YY/T 0127.6-1999Biological evaluation of dental materials - Unit 2: Biological test methods of dental materials - Dominant lethal test (English PDF)
口腔材料生物学评价 第2单:口腔材料生物试验方法 显性致死试验
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 7, 1999
Implementation date
October 1, 1999
Scope
YY/T 0127.6-1999 is the English-translated version of 口腔材料生物学评价 第2单:口腔材料生物试验方法 显性致死试验.
YY/T 0127.6-1999 sits in the recommended Chinese medical device industry series on the biological evaluation of dental materials and covers the dominant lethal test.
It sets out how that test is carried out on materials used in the mouth. The outcome is used to judge whether a dental material induces dominant lethal effects, one of the genetic toxicity endpoints examined across the series.
The standard is a non-equivalent adoption of ISO/TR 7405-1984 and of OECD Test Guideline No. 478-1984, and it also draws on YY/T 0244-1996 and the drug approval procedures of the Chinese Ministry of Health. Issued on 7 June 1999, it has applied since 1 October 1999.
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Document preview — YY/T 0127.6-1999
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0127.6-1999 cites the following standards, which apply in full or in part through the references made to them in its clauses.
ISO/TR 7405-1984
YY/T 0244-1996
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
ISO/TR 7405-1984
Similar standards
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Related Standards
YY/T 0244-1996 — Biological Test Methods of Dental Materials - Short Term Systemic Toxicity Test: Oral Route
YY/T 0127.7-2017 — Biological evaluation of medical devices used in dentistry - Part 7: Pulp and dentine usage test
YY/T 0127.5-1999 — Biological evaluation of dental materials - Unit 2: Biological test methods of dental materials - Inhalation toxicity test
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YY/T 0127.6-1999
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