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YY/T 0268-2008Dentistry - Biological evaluation of medical devices used in dentistry - Unit 1: Evaluation and testing (English PDF)

牙科学口腔医疗器械生物学评价第1单元：评价与试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

December 1, 2009

Scope

YY/T 0268-2008 is the English-translated version of 牙科学口腔医疗器械生物学评价第1单元：评价与试验.

YY/T 0268 is the biological evaluation standard for dental devices in China.

Dentistry is treated separately from general medical device biocompatibility because the exposure is unlike anything else: materials sit permanently in the mouth in contact with saliva, mucosa, dentine and sometimes pulp, they are placed in the mouth as unset chemistry that finishes curing there, and the patient swallows whatever leaches out.

This unit covers the evaluation approach and the tests, selecting from the general biological evaluation methods the ones appropriate to those exposures. For a manufacturer of dental materials or devices seeking Chinese registration, this is the standard the biological evaluation plan and report are built on.

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Document preview — YY/T 0268-2008

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 25 April 2008 by the National Medical Products Administration and takes effect on 1 December 2009.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 0268 is the biological evaluation standard for dental devices in China. Dentistry is treated separately from general medical device biocompatibility because the exposure is unlike anything else: materials sit permanently in the mouth in contact with saliva, mucosa, dentine and sometimes pulp, they are placed in the mouth as unset chemistry that finishes curing there, and the patient swallows whatever leaches out. This unit covers the evaluation approach and the tests, selecting from the general biological evaluation methods the ones appropriate to those exposures. For a manufacturer of dental materials or devices seeking Chinese registration, this is the standard the biological evaluation plan and report are built on.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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