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GB/T 39868-2021Ankle foot orthoses (English PDF)

踝足矫形器

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 9, 2021

Implementation date

March 9, 2021

Scope

GB/T 39868-2021 is the English-translated version of 踝足矫形器.

GB/T 39868-2021 is the Chinese national standard for ankle foot orthoses. It gives the classification and the models, the technical requirements, the inspection methods, the inspection rules and the provisions on marking, packaging, transport and storage.

It applies to the ankle foot orthoses used after a fracture of the foot or ankle, after an ankle injury, and in spasticity, drop foot, inversion and eversion, and not to those made of soft materials.

Orthotic workshops, rehabilitation services and inspectors use it. Issued on 9 March 2021, it applies from the same date.

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Document preview — GB/T 39868-2021

National Standard of the People's Republic of China

ICS: 11.180.01
Classification: C 45

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and model
5 Technical requirements
6 Inspection method
7 Inspection rules
8 Marks, packaging marks, instructions for use
9 Packaging, transportation and storage
Appendix A (Normative Appendix) Technical requirements for the design and structure of ankle-foot orthoses

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the classification and model, technical requirements, inspection methods, inspection rules, marking, packaging, transportation, and storage of ankle and foot orthoses.

This standard applies to ankle and foot orthoses. This product is used for foot and ankle fractures, ankle joint injuries, spasms, foot drop, foot varus, foot valgus, etc.

Ankle and foot orthoses used, but do not include ankle and foot orthoses made of soft materials.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 191 Packaging, storage and transportation pictorial signs

GB/T 10000 Chinese adult human body size

GB/T 14191.1 Terminology of prosthetics and orthotics-Part 1: Basic terminology of external limb prostheses and external orthoses

GB/T 16432 Classification and terminology of rehabilitation assistive devices

3 Terms and definitions

The following terms and definitions defined in GB/T 14191.1 and GB/T 16432 apply to this document.

3.2 Protective ankle foot orthosis

The main function of rehabilitation is to protect the injured distal leg bones, ankle joints, foot bones, and foot joints during exercise. Assistive devices.

3.3 Compensatory ankle foot orthosis

Rehabilitation aids that compensate for the function of the ankle dorsiflexor or plantar flexor muscles as the main function.

3.4 Antispastic ankle foot orthosis

Rehabilitation aids with the main function of relieving and preventing calf muscle spasms.

3.5 Corrective ankle foot orthosis

Rehabilitation aids with the main function of preventing or correcting deformities of the ankle and foot.

3.6 Weight-relieving ankle foot orthosis

Rehabilitation aids whose main function is to eliminate or partially eliminate the weight-bearing of the distal leg, ankle joint, and foot.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 24434-2025|GB/T 45933-2025|GB/T 41843-2022|GB/T 39871-2021|GB/T 39890-2021|GB/T 19545.2-2026

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