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YY/T 0466.1-2023 English PDF (YYT0466.1-2023)

YY/T 0466.1-2023 English PDF (YYT0466.1-2023)

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YY/T 0466.1-2023: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements

This document specifies symbols, which are used to express information provided on medical devices. This document applies to symbols used on various medical devices, that are available worldwide and need to comply with different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in accompanying information. The requirements of this document are not expected to apply to symbols, which are specified in other standards.
YY/T 0466.1-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 01.080.20; 11.040.01
CCS C 37
Replacing YY/T 0466.1-2016
Medical devices - Symbols to be used with information to be
supplied by the manufacturer - Part 1: General
requirements
(ISO 15223-1:2021, MOD)
ISSUED ON: SEPTEMBER 05, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 7
1 Scope ... 9
2 Normative references ... 9
3 Terms and definitions ... 10
4 General requirements ... 17
4.1 Symbols to be adopted in the future ... 17
4.2 How to use... 17
4.3 Other symbols ... 18
5 Symbols ... 18
Appendix A (Informative) Guidelines and examples for using symbols, including multiple symbols ... 41
Appendix B (Informative) Use of general prohibition symbols and negative symbols ... 48
References ... 49
Medical devices - Symbols to be used with information to be
supplied by the manufacturer - Part 1: General
requirements
1 Scope
This document specifies symbols, which are used to express information provided on medical devices.
This document applies to symbols used on various medical devices, that are available worldwide and need to comply with different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in accompanying information. The requirements of this document are not expected to apply to symbols, which are specified in other standards.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, for dated reference documents, only the version corresponding to the date applies to this document; for undated reference documents, the latest version (including all amendments) applies to this document.
GB/T 2659.1 Codes for the representation of names of countries and their subdivisions - Part 1: Country code (ISO 3166-1:2020, MOD)
YY/T 0466.2 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 2: Symbol development, selection and validation (YY/T 0466.2-2015, ISO 15223-2:2010, IDT)
ISO 8601-1 Date and time - Representations for information interchange - Part 1: Basic rules)
Note: GB/T 7408-2005 Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601:2000, IDT)
ISO 8601-2 Date and time - Representations for information interchange - Part 2: Extensions
3.4
Distributor
A natural or legal person in the supply chain who, other than the manufacturer or importer, facilitates users to obtain medical devices or accessories on their own behalf.
Note 1: Multiple distributors may be involved in the supply chain.
Note 2: Persons involved in activities such as storage and transportation on behalf of manufacturers, importers or distributors in the supply chain are not distributors. [Source: ISO 20417:2021, 3.5]
3.5
Importer
The first natural or legal person in the supply chain, who makes a medical device manufactured in another country or jurisdiction marketable in the country or jurisdiction where it is to be marketed.
[Source: GB/T 42061-2022, 3.7]
3.6
Information supplied by the manufacturer
Information related to the identification and use of medical devices or accessories, provided in any form, is intended to ensure the safe and effective use of medical devices or accessories.
Note 1: Information provided by the manufacturer includes electronic documents. Note 2: The information provided by the manufacturer does not include shipping documents and promotional materials. However, some regulatory authorities with jurisdiction (as defined in 3.1 of ISO 16142-1:2016) may consider such supplementary information to be information provided by the manufacturer.
Note 3: The main purpose of the information provided by the manufacturer is to identify the medical device and its manufacturer, AND to provide users or other relevant persons with basic information on the safety, performance, appropriate use of the medical device. Note 4: See Figure 1.
Note 5: Guidance and instructions related to the information provided by the manufacturer are found in Appendix A of ISO 20417:2021.
Lot code
A combination of letters or numbers associated with a single lot or lot in production control.
[Source: ISO 20417:2021, 3.15]
3.10
Manufacturer
A natural or legal person in whose name a medical device intended to be available is manufactured and who is responsible for the design and/or manufacture of the medical device, whether the design and/or manufacture of the medical device is carried out by that natural or legal person or by others on his or her behalf. Note 1: This ?€?natural or legal person?€? has the ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements in the country or jurisdiction, in which the medical device is intended to be available or sold, unless the regulatory authority (RA) in that jurisdiction expressly imposes liability on another natural or legal person. Note 2: The manufacturer's responsibilities are described in other Global Harmonization Organization (GHTF) guidance documents. These responsibilities include meeting pre- marketing requirements and post-marketing requirements, such as adverse event reporting and corrective action notifications.
