standards activity

In Progress (18)

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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/TR 9586	valgus and varus in orthopaedic surgery Categories: Unclassified documents Comment resolution begins : 2018-10-05	Comment resolution
BS ISO 7207-2	Implants for surgery — Components for partial and total knee joint prostheses —. Part 2: Articulating surfaces made of metal, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Public comment begins : 2023-11-27	Public comment
BS ISO 7206-6	Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 7206-2	Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 7206-12	ISO 7206-12 Implants for surgery. Partial and total hip joint prostheses. Part 12: Deformation test method for press-fit acetabular components Categories: Implants for surgery, prosthetics and orthotics Public comment begins : 2024-09-24	Public comment
BS ISO 7206-1	Implants for surgery — Partial and total hip joint prostheses —. Part 1: Classification and designation of dimensions Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 24085-2	Implants for Surgery - Partial and total shoulder joint prosthesis. - Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2020-06-13	Drafting
BS ISO 24085-1	Implants for Surgery - Partial and total shoulder joint prosthesis. - Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2020-06-13	Drafting
BS ISO 21536:2007/Amd 2	Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 2 Categories: Unclassified documents Drafting begins : 2014-09-20	Drafting
BS ISO 16436-2	Implants for surgery — Wear of total shoulder-joint prostheses —. Part 2: Force and displacement parameters for wear-testing machines and corresponding environmental conditions for test of reverse total shoulder-joint prostheses Categories: Unclassified documents Proposal begins :	Proposal

Published (24)

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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 7207-2:2011+A2:2020	Implants for surgery. Components for partial and total knee joint prostheses. Articulating surfaces made of metal, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-07-01	Published standard
BS ISO 7207-1:2007	Implants for surgery. Components for partial and total knee joint prostheses. Classification, definitions and designation of dimensions Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2008-12-11	Published standard
BS ISO 7206-6:2013	Implants for surgery. Partial and total hip joint prostheses. Endurance properties testing and performance requirements of neck region of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2013-11-13	Published standard
BS ISO 7206-4:2010+A1:2016	Implants for surgery. Partial and total hip joint prostheses. Determination of endurance properties and performance of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2016-04-13	Published standard
BS ISO 7206-2:2011+A1:2016	Implants for surgery. Partial and total hip joint prostheses. Articulating surfaces made of metallic, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2016-10-10	Published standard
BS ISO 7206-13:2016+A1:2022	Implants for surgery. Partial and total hip joint prostheses. Determination of resistance to torque of head fixation of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2022-06-17	Published standard
BS ISO 7206-12:2016	Implants for surgery. Partial and total hip joint prostheses. Deformation test method for acetabular shells Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2016-09-29	Published standard
BS ISO 7206-10:2018+A1:2021	Implants for surgery. Partial and total hip-joint prostheses. Determination of resistance to static load of modular femoral heads Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2021-05-24	Published standard
BS ISO 19233-1:2017	Implants for surgery. Orthopaedic joint prosthesis. Procedure for producing parametric 3D bone models from CT data of the knee Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2017-06-23	Published standard
BS ISO 17853:2011	Wear of implant materials. Polymer and metal wear particles. Isolation and characterization Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2011-03-15	Published standard

Withdrawn (31)

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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 7207-2:2011+A1:2016	Implants for surgery. Components for partial and total knee joint prostheses. Articulating surfaces made of metal, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2020-07-01	Withdrawn
BS ISO 7207-2:2011	Implants for surgery. Components for partial and total knee joint prostheses. Articulating surfaces made of metal, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2016-08-31	Withdrawn
BS ISO 7206-4:2010	Implants for surgery. Partial and total hip joint prostheses. Determination of endurance properties and performance of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2016-04-13	Withdrawn
BS ISO 7206-4:2002	Implants for surgery. Partial and total hip joint prostheses. Determination of endurance properties of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2010-07-30	Withdrawn
BS ISO 7206-2:2011	Implants for surgery. Partial and total hip joint prostheses. Articulating surfaces made of metallic, ceramic and plastics materials Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2016-10-10	Withdrawn
BS ISO 7206-13:2016	Implants for surgery. Partial and total hip joint prostheses. Determination of resistance to torque of head fixation of stemmed femoral components Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2022-06-17	Withdrawn
BS ISO 7206-10:2018	Implants for surgery. Partial and total hip-joint prostheses. Determination of resistance to static load of modular femoral heads Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2021-05-24	Withdrawn
BS ISO 7206-10:2003	Implants for surgery. Partial and total hip-joint prostheses. Determination of resistance to static load of modular femoral heads Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2018-08-10	Withdrawn
BS ISO 7206-1:2008	Implants for surgery. Partial and total hip joint prostheses. Classification and designation of dimensions Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2009-05-21	Withdrawn
BS ISO 17853:2010	Wear of implant materials. Polymer and metal wear particles. Isolation and characterization Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2011-03-15	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
British Healthcare Trades Association
Committee Manager
Deputy Chair
DePuy Synthes
Imperial College London
Institution of Mechanical Engineers
requirements
Simulation Solutions Ltd
University of Birmingham
University of Leeds
University of Sheffield

Liaisons with other committees

Chair - CH/150
Chair - CH/150/5
Expert - Simulators for testing wear of orthopaedic implants
Individual Capacity - Bone and Joint Replacements
Individual Capacity - Clinical evaluation and post-market surveillance
Individual Capacity - Hip Replacements & Oncology Implant Devices Expert
Individual Capacity - Medical Engineering Expert
Individual Capacity - Metrology
Individual Capacity - Orthopaedics Reasearch & Development
Individual Capacity - Shoulders, Elbows and Ankles Expertise.
Individual Capacity – ISO WGs
Individual Capacity – Mechanical engineering of implants & instruments

BSI roles

Committee Chair

Standards Development

CH/150/4 - Surgical Implants - Bone and Joint Replacements

Committee standards activity