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YY/T 1000.1-2005Development of medical device industry standards - Part 1: Stage division, codes and procedures (English PDF)

医疗器械行业标准的制定第1部分：阶段划分、代码和程序

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 18, 2005

Implementation date

June 1, 2006

Scope

YY/T 1000.1-2005 is the English-translated version of 医疗器械行业标准的制定第1部分：阶段划分、代码和程序.

YY/T 1000.1-2005 is the Chinese pharmaceutical industry standard covering development of medical device industry standards, Part 1: Stage division, codes and procedures.

It was issued on 18 July 2005 and has been in force since 1 June 2006, 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 2005 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 1000.1-2005

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 1000.1-2005 was issued by National Medical Products Administration of the People's Republic of China on 18 July 2005 and has been in force since 1 June 2006.

It is one of 2 parts of the YY/T 1000 series.

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.

2 Scope Preview

YY/T 1000.1-2005 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 15 pages

4 Related standards

Other parts of this standard:

YY/T 1000.2-2005 — Part 2: Guidance for work

Standards on related subjects:

RB/T 033-2020 — Guidance on verification and validation of microbiological testing methods

YY/T 0506.1-2023 — Surgical drapes, gowns and clean air suits - Part 1: General requirements

YY 9706.246-2023 — Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

5 Classification and status

Chinese Standard Classification (CCS): A 00

Prefix YY/T: recommended standard.

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

Similar standards

GB/T 16733-1997|YY/T 1000.2-2005|GB/T 20003.1-2014|GB/T 24620-2022|GB/T 28222-2011|NB/T 10442-2020

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