This document provides the classification and model of finger orthoses, specifies the requirements, inspection rules, marking, labeling and instructions for use, and packaging, transport and storage of finger orthoses, and describes the corresponding test methods.
This document is applicable to the design, manufacture and inspection of finger orthoses.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 9056 Metal ruler
GB/T 9174 General specification for transport packages of general cargo
GB/T 10000 Human dimensions of Chinese adults
GB/T 14191.1 Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
GB/T 16432 Assistive products for persons with disability - Classification and terminology
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
GB/T 23315 Touch and close fasteners
GB/T 34410 Classification and general technology of upper limb orthoses
QB/T 1519 Fiber measuring tapes
3 Terms and definitions
For the purpose of this document, the terms and definitions given in GB/T 14191.1, GB/T 16432, GB/T 34410 and the following apply.
3.1
finger orthoses
orthoses surrounding all or part of fingers
[Source: GB/T 34410-2017, 3.3]
3.2
dynamic finger orthoses
orthoses for fingers whose position and shape will change during use
3.3
static finger orthoses
orthoses for fingers whose position and shape will not change during use
3.4
fixed (protective) finger orthoses
finger orthoses mainly used to keep fingers correctly aligned, fix and protect fingers, and prevent finger from injuries or pathologies
3.5
orthopaedic finger orthoses
finger orthoses mainly used to correct or prevent from finger deformity
3.6
compensatory finger orthoses
finger orthoses mainly used to replace or compensate for missing fingers
3.7
limited-position (antispasmodic) finger orthoses
finger orthoses mainly used to limit the range of finger movement, relieve and prevent from finger spasms
4 Classification and designation
4.1 Classification
4.1.1 By morphological changes
Finger orthoses are classified into dynamic finger orthoses and static finger orthoses according to changes of their positions and shapes of fingers during use.
4.1.2 By functions
Finger orthoses are classified into fixed (protective) finger orthoses, orthopaedic finger orthoses, compensatory finger orthoses, and limited-position (antispasmodic) finger orthoses according to their functions.
4.2 Designation
4.2.1 Composition of designation
The designation of a finger orthosis consists of a part code, a function code, a company abbreviation, a design serial number and an improvement serial number. Its composition form is shown in Figure 1.
4.2.2 Part code
The part code of the orthosis is denoted by FO.
4.2.3 Function code
"Fixed (protective)" is represented by the English letter F, "orthopaedic" by O, "compensatory" by C, and "limited-position (antispasmodic)" by L.
4.2.4 Company abbreviation
The abbreviation of a company is determined by the company itself.
4.2.5 Design serial number
The design serial number is represented by two Arabic numerals.
4.2.6 Improvement serial number
The improvement serial number is represented by an English letter, A, B, C... in turn. The original design has no letters, and the first improvement is marked with A, and so on.
Example 1: FO-O-XXXX-01: AN originally designed orthopaedic finger orthosis with a company abbreviation of XXXX and a design serial number of 01.
Example 2: FO-F-XXXX-02-A: A fixed (protective) finger orthosis improved for the first time, with a company abbreviation of XXXX, and a design serial number of 02.
Contents Foreword III 1 Scope 2 Normative references 3 Terms and definitions 4 Classification and designation 5 Requirements 6 Test methods 7 Inspection rules 8 Marking, labeling and instructions for use 9 Packaging, transport and storage
GB/T 44666-2024 Finger orthoses
1 Scope
This document provides the classification and model of finger orthoses, specifies the requirements, inspection rules, marking, labeling and instructions for use, and packaging, transport and storage of finger orthoses, and describes the corresponding test methods.
This document is applicable to the design, manufacture and inspection of finger orthoses.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 9056 Metal ruler
GB/T 9174 General specification for transport packages of general cargo
GB/T 10000 Human dimensions of Chinese adults
GB/T 14191.1 Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
GB/T 16432 Assistive products for persons with disability - Classification and terminology
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
GB/T 23315 Touch and close fasteners
GB/T 34410 Classification and general technology of upper limb orthoses
QB/T 1519 Fiber measuring tapes
3 Terms and definitions
For the purpose of this document, the terms and definitions given in GB/T 14191.1, GB/T 16432, GB/T 34410 and the following apply.
3.1
finger orthoses
orthoses surrounding all or part of fingers
[Source: GB/T 34410-2017, 3.3]
3.2
dynamic finger orthoses
orthoses for fingers whose position and shape will change during use
3.3
static finger orthoses
orthoses for fingers whose position and shape will not change during use
3.4
fixed (protective) finger orthoses
finger orthoses mainly used to keep fingers correctly aligned, fix and protect fingers, and prevent finger from injuries or pathologies
3.5
orthopaedic finger orthoses
finger orthoses mainly used to correct or prevent from finger deformity
3.6
compensatory finger orthoses
finger orthoses mainly used to replace or compensate for missing fingers
3.7
limited-position (antispasmodic) finger orthoses
finger orthoses mainly used to limit the range of finger movement, relieve and prevent from finger spasms
4 Classification and designation
4.1 Classification
4.1.1 By morphological changes
Finger orthoses are classified into dynamic finger orthoses and static finger orthoses according to changes of their positions and shapes of fingers during use.
4.1.2 By functions
Finger orthoses are classified into fixed (protective) finger orthoses, orthopaedic finger orthoses, compensatory finger orthoses, and limited-position (antispasmodic) finger orthoses according to their functions.
4.2 Designation
4.2.1 Composition of designation
The designation of a finger orthosis consists of a part code, a function code, a company abbreviation, a design serial number and an improvement serial number. Its composition form is shown in Figure 1.
4.2.2 Part code
The part code of the orthosis is denoted by FO.
4.2.3 Function code
"Fixed (protective)" is represented by the English letter F, "orthopaedic" by O, "compensatory" by C, and "limited-position (antispasmodic)" by L.
4.2.4 Company abbreviation
The abbreviation of a company is determined by the company itself.
4.2.5 Design serial number
The design serial number is represented by two Arabic numerals.
4.2.6 Improvement serial number
The improvement serial number is represented by an English letter, A, B, C... in turn. The original design has no letters, and the first improvement is marked with A, and so on.
Example 1: FO-O-XXXX-01: AN originally designed orthopaedic finger orthosis with a company abbreviation of XXXX and a design serial number of 01.
Example 2: FO-F-XXXX-02-A: A fixed (protective) finger orthosis improved for the first time, with a company abbreviation of XXXX, and a design serial number of 02.
Contents of GB/T 44666-2024
Contents
Foreword III
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and designation
5 Requirements
6 Test methods
7 Inspection rules
8 Marking, labeling and instructions for use
9 Packaging, transport and storage
