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GB 22457-2008Service of fitting prosthesis (English PDF)

假肢配置服务

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China

Level / Type

National · Mandatory

Issue date

September 19, 2008

Implementation date

March 1, 2009

Scope

GB 22457-2008 is the English-translated version of 假肢配置服务.

GB 22457-2008 specifies the service requirements for prosthesis fitting and applies to all types of institutions that fit prostheses; Clause 6 is mandatory and the remainder of the standard is recommended.

It covers the whole service chain: reception and the three-part prosthesis medical record (patient particulars, examination with dimension measurement, prescription), the prosthesis prescription issued by the first-consultation prosthetist, the fitting agreement with its minimum content, retention of records and agreements for at least 15 years, preparation, fabrication and training in use.

Fabrication is generally to be completed within 30 days of the agreement, and quality inspection includes initial and final fit assessments with separate check lists for upper and lower limb prostheses.

Further clauses deal with delivery with a certificate of conformity, warranty card and instructions, marking, packaging, transport and storage, and follow-up, while normative and informative annexes give the medical record front page, examination form, dimension measurement records, prescription, model agreement, warranty card, product instructions and follow-up record form.

It was issued on 19 September 2008 and has been in force since 1 March 2009. Classification: ICS 11.040.40, CCS C45. The document runs to 25 pages, delivered complete in English translation.

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Document preview — GB 22457-2008

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's Republic of China; Standardization Administration of China

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
5 Establishment of the management system
6 General requirements for the fitting of prostheses
7 Delivery of the prosthesis
8 Marking, packaging, transport and storage
9 Follow-up

3 Terms and definitions

4 General principles

5 Establishment of the management system

6 General requirements for the fitting of prostheses

7 Delivery of the prosthesis

8 Marking, packaging, transport and storage

9 Follow-up

Foreword

Clause 6 of this standard is mandatory; the remainder is recommended.

Annex A, Annex B, Annex C, Annex D and Annex H of this standard are normative; Annex E, Annex F and Annex G are informative.

This standard was proposed by the Ministry of Civil Affairs of the People's Republic of China.

This standard is under the jurisdiction of the National Technical Committee on Rehabilitation and Special Equipment for Persons with Disabilities of Standardization Administration of China (SAC/TC 148).

Main drafting organisations of this standard: National Research Center for Rehabilitation Technical Aids, China Rehabilitation Research Center, Beijing Jingbo Modern Prosthetic and Orthotic Technology Co., Ltd., Shanghai Jingbo Prosthetic and Orthotic Co., Ltd., Zhejiang Prosthetic Research and Rehabilitation Center, Beijing Prosthetic and Orthotic Technology Center.

Main drafters of this standard: Ma Fengling, Liu Junling, Cao Xuejun, Cai Dawei, Meng Hongwei, Zhao Liwei, Yao Juan, Tao Jing, Qu Jianguo, Sun Gang, Wu Guoshi.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

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Editions of GB 22457

Edition	Title	Revision	Status
GB 22457-2008	Service of fitting prosthesis	current edition	Current

This page sells the current edition, GB 22457-2008. Earlier editions are listed for reference only.

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