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YY/T 0466.1-2016Medical 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

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 0466.1-2016 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 0466.1-2016 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/T 0466 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

It also lists symbols that satisfy the requirements of this part of YY/T 0466. This part is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this part are not intended to apply to symbols specified in other standards. Its clauses include terms and definitions.

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Document preview — YY/T 0466.1-2016

National Standard of the People's Republic of China

Replacing: YY/T 0466.1-2009

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

Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
5.1 Manufacture
5.2 Sterility
5.3 Storage
5.4 Safe use
5.5 IVD-specific
5.6 Transfusion/infusion
5.7 Other
Annex A (Informative) Examples
Annex B (Informative) Use of general prohibition symbol and negation symbol
Bibliography

1 Scope

This part of YY/T 0466 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of YY/T 0466.

This part is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7000 Graphical symbols for use on equipment - Index and synopsis

ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times

ISO 14971 Medical devices - Application of risk management to medical devices

ISO 15223-2 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.

3.1 characteristic information

information that represents the property or properties of a symbol

3.2 description

normative text which defines the purpose, application and use of the symbol

Note: Adapted from GB/T 23371.1-2013, definition 3.2.

3.3 label

written, printed or graphic information provided upon the medical device itself

Note: Adapted from GHTF/SG1/N43:2005.

3.4 labelling

information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device or any of its containers or wrappers

Note 1: This information relates to the identification, technical description and use of the medical device, but excludes shipping documents.

Note 2: Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.

3.5

symbol used in medical device labelling graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

Note: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

Referenced standards

Cited by

Similar standards

YY 0466-2003|GB/T 29791.1-2013|GB/T 29791.2-2013|GB/T 29791.3-2013|GB/T 29791.4-2013|GB/T 29791.5-2013

Editions of YY/T 0466.1

Edition	Title	Revision	Status
YY/T 0466.1-2016	Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements	current edition	Current
YY/T 0466.1-2009	Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements	previous edition	Superseded

This page sells the current edition, YY/T 0466.1-2016. Earlier editions are listed for reference only.

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