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

Foreword

This document was drafted in accordance with the provisions of GB/T 1.1-2020 "Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents".

This document is Part 1 of YY/T 0466 "Medical devices - Symbols to be used with information to be supplied by the manufacturer". YY/T0466 has released the following parts:

- Part 2: Symbol development, selection and validation.

This document replaces 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". Compared with YY/T 0466.1-2016, except for structural adjustments and editorial changes, the main technical changes are as follows:

a) ADD the terms "accompanying information" (see 3.1), "catalogue number" (see 3.2), "distributor" (see 3.4), "importer" (see 3.5), "information supplied by the manufacturer" (see 3.6), "instructions for use" (see 3.7), "lot number" (see 3.9), "manufacturer" (see 3.10), "marking" (see 3.11), "model number" (see 3.12), "risk" (see 3.13), "serial number" (see 3.14), "single patient multiple use" (see 3.15), "single use" (see 3.16), "sterile" (see 3.17), "symbol" (see 3.18);

b) DELETE the terms "characteristic information" (see 3.1 of the 2016 edition), "marking" (see 3.4 of the 2016 edition), "symbols used for marking medical devices" (see 3.5 of the 2016 edition), "title" (see 3.6 of the 2016 edition);

c) CHANGE the definition of the term "label" (see 3.8, 3.3 of the 2016 version);

d) In Table 1, ADD 19 symbols confirmed in accordance with YY/T 0466.2 and 6 registered symbols in ISO 7000, ISO 7001 or IEC 60417. DELETE the column of "Additional requirements". CHANGE the header of the last column "ISO 7000 registration number" into "ISO/IEC symbol number and registration date". ADD the registration date to all registered symbols (see Table 1; Table 1 of the 2016 edition);

e) CHANGE the description, requirements, notes of symbol 5.1.1 in Table 1 (see f) CHANGE the title of symbol 5.1.2 in Table 1 "EU authorized representative" into "European community/EU authorized representative", changing the requirements and notes (see 5.1.2; 5.1.2 in the 2016 edition);

h) CHANGE the title "lot code" of symbol 5.1.5 in Table 1 into "lot number" (see i) CHANGE the title "serial number" of symbol 5.1.7 in Table 1 into "serial No."

j) CHANGE the title "non-aseptic" in symbol 5.2.7 in Table 1 into "non-sterile" (see k) CHANGE the title of symbol 5.2.8 in Table 1 "Do not use if the packaging is damaged" into "Do not use if the packaging is damaged and consult the instructions for use", changing the instructions and notes (see 5.2.8; 5.2.8 of the 2016 edition);

"Avoid sun exposure and radiation", changing the note (see 5.3.3; 5.3.3 of the 2016 edition);

n) CHANGE the title of symbol 5.4.2 in Table 1 "No secondary use" into "No reuse" (see 5.4.2; 5.4.2 of the 2016 edition);

o) CHANGE the symbol 5.4.3 "Check the instructions for use" in Table 1 into "Check the instructions for use, electronic instructions for use" (see 5.4.3; 5.4.3 of the 2016 edition);

r) CHANGE the title "liquid path" of symbol 5.6.2 in Table 1 into "fluid path" (see s) CHANGE the title "liquid filter pore size" of symbol 5.6.5 in Table 1 into "liquid filter with pore size" (see 5.6.5; 5.6.5 of the 2016 edition);

t) ADD examples of using symbols to Appendix A.

This document modifies and adopts ISO 15223-1:2021 "Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements".

The technical differences between this document and ISO 15223-1:2021, as well as their reasons, are as follows:

- USE the normative reference GB/T 2659.1 to replaced ISO 3166-1, to adapt to China's technical conditions, thereby increasing operability;

- USE the normative reference YY/T 0466.2 to replaced ISO 15223-2, to adapt to China's technical conditions, thereby increasing operability;

- CHANGE the definition and origin of the term "importer" (see 3.5), to keep "medical device" is defined in medical device regulations and standards, so it is not repeated in this document;

Please note that some contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document shall be under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221).

