British Standards Institution

Sector: Governance & Resilience

Categories: | Health care technology | Implants for surgery, prosthetics and orthotics | Medical equipment. Other | Surgical instruments and materials

Overview: CH/150 is responsible for standardization relating to implants for surgery. It is the UK mirror committee for ISO/TC 150 Implants for Surgery and CEN/TC 285 Non-active surgical implants. The areas covered are specifications, general requirements, and terminology.

Committee standards activity

In Progress (14)

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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.
PD ISO/TS 20721	Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants Categories: Unclassified documents Comment resolution begins : 2024-12-02	Comment resolution
ISO/TC 150/SC 7 N 245, ISO/PWI TS 24560-1	Tissue engineered medical products - MRI evaluation of cartilage - Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed... Categories: Information management \| Vocabularies \| Health care technology \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Surgical instruments and materials \| Implants for surgery, prosthetics and orthotics Proposal begins : 2020-08-27	Proposal
ISO/TC 150 N 1316, ISO/NP 22926	Implants for surgery -- Design and development of synthetic anatomical bone models for testing Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2020-07-29	Proposal
ISO/NP	TR 4234 Categories: Information management \| Standardization. General rules Proposal begins : 2024-04-11	Proposal
BS ISO 8827	Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements Categories: Implants for surgery, prosthetics and orthotics Comment resolution begins : 2021-02-03	Comment resolution
BS ISO 5092	Additive manufacturing for medical — General principles — Additive manufacturing of non-active implants Categories: Implants for surgery, prosthetics and orthotics \| Public comment begins : 2024-04-12	Public comment
BS ISO 22771	Implants for surgery -- Metal bone plates -- Standard test methods for anatomic locking bone plates Categories: Unclassified documents Drafting begins : 2020-06-12	Drafting
BS ISO 19227	Implants for surgery — Cleanliness of orthopedic implants — General requirements Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 19213	Implants for surgery — Test methods of material for use as a cortical bone model Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 18192-1	Implants for surgery -- Wear of total intervertebral spinal disc prostheses. Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test Categories: Implants for surgery, prosthetics and orthotics Comment resolution begins : 2020-05-05	Comment resolution

Published (20)

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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.
PD ISO/TS 20721:2020	Implants for surgery. General guidelines and requirements for assessment of absorbable metallic implants Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-09-16	Published standard
PD ISO/TR 17327-2:2021	Non-active surgical implants. Implant coating. Reference standards related to coatings Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2021-04-13	Published standard
PD ISO/TR 14283:2018	Implants for surgery. Essential principles of safety and performance Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2018-01-10	Published standard
BS ISO 8828:2014	Implants for surgery. Guidance on care and handling of orthopaedic implants Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2014-12-03	Published standard
BS ISO 6474-2:2019	Implants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2019-03-14	Published standard
BS ISO 23089-2:2021	Implants for surgery. Pre-clinical mechanical assessment of spinal implants and particular requirements. Spinal intervertebral body fusion devices Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2021-06-03	Published standard
BS ISO 22926:2023	Implants for surgery. Specification and verification of synthetic anatomical bone models for testing Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2023-08-01	Published standard
BS ISO 22622:2019	Implants for surgery. Wear of total ankle-joint prostheses. Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2019-07-30	Published standard
BS ISO 19227:2018	Implants for surgery. Cleanliness of orthopedic implants. General requirements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2018-04-04	Published standard
BS ISO 17327-1:2018	Non-active surgical implants. Implant coating. General requirements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2018-02-28	Published standard

Withdrawn (15)

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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 12891-2:2014	Retrieval and analysis of surgical implants. Analysis of retrieved surgical implants Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2020-05-01	Withdrawn
BS ISO 12891-1:2011	Implants for surgery. Retrieval and analysis of surgical implants. Retrieval and handling Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2015-06-24	Withdrawn
BS EN ISO 5832-6:2019	Implants for surgery. Metallic materials. Wrought cobalt-nickel-chromium-molybdenum alloy Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2022-04-06	Withdrawn
BS EN ISO 16061:2015	Instrumentation for use in association with non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics \| Medical equipment. Other Withdrawn begins : 2021-04-06	Withdrawn
BS EN ISO 16061:2009	Instrumentation for use in association with non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics \| Medical equipment. Other Withdrawn begins : 2015-05-21	Withdrawn
BS EN ISO 16061:2008	Instrumentation for use in association with non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics \| Medical equipment. Other Withdrawn begins : 2009-12-10	Withdrawn
BS EN ISO 16054:2002	Implants for surgery. Minimum data sets for surgical implants Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2019-07-17	Withdrawn
BS EN ISO 14630:2012	Non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2024-12-18	Withdrawn
BS EN ISO 14630:2009	Non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2012-12-10	Withdrawn
BS EN ISO 14630:2008	Non-active surgical implants. General requirements Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2009-11-06	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
B S I Testing Product Certification
British Association of Aesthetic Plastic Surgeons
BSI Regulatory Services
Committee Manager
Deputy Chair - CH/150/SC 4
Imperial College London
Individual capacity - Patient safety, device regulation
Innovate Orthopaedics
Lucideon Limited
M H R A - Medicines and Healthcare products Regulatory Agency
Nagor - GC Aesthetics
requirements
U K Society for Biomaterials
University of Birmingham

Liaisons with other committees

Chair - CH/150/4
Chair - CH/150/5
Individual Capacity - Absorbable Metallic
Individual Capacity - Clinical evaluation and post-market surveillance
Individual Capacity - Expertise In Neurosurgical Devices
Individual Capacity - Mammary Implants Expert
Individual Capacity - Mechanical Engineering Expert
Individual Capacity - Neurosurgery
Individual Capacity - Orthopaedic Instruments
Individual Capacity - Orthopaedics Reasearch & Development
Individual Capacity – Biomaterials
Individual Capacity – ISO WGs
Individual Capacity – Plastics for Instrument Applications
Liaison - CH/194
Liaison - CH/212
Liaison – RPI/13

BSI roles

Committee Chair

Standards Development

CH/150 - Implants for surgery

Committee standards activity