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YY/T 0467-2003Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices (English PDF)

医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 22, 2003

Implementation date

January 1, 2004

Scope

YY/T 0467-2003 is the English-translated version of 医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南.

YY/T 0467-2003 is the Chinese pharmaceutical industry standard covering medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices.

It was issued on 22 June 2003 and has been in force since 1 January 2004, as a first edition. The document is under the responsibility of the National Medical Products Administration.

This page is published from the official record of the 2003 edition. The figures, limits and tables the standard contains are those of the document itself, delivered in full with the English translation.

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Document preview — YY/T 0467-2003

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

[Preview only]
1 Scope
2 Normative References
3 Terms and definitions
4 Requirements
4.1 Chemical composition
4.2 Biocompatibility
4.3 Performance of tomographic images
5 Observation
6 Result Assessment
7 Marking
8 Test report
9 Sample processing

1 Foreword

YY/T 0467-2003 was issued by National Medical Products Administration of the People's Republic of China on 22 June 2003.

The YY/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.

The document runs to 16 pages in English translation.

2 Scope Preview

YY/T 0467-2003 carries no ICS number and no Chinese Standard Classification code.

This catalogue holds 2,111 other YY/T standards.

Of the 977 YY/T standards that do carry an ICS number, 960 (98%) fall under ICS 11, in the field of health care technology.

3 About this standard

Issued by: National Medical Products Administration of the People's Republic of China

English translation: about 16 pages

4 Related standards

Other editions:

YY/T 0467-2016 (later edition)

Standards on related subjects:

YY 0505-2012 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

YY/T 0340-2009 — Implants for surgery Fundamental principles

YY/T 0454-2008 — Disposable scalpel

YY/T 0297-2026 — General requirements for clinical investigation of medical devices

YY/T 0474-2025 — Surgical Implants - Polylactide Homopolymers, Copolymers, and Blends - In Vitro Degradation Tests

5 Classification and status

Chinese Standard Classification (CCS): C 30

Prefix YY/T: recommended standard.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

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