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

Foreword

This document was issued on 19 September 2008 by the State Administration for Market Regulation and the Standardization Administration of the People's Republic of China, and has been in force since 1 March 2009.

It is the first edition of this standard.

Classification: ICS 11.040.40, CCS C45.

1 Scope

GB 22457-2008 is the Chinese national standard on service of fitting prosthesis, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China. It was issued on 19 September 2008 by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China, and has been in force since 1 March 2009. Classification: ICS 11.040.40, CCS C45. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

About this edition

GB 22457-2008 is the first edition of this standard. It was issued on 19 September 2008 and has been in force since 1 March 2009.

There is no earlier edition to compare it with, so a specification that has to refer to this subject can only cite GB 22457-2008 itself.

The interval between issue and effect is the transition period. It exists so that producers, laboratories and buyers can requalify products, revise procedures and use up documentation before the new text becomes the one that applies. The date on this page is the official one from the record of the Standardization Administration.

Classification and status

GB 22457-2008 is classified under ICS 11.040.40, in the field of health care technology. ICS is the International Classification for Standards, the same scheme used by ISO and by the national bodies of most countries, which is what allows a Chinese standard to be placed beside its foreign counterparts on subject rather than on number.

Its Chinese Standard Classification code is CCS C45. CCS is the domestic scheme, a letter for the sector and two digits for the subject within it, and it is the code by which the standard is filed and searched in China.

The GB prefix without a suffix marks a mandatory national standard: compliance is required by law for the products or activities within its scope, and a product that does not meet it may not lawfully be placed on the Chinese market.

How a Chinese national standard is set out

Chinese national standards are drafted to the rules of GB/T 1.1, which fixes the order in which a standard is set out. The document opens with a foreword recording the issuing bodies, the relationship to any previous edition and the technical committee responsible for it. Clause 1 is the scope. Clause 2 lists the normative references — the other standards that have to be applied together with this one, and without which its requirements cannot be met. Clause 3 gives the terms and definitions. The technical clauses follow: the requirements themselves, the test or measurement methods by which conformity is established, the inspection rules that say how a lot is sampled and judged, and, for a product standard, the provisions on marking, packaging, transport and storage. Annexes, normative or informative, come last.

GB 22457-2008 runs to 22 pages in the English translation. What is delivered is the complete document in that order: every clause, every table, every figure and every annex of the Chinese original, with the same numbering, so that a reference to a clause number in a contract or a test report points to the same place in both languages.