British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee is responsible for UK input into ISO/TC168 and CEN/TC293 standardization in the field of prosthetics and orthotics.

Committee standards activity

In Progress (8)

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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/TC 168/N 344 - ISO/NP 22523	“External limb prostheses and external orthoses - Requirements and test methods” Categories: Information management \| Vocabularies \| Health care technology \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2020-01-09	Proposal
ISO/TC 168, ISO/NP 8549-2 (Ed 3)	Prosthetics and orthotics -- Vocabulary -- Part 2: Terms relating to external limb prostheses Categories: Information management \| Vocabularies \| Health care technology \| Standardization. General rules \| Healthcare \| Medical equipment \| Implants for surgery, prosthetics and orthotics Proposal begins : 2021-03-26	Proposal
BS ISO 8549-4	Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Public comment begins : 2024-11-12	Public comment
BS ISO 13404-3	Prosthetics and orthotics — External orthoses and orthotic components — Uses, functions, classifications and description — Part 3: Orthoses for the spine and head Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 13404-2	Prosthetics and orthotics — External orthoses and orthotic components — Uses, functions, classification and description — Part 2: Upper limb orthoses Categories: Unclassified documents Proposal begins :	Proposal
BS EN ISO 22675:2024	Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods Categories: Implants for surgery, prosthetics and orthotics Approval begins : 2024-10-09	Approval
BS EN ISO 22523	External limb prostheses and external orthoses — Requirements and test methods Categories: Implants for surgery, prosthetics and orthotics Comment resolution begins : 2024-12-30	Comment resolution
BS EN ISO 10328	Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods Categories: Unclassified documents Drafting begins : 2023-12-27	Drafting

Published (29)

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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 4549:2023	Orthotics. Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2023-07-28	Published standard
PD ISO/TS 16955:2016	Prosthetics. Quantification of physical parameters of ankle foot devices and foot units Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2016-06-23	Published standard
BS ISO 8551:2020	Prosthetics and orthotics. Functional deficiencies. Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-03-11	Published standard
BS ISO 8549-4:2020	Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Published standard begins : 2020-09-14	Published standard
BS ISO 8549-3:2020	Prosthetics and orthotics. Vocabulary. Terms relating to orthoses Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Published standard begins : 2020-09-21	Published standard
BS ISO 8549-2:2023	Prosthetics and orthotics. Vocabulary. Terms relating to external limb prostheses Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Published standard begins : 2023-10-26	Published standard
BS ISO 8549-1:2020	Prosthetics and orthotics. Vocabulary. General terms for external limb prostheses and external orthoses Categories: Implants for surgery, prosthetics and orthotics \| Health care technology Published standard begins : 2020-09-22	Published standard
BS ISO 8548-5:2003	Prosthetics and orthotics. Limb deficiencies. Description of the clinical condition of the person who has had an amputation Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2003-10-07	Published standard
BS ISO 8548-3:2025	Prosthetics and orthotics. Limb deficiencies. Method of describing the residual limb after upper limb amputation Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2025-01-23	Published standard
BS ISO 8548-2:2020	Prosthetics and orthotics. Limb deficiencies. Method of describing lower limb amputation stumps Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-04-06	Published standard

Withdrawn (8)

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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 8551:2003	Prosthetics and orthotics. Functional deficiencies. Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2020-03-11	Withdrawn
BS ISO 8549-4:2014	Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Withdrawn begins : 2020-09-14	Withdrawn
BS ISO 8549-2:2020	Prosthetics and orthotics. Vocabulary. Terms relating to external limb prostheses and wearers of these prostheses Categories: Health care technology \| Implants for surgery, prosthetics and orthotics Withdrawn begins : 2023-10-26	Withdrawn
BS ISO 29782:2008	Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2023-09-22	Withdrawn
BS ISO 13404:2007	Prosthetics and orthotics. Categorization and description of external orthoses and orthotic components Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2024-11-25	Withdrawn
BS EN ISO 22675:2006	Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2016-07-01	Withdrawn
BS EN ISO 10328:2006	Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2016-07-05	Withdrawn
BS EN 12523:1999	External limb prostheses and external orthoses. Requirements and test methods Categories: Implants for surgery, prosthetics and orthotics Withdrawn begins : 2006-10-19	Withdrawn

Standards Development

CH/168 - Prosthetics and orthotics

Committee standards activity