Note 3: ?€?Design and/or manufacture?€? includes the specification, production, manufacture, assembly, processing, packaging, repackaging, labeling, relabeling, sterilization, installation or remanufacturing of medical devices; or combining multiple devices, which may also include other products, for medical purposes.
Note 4: Any natural or legal person, who assembles or modifies a medical device provided by others for an individual patient, in accordance with the instructions for use, is not a manufacturer, if the assembly or modification does not change the intended use of the medical device.
Note 5: Any natural or legal person, who does not change the intended use of a medical device or modify a medical device in the name of the original manufacturer, meanwhile makes the device available for use in its name, is considered to be the manufacturer of the modified medical device.
Note 6: Authorized representatives, distributors or importers, who only add their address and contact information to the medical device or packaging, without covering or changing the existing marking, are not considered manufacturers.
Note 7: For accessories that are subject to medical device supervision, the natural or legal person responsible for the design and/or manufacture of the accessory is considered the manufacturer.
[Source: GB/T 42062-2022, 3.9]
3.11
Marking
Information in text or graphic format, that is permanently affixed, printed, etched (or equivalent) to a medical device or accessory.
Note 1: The term "marking" is used to indicate the corresponding action. Note 2: The marking is different from the "ontology direct identification", which is usually described in Unique Medical Device Identification (UDI) standards and regulations. UDI "Ontology direct identification" is an indication.
Note 3: See Figure 1.
[Source: ISO 20417:2021, 3.16]
3.12
Model number
Model
Letters, numbers, or a combination of both assigned by the manufacturer to function or type, to distinguish a specific medical device, accessory, or family of medical devices.
Note: See Figure 2 in ISO 20417:2021.
[Source: ISO 20417:2021, 3.17, modified]
3.13
Risk
The combination of the probability of an injury occurring and the severity of that injury.
[Source: GB/T 42062-2022, 3.18]
3.14
Serial number
A combination of letters or numbers selected during the manufacturer's production Symbol
A pictorial representation displayed on a medical device label and/or related documentation, that conveys characteristic information without requiring the information provider or recipient to know the language of a particular country or nation.
Note: Symbols may be abstract patterns or illustrations, or use common object graphics, including alphanumeric characters with a well-reasoned description.
[Source: ISO 20417:2021, 3.29]
4 General requirements
4.1 Symbols to be adopted in the future
The symbols proposed for use in this document comply with the following requirements: a) Symbols adopted in the future shall be confirmed according to YY/T 0466.2, except for the symbols as registered in ISO 7000, ISO 7010 or IEC 60417; b) Any symbol shall apply to a range of medical devices and have global or regional applicability.
4.2 How to use
The symbols used in this document are as follows:
a) When identification requires the use of symbols as an appropriate method for conveying necessary information for the correct use of a medical device, the symbols given in Table 1 may be marked on the medical device, displayed on its packaging or in information provided by the manufacturer;
Note 1: ISO and IEC jointly maintain an online database of graphical symbols for equipment (https://www.iso.org/obp/ui/#home). This database covers all graphical symbols of ISO 7000, ISO 7001, IEC 60417. In this database, each graphic symbol is displayed and identified by a reference number and title. Graphical symbols are obtained in different formats (such as AI, DWG, EPS); when applicable, some additional data are provided. b) The manufacturer shall determine the appropriate dimensions of the symbol, so that the symbol is legible for its intended function;
Note 2: This document does not specify the color or minimum size of the symbols in Table 1, nor the relative size of the symbols and the relative size of the information they display. Note 3: For guidance on the application of graphical symbols, see IEC 80416- 3:2002+A1:2011.
Note 4: See Appendix B for guidelines on the use of general prohibited symbols and negative symbols.
c) All dates and times appearing with symbols shall use the conventions given in ISO 8601-1 and ISO 8601-2.
4.3 Other symbols
Other standards specify additional symbols, that are applicable to specific varieties or types of medical devices or that are applicable to specific situations. References provide examples of the sources of these additional symbols.
5 Symbols
Use of the symbols given in this document follows the following requirements: a) Where appropriate, the necessary information for the correct use of the medical device shall be marked on the medical device, on its packaging or in
accompanying information, by using the corresponding symbols given in Table 1; b) The manufacturer may use any appropriate symbol;
Note 1: For ease of use, Table 1 is grouped by symbol category. As far as usage is concerned, the categories of symbol groupings have no meaning. The order in which symbols appear and the categories they are in have no priority. See Appendix A for examples of symbol usage.
Note 2: Each symbol in the ISO and IEC symbol database
(https://www.iso.org/obp/ui/#home) has a reference number and registration date. This information is given in the last column of Table 1.

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