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YY/T 0466.1-2009Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (English PDF)

医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 25, 2009

Implementation date

December 1, 2010

Scope

YY/T 0466.1-2009 is the English-translated version of 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求.

YY/T 0466.1-2009 is the Chinese standard "Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements".

Its scope clause reads: This part of YY 0466 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices.

It also lists symbols that satisfy the requirements of this part of YY 0466. This part of YY 0466 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally.

These symbols may be used on the device itself or its package or in the associated documentation. Its clauses include terms and definitions.

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Document preview — YY/T 0466.1-2009

National Standard of the People's Republic of China

Replacing
YY 0466-2003

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

Contents

  • Foreword II
  • Introduction III
  • 1 Scope
  • 2 Normative References
  • 3 Terms and Definitions
  • 4 General Requirements
  • 4.1 Proposal for symbols for adoption
  • 4.2 Requirements for usage
  • 5 Symbols
  • Appendix A (Informative) Examples
  • Appendix B (Normative) Proposal for the Adoption of a Symbol into YY/T
  • Appendix C (Normative) Basic Pattern for Symbol Design
  • Appendix D (Informative) Use of the General Prohibition Symbol
  • Bibliography

1 Scope

This part of YY 0466 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of YY 0466.

This part of YY 0466 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

2 Normative References

The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0466. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.

GB/T 7408 Data elements and interchange formats — Information interchange — Representation of dates and times (ISO 8601, IDT)

GB/T 23371.3 Basic principles for graphical symbols for use on equipment — Part 3: Guidelines for the application of graphical symbols (IEC 80416-3, IDT)

IEC 80416-1:2001 Basic principles for graphical symbols for use on equipment — Part 1: Creation of symbol originals

ISO 80416-2 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows

ISO 80416-4 Basic principles for graphical symbols for use on equipment — Part 4: Guidelines for the adaptation of graphical symbols for use on screens and displays (icons)

3 Terms and Definitions

For the purposes of this document, the following terms and definitions apply.

3.1 Characteristic information

Mental representation of a property or properties of an object or set of objects.

3.2 Description

Normative text attached to the representation of the symbol original, which defines the purpose, the application and the use of the symbol original.

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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.

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Editions of YY/T 0466.1

EditionTitleRevisionStatus
YY/T 0466.1-2009Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirementscurrent editionCurrent
YY 0466-2003Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirementsprevious editionSuperseded

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