Drafting organizations of this document: Beijing Guoyi Huaguang Certification Co., Ltd., China Institute for Food and Drug Control, Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Wandong Medical Technology Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Shanghai MicroPort Medical Devices (Group) Co., Ltd., Shandong Provincial Food and Drug Evaluation and Inspection Center, Shandong Ande Medical Supplies Co., Ltd., DuPont (China) R&D Management Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.

The main drafters of this document: Wang Meiying, Wang Tingting, Zheng Jia, Zhang Boxing, Xu Qiang, Liu Lina, Li Ran, Sun Haipeng, Liang Wanjie, Qian Jun, Hong Mei, Chang Jia, Wu Juan, Liu Rongmin, Li Xin, Shao Yubo, Li Zhaohui.

- It was revised for the first time into a sub-part standard in 2009; this document

- It was revised for the second time in 2016;

- This is the third revision.

Introduction

Medical device manufacturers and other parties in the supply chain are required to provide specific information on the medical device, on its packaging or in accompanying information. For simplicity and to avoid text translation, this information is provided by symbols with specific meanings. This document does not specify the information that needs to be provided, only the internationally recognized symbols used to provide this specific information are specified.

The symbols included in this document have been published in ISO 7000, ISO 7001, IEC 60417, OR have gone through a formal symbol validation process.

This document is intended for use by medical device manufacturers selling products in countries with specific language requirements. These symbols achieve a consistent description of the information. This document may also be used by customers or endusers of medical devices, who obtain medical devices from many sources and may have varying language abilities.

YY/T 0466 "Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied" is divided into two parts.

- Part 1: General requirements. The purpose is to propose requirements for the formulation and use of symbols that express medical device information, AND to provide internationally recognized symbols that meet the requirements.

- Part 2: Symbol development, selection and validation. The purpose is to formulate, select, and confirm the symbols to be included in YY/T 0466.1, to ensure that these symbols are easy to understand by the target group.

In this document, the following auxiliary verbs are used:

- "May/could" means possibility or ability;

- "Must" means external constraints that are not required by this document.

Information marked with "Note" is intended to assist in understanding or using this document. The "Note" used in Chapter 3 provides additional information that supplements the technical data and may contain provisions related to the use of terms.

Symbols added during the revision of this document are located at the end of the relevant parts of Table 1, to maintain the numbering of the original symbols and to facilitate the reference of the original symbols in other documents.

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.

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 Terms and definitions

The following terms and definitions apply to this document. Information accompanying or labeled on a medical device or accessory, that contains information for the user or person responsible for the installation, use, handling, maintenance, eventual decommissioning, disposal of the medical device or accessory, in particular regarding its safe use information. Note 1: The accompanying information is considered part of the medical device or accessory. Note 2: The accompanying information may include labels, markings, instructions for use, technical instructions, installation manuals, quick reference guides, etc. Note 3: The accompanying information is not necessarily a written or printed document, but may involve auditory, visual or tactile information and multiple media types (such as CD/DVD read-only discs, USB flash drives, websites). Note 5: Label may include information found on medical device packaging. Note 6: Electronic documents may include part or all of any or all types of information provided by the manufacturer. Note 7: Marketing information is also called promotional material. Note 8: Guidance and instructions related to the accompanying information are found in Appendix A of ISO 20417:2021. A value given by the manufacturer, to identify a specific medical device or accessory with respect to shape/configuration, function and process (i.e., differentiated manufacturing process required by the end user). Note 1: The catalogue number consists of letters or numbers or a combination of both. Note 2: The catalogue number shall not be confused with the "product code" or "original code classification" of the U.S. Food and Drug Administration (FDA). Note 3: A synonym for catalogue number is "reference number" or "renewal number". Normative text defining the purpose, application, use of symbols (3.18). 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. 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. 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. […]

4 General requirements

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;

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.