If you have difficulty in submitting comments on draft standards you can use a commenting template and email it to admin.start@bsigroup.com. The commenting template can be found here.

CH/168 - Prosthetics and orthotics

Sector: Governance & Resilience

Categories: Footwear | Aids. Adaptation for moving | Pharmaceutics | Health care technology | Implants for surgery, prosthetics and orthotics | Aids. Disabled persons. General | Surgical instruments and materials | Wound dressings and compresses

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 (18)
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 16955 Prosthetics — Quantification of physical parameters of ankle foot devices and foot units

Categories: Unclassified documents

Drafting begins : 2026-05-01
Drafting
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
ISO/NP TS 26761 Mechanical testing of prosthetic sockets — Requirements and test methods

Categories: Information management | Standardization. General rules

Proposal begins : 2026-05-14
Proposal
ISO/NP 26763 Prosthetics — Structural Testing of lower limb sockets — Distal Interface Components — Requirements and test methods.

Categories: Information management | Standardization. General rules

Proposal begins : 2026-05-14
Proposal
ISO/NP 26209 Prosthetics — Test methods for externally powered prosthetic hands

Categories: Information management | Standardization. General rules

Proposal begins : 2025-09-16
Proposal
BS ISO 26209 Prosthetics — Test methods for externally powered prosthetic hands

Categories: Unclassified documents

Proposal begins :
Proposal
BS ISO 21065 ISO 21065 Prosthetics and orthotics. Terms relating to the treatment and rehabilitation of persons having a lower limb amputation

Categories: Implants for surgery, prosthetics and orthotics

Public comment begins : 2026-04-21
Public comment
BS ISO 21064 Prosthetics and orthotics — Foot orthotics (pedorthics) — Uses, functions classification and description

Categories: Aids. Adaptation for moving

Public comment begins : 2026-01-07
Public comment
BS ISO 21063 ISO 21063 Prosthetics and orthotics. Soft orthoses. Uses, functions, classification and description

Categories: Implants for surgery, prosthetics and orthotics

Public comment begins : 2026-04-24
Public comment
Published (29)
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 8549-4:2026 Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation

Categories: Health care technology | Implants for surgery, prosthetics and orthotics

Published standard begins : 2026-05-26
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: Health care technology | Implants for surgery, prosthetics and orthotics

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 (10)
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 8549-4:2020 Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation

Categories: Health care technology | Implants for surgery, prosthetics and orthotics

Withdrawn begins : 2026-05-26
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 22675:2016 Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods

Categories: Implants for surgery, prosthetics and orthotics

Withdrawn begins : 2025-05-21
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 8432:2005 Spinal orthoses. Guide to design

Categories: Implants for surgery, prosthetics and orthotics

Withdrawn begins : 2026-05-22
Withdrawn