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GB/T 18375.5-2002Prosthetics -- Structural testing of lower limb prostheses -- Part 5: Supplementary structural tests (English PDF)

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee

Level / Type

National · Recommended

Issue date

June 11, 2004

Implementation date

January 1, 2005

Scope

GB/T 18375.5-2002 (Prosthetics -- Structural testing of lower limb prostheses -- Part 5: Supplementary structural tests) is available as an English-translated PDF.

GB/T 18375.5-2002 is the Chinese standard "Prosthetics -- Structural testing of lower limb prostheses -- Part 5: Supplementary structural tests". This standard specifies: under the skin fake skin static and dynamic testing process, in this process, addition to a special case, are generated by a complex test force test load.

On the test sample depending on the load of each component of composite load Peak, these peaks typically occur during walking when the support phase different instantly.

It was issued by General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee. Issued on 2004-06-11, in force from 2005-01-01. It cites 8 other standards.

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Document preview — GB/T 18375.5-2002

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C45

Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee

Contents

  • [Preview only]
  • 1 Scope
  • 2 Normative references
  • 2.1 Radiation
  • 3 Terms and definitions
  • 3.2 Symbols
  • 3.3 Main Equipment
  • 3.4 Preparation Before the Test
  • 3.5 Culture Medium
  • 3.6 Test Substance Bacterial Inhibition Proof Test
  • 3.7 Test Method
  • 4 X-ray Equipment
  • 4.1 General
  • 4.2 Focimeter measuring method
  • 4.3 Electrically powered wheelchairs of class A
  • 4.4 Electrically powered wheelchairs of class B
  • 4.5 Electrically powered wheelchairs of class C
  • 4.6 Electrically powered wheelchairs (scooter design)
  • 5 Medical X-ray Techniques
  • 5.2 Full overall length
  • 5.3 Overall width
  • 6 Protection Against X-ray
  • 7 X-ray Measuring Instruments
  • 8 Cytotoxicity Test
  • 9 Sensitization Test (Maximum Dose Method)

1 Foreword

GB/T 18375.5-2002 was issued by General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee on 11 June 2004.

It is one of 12 parts of the GB/T 18375 series.

The GB/T prefix marks a recommended standard. It is not law in itself: it becomes binding when a contract names it, when a regulation or a mandatory standard refers to it, or when a producer declares conformity with it.

2 Scope Preview

This standard specifies: under the skin fake skin static and dynamic testing process, in this process, addition to a special case, are generated by a complex test force test load. On the test sample depending on the load of each component of composite load Peak, these peaks typically occur during walking when the support phase different instantly. It was issued by General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee.

GB/T 18375.5-2002 falls under ICS 11.040.40, in the field of health care technology.

This catalogue holds 845 other GB/T standards in that field.

In this catalogue, GB/T standards carry edition years from 1963 to 2026.

3 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document.

GB/T 14191-1993 — Prosthetics and orthotics -- Vocabulary -- Part 1: General terms for external limb prostheses and external orthoses

GB/T 18375.1-2001 — Prosthetics - Structural testing of lower-limb prostheses - Part 1: Test configurations

GB/T 18375.2-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 2: Test samples

GB/T 18375.3-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 3: Principle structural tests

GB/T 18375.4-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 4: Loading parameters of principal structural tests

GB/T 18375.6-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 6: Loading parameters of supplementary structural tests

GB/T 18375.7-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 7: Test submission document

GB/T 18375.8-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 8: Test report

4 Where this standard sits

It cites 8 standards, among them GB/T 14191-1993, GB/T 18375.1-2001, GB/T 18375.2-2001, listed in full above.

It is one part of the GB/T 18375 series, of which this catalogue holds 12 parts.

5 About this standard

Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee

English translation: about 9 pages (approximate)

6 Related standards

Other parts of this standard:

GB/T 18375-2024 — Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods

GB/T 18375.1-2001 — Prosthetics - Structural testing of lower-limb prostheses - Part 1: Test configurations

GB/T 18375.2-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 2: Test samples

GB/T 18375.3-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 3: Principle structural tests

GB/T 18375.4-2001 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 4: Loading parameters of principal structural tests

GB/T 18375.6-2002 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 6: Loading parameters of supplementary structural tests

GB/T 18375.6-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 6: Loading parameters of supplementary structural tests

GB/T 18375.7-2002 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 7: Test submission document

GB/T 18375.7-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 7: Test submission document

GB/T 18375.8-2002 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 8: Test report

GB/T 18375.8-2004 — Prosthetics -- Structural testing of lower-limb prostheses -- Part 8: Test report

Other editions:

GB/T 18375.5-2004 (later edition)

Standards on related subjects:

YY/T 1680-2020 — Allogeneic grafts—In vivo evaluation of osteoinductive potential for materials containing demineralized bone

GB/T 39381.1-2020 — Cardiovascular implants - Vascular device-drug combination products - Part 1: General requirements

YY/T 1561-2017 — Tissue engineering medical device products - Residual alpha-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives

GB/Z 45288.7-2026 — Artificial intelligence - Large-scale model - Part 7: Speech large-scale model

GB/Z 44426.7-2026 — Assistive products for tissue integrity when lying down - Part 7: Foam properties, characteristics and performance

GB/T 19545.2-2026 — Walking aids manipulated by one arm - Requirements and test methods - Part 2: Axillary crutches

7 Classification and status

International classification (ICS): 11.040.40

Chinese Standard Classification (CCS): C 45

Prefix GB/T: recommended standard.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.

Referenced standards

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