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GB/T 18027-2021Components of electric upper limb (English PDF)

电动上肢假肢部件

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 11, 2021

Implementation date

October 11, 2021

Scope

GB/T 18027-2021 is the English-translated version of 电动上肢假肢部件.

GB/T 18027-2021 is the Chinese national standard for the components of an electric upper limb prosthesis. It gives the technical requirements, the test methods, the inspection rules and the provisions on marking, packaging, transport and storage.

It applies to the components of an electric upper limb prosthesis: the hands, the wrist joints, the elbow joints and the cosmetic gloves. Prosthesis makers, rehabilitation centres and the bodies that check the devices use it.

It replaces GB/T 18027-2008, was issued on 11 October 2021 and applies from the same date.

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Document preview — GB/T 18027-2021

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 45
Replacing
GB/T 18027-2008

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Technical requirements
  • 5 Test method
  • 6 Inspection rules
  • 7 Marking, packaging, transportation and storage

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.

This document replaces GB/T 18027-2008 "Electric Upper Limb Prosthetic Parts". Compared with GB/T 18027-2008, except for structural adjustments and In addition to editorial changes, the main technical changes are as follows.

a) The terms "bionic hand" and "smart hand" have been added (see 3.4, 3.5);

b) The load angular velocity, initial load input power, and rated load input power in Table 2 are deleted (see Table 2 in the.2008 edition);

c) Deleted the angular velocity of load motion, initial load input power, and rated load input power in Table 3 (see Table 3 in the.2008 edition);

d) Deleted the "tensile load" in the glove performance test (see 5.5.2 of the.2008 edition);

e) Deleted "and stretch from 130°~5°" in the initial load angular velocity test of the elbow joint (see 5.1.2.3 of the.2008 edition);

f) Added "humidity test" (see 4.3.3);

g) Modified the "Noise Detection Method" (see 5.7, 5.1.4.7 of the.2008 edition);

h) The requirements for the waterproof level have been added (see 4.7).

1 Scope

This document specifies the technical requirements, experimental methods, inspection rules, markings, packaging, transportation and store.

This document is applicable to components such as artificial hands, wrist joints, elbow joints and gloves of electric upper limb prostheses.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 528-2009 Determination of tensile stress and strain properties of vulcanized rubber or thermoplastic rubber

GB/T 2423.1-2008 Environmental testing of electric and electronic products Part 1: Test method Experiment A. Low temperature

GB/T 2423.2-2008 Environmental testing of electric and electronic products Part 2: Test method Experiment B. High temperature

GB/T 3767 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources

GB/T 3785.1-2010 Electroacoustic Sound Level Meter Part 1: Specification

GB/T 4208-2017 Enclosure protection grade (IP code)

GB 8897.4 Primary batteries Part 4: Safety requirements for lithium batteries

GB/T 9174 General technical requirements for general cargo transportation packaging

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

GB 19521.11 Safety Code for Inspection of Dangerous Characteristics of Dangerous Goods of Lithium Battery Pack

3 Terms and definitions

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

3.1 Electric upper limb prosthesis

The upper limb prosthesis of the artificial limb joint and the hand device is driven by a micro-motor.

3.2 Myoelectric controlled electric upper limb prosthesis myoelectric controlled electric arm

An electric upper limb prosthesis that uses the human body's electromyographic signal to control.

3.3 Switch controlled electric arm

An electric upper limb prosthesis controlled by a switch.

3.4 Bionichand

An electric prosthetic hand capable of active and independent movement of all five fingers.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of GB/T 18027

EditionTitleRevisionStatus
GB/T 18027-2021Components of electric upper limbcurrent editionCurrent
GB/T 18027-2008Components of electric upper limbprevious editionSuperseded

This page sells the current edition, GB/T 18027-2021. Earlier editions are listed for reference only.

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