GB/T 44666-2024 英文版/翻译版 指矫形器
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指矫形器
1 范围
本文件给出了指矫形器的分类和型号，规定了指矫形器的要求、检验规则、标志标签、使用说明书、包装、运输及贮存，描述了对应的试验方法。
本文件适用于指矫形器的设计、制作与检验。
2 规范性引用文件
下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。
GB/T 191 包装储运图示标志
GB/T 9056 金属直尺
GB/T 9174 一般货物运输包装通用技术条件
GB/T 10000 中国成年人人体尺寸
GB/T 14191.1 假肢学和矫形器学术语 第1部分：体外肢体假肢和体外矫形器的基本术语
GB/T 16432 康复辅助器具 分类和术语
GB/T 16886.5-2017 医疗器械生物学评价 第5部分：体外细胞毒性试验
GB/T 16886.10-2017 医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
GB/T 23315 粘扣带
GB/T 34410 上肢矫形器的分类及通用技术条件
QB/T 1519 纤维卷尺
3 术语和定义
GB/T 14191.1 、GB/T 16432和 GB/T 34410界定的以及下列术语和定义适用于本文件。
3.1
指矫形器 finger orthoses
围绕手指全部或部分的矫形器。
[来源：GB/T 34410—2017,3.3]
3.2
动态型指矫形器 dynamic finger orthoses
使用过程中手指的位置、形态会发生变化的指矫形器。
3.3
静态型指矫形器 static finger orthoses
使用过程中手指的位置、形态不会发生变化的指矫形器。
3.4
固定(保护)型指矫形器 fixed(protective)finger orthoses
以保持手指正确对线，固定、保护手指，防止指部受伤或病变为主要功能的指矫形器。
3.5
矫正型指矫形器 orthopaedic finger orthoses
以矫正或预防指部畸形为主要功能的指矫形器。
3.6
代偿型指矫形器 compensatory finger orthoses
以代替或补偿手指缺失功能为主要功能的指矫形器。
3.7
限位(抗痉挛)型指矫形器 limited-position (antispasmodic) finger orthoses
以限制手指活动范围，缓解、预防指部肌肉痉挛为主要功能的指矫形器。
4 分类和型号
4.1 分类
4.1.1 按形态变化情况分类
指矫形器按使用过程中手指的位置、形态变化情况分为动态型指矫形器、静态型指矫形器。
4.1.2 按功能分类
指矫形器按功能分为固定(保护)型指矫形器、矫正型指矫形器、代偿型指矫形器、限位(抗痉挛)型 指矫形器。
4.2 型号
4.2.1 型号组成
指矫形器的型号由部位代号、功能代号、公司简称、设计序列号和改进序列号构成，其组成形式见 图1。
……
4.2.2 部位代号
指矫形器的部位代号用FO表示。
4.2.3 功能代号
固定(保护)用英文字母F表示，矫正用英文字母O表示，代偿用英文字母C表示，限位(抗痉挛)用英文字母L表示。
4.2.4 公司简称
公司简称由公司确定。
4.2.5 设计序列号
设计序列号用2位阿拉伯数字表示。
4.2.6 改进序列号
改进序列号用一位英文字母A、B、C……依次表示，原始设计不加字母，第一次改进标记为A，以此类推。
示例1:FO-O-XXXX-01:公司简称为XXXX的、设计序列号为01的、原始设计的矫正型指矫形器。
示例2:FO-F-XXXX-02-A:公司简称为XXXX的、设计序列号为02的、第一次改进设计的固定(保护)型指矫形器。
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.
