YY/T 0466.1-2023 English PDF (YY/T0466.1-2023)

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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
YY/T 0466.1-2023. Medical device symbols for information provided by manufacturers Part 1. General requirements
ICS 01.080.20;11.040.01
CCSC37
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0466.1-2016
Medical device symbols used for information provided by manufacturers
Part 1.General requirements
manufacturer-Part 1.General requirements
Published on 2023-09-05
Implemented on 2025-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction III
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 General requirements 5
4.1 Future adopted symbols 5
4.2 How to use 5
4.3 Other symbols 5
5 symbols 6
Appendix A (Informative) Guidelines and examples for using symbols (including multiple symbols) 25
Appendix B (informative) Use of general prohibited symbols and negative symbols 31
Reference 32
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document is Part 1 of YY/T 0466 "Medical Device Symbols for Manufacturer to Provide Information". YY/T 0466 has been issued
The following parts have been published.
---Part 1.General requirements;
---Part 2.Formulation, selection and confirmation of symbols.
This document replaces YY/T 0466.1-2016 "Medical Device Symbols for Labeling, Marking and Providing Information for Medical Devices - Part 1
"General Requirements", compared with YY/T 0466.1-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) Added the terms "accompanying information" (see 3.1), "product number" (see 3.2), "dealer" (see 3.4), "importer" (see 3.5),
"Information provided by the manufacturer" (see 3.6), "Instructions for use" (see 3.7), "batch number" (see 3.9), "manufacturer" (see 3.10), "label
"Indication" (see 3.10), "Model" (see 3.12), "Risk" (see 3.13), "Serial Number" (see 3.14), "Multiple Use for a Single Patient" (see
3.15), "single use" (see 3.16), "sterile" (see 3.17), "symbol" (see 3.18);
b) The terms "characteristic information" (see 3.1 of the.2016 edition), "marking" (see 3.4 of the.2016 edition), "for medical device labeling" are deleted.
"Notation symbol" (see 3.5 of the.2016 edition), "title" (see 3.6 of the.2016 edition);
c) Changed the definition of the term "label" (see 3.8, 3.3 of the.2016 version);
d) Table 1 adds 19 symbols confirmed in accordance with YY/T 0466.2 and ISO 7000, ISO 7001 or IEC 60417
For the 6 registered symbols, the "Additional Requirements" column has been deleted, and the header "ISO 7000 Registration Number" in the last column has been changed to "ISO /
IEC symbol number and registration date", and added the registration date for all registered symbols (see Table 1, Table 1 of the.2016 version);
e) Changed the description, requirements and notes of symbol 5.1.1 in Table 1 (see 5.1.1, 5.1.1 of the.2016 version);
f) Changed the title of symbol 5.1.2 in Table 1 "EU Authorized Representative" to "European Community/EU Authorized Representative", and also changed the requirements
Summing annotations (see 5.1.2, 5.1.2 in the.2016 version);
g) Changed the requirements of symbol 5.1.3 in Table 1, deleted the note, and added usage restrictions (see 5.1.3, 5.1.3 of the.2016 version);
h) Changed the title "batch code" of symbol 5.1.5 in Table 1 to "batch number" (see 5.1.5, 5.1.5 of the.2016 version);
i) Changed the title "Serial Number" of symbol 5.1.7 in Table 1 to "Serial Number" (see 5.1.7, 5.1.7 of the.2016 version);
j) Changed the title "non-sterile" in symbol 5.2.7 in Table 1 to "non-sterile" (see 5.2.7, 5.2.7 in the.2016 version);
k) Changed the title of Symbol 5.2.8 in Table 1 "Do not use if the packaging is damaged" to "Do not use if the packaging is damaged and consult the instructions for use"
"Book", and changed the description and notes (see 5.2.8, 5.2.8 of the.2016 version);
l) Changed the title "sterile fluid path" in symbol 5.2.9 in Table 1 to "sterile fluid path" (see 5.2.9, 5.2.9 in the.2016 version);
m) Changed the title of symbol 5.3.3 in Table 1 "Afraid of Heat and Radiation" to "Afraid of Sun and Afraid of Radiation", and changed the note (see 5.3.3,.2016
version 5.3.3);
n) Changed the title of symbol 5.4.2 in Table 1 from "No secondary use" to "No reuse" (see 5.4.2, 5.4.2 of the.2016 version);
o) Changed the symbol 5.4.3 "Check the instructions for use" in Table 1 to "check the instructions for use, electronic instructions for use" (see 5.4.3,
2016 version of 5.4.3);
p) Changed the description, requirements and usage restrictions of the symbol 5.4.4 heading "Warning" in Table 1, and deleted the note (see 5.4.4,.2016
version 5.4.4);
q) Changed the title "sampling location" of symbol 5.6.1 in Table 1 to "sample location" (see 5.6.2, 5.6.2 of the.2016 version);
r) Changed the title "liquid path" of symbol 5.6.2 in Table 1 to "fluid path" (see 5.6.2, 5.6.2 of the.2016 version);
s) Changed the title "liquid filter pore size" of symbol 5.6.5 in Table 1 to "liquid filter with pore size" (see 5.6.5,
2016 version of 5.6.5);
t) Examples of using symbols have been added to Appendix A.
This document is modified to adopt ISO 15223-1.2021 "Symbols for medical devices used for information provided by manufacturers - Part 1.General requirements".
The technical differences between this document and ISO 15223-1.2021 and their reasons are as follows.
---Replaced ISO 3166-1 with normatively quoted GB/T 2659.1 to adapt to my country's technical conditions and increase operability;
---Replaced ISO 15223-2 with normatively quoted YY/T 0466.2 to adapt to my country's technical conditions and increase operability;
---Changed the definition and origin of the term "importer" (see 3.5) to coordinate with GB/T 42061-2022;
---Deleted the term "medical device" (see 3.12 of ISO 15223-1.2021), due to the definition of "medical device" in medical device regulations and standards.
"Machine" are all defined and will not be repeated in this document;
---Changed the expression of information about EU regulations in the full text to comply with my country's regulatory requirements.
Please note that some contents of this document may involve patents, and the issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221).
This document was drafted by. Beijing Guoyi Huaguang Certification Co., Ltd., China Institute of Food and Drug Control, Shenzhen Mindray Biomedical Electronics
Subsidiary Co., Ltd., Beijing Wandong Medical Technology Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Shanghai
MicroPort Medical Devices (Group) Co., Ltd., Shandong Food and Drug Evaluation and Inspection Center, Shandong Ande Medical Supplies Co., Ltd., DuPont
(China) R and 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.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2003 as YY 0466-2003;
---Revised for the first time in.2009 as a sub-part standard, this document corresponds to YY/T 0466.1-2009;
---Second revision 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.
Information, for simplicity and to avoid text translation, is provided by symbols with specific meanings. This document does not stipulate the information that needs to be provided
information, only internationally recognized symbols used to provide such 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 enable information to be
Lines of consistent description. This document may also be used by customers or end users of medical devices who obtain medical devices from many sources and may
There are different language abilities.
YY/T 0466 "Medical Device Symbols for Manufacturer to Provide Information" is divided into two parts.
---Part 1.General requirements. The purpose is to put forward requirements for the formulation and use of symbols that express medical device information and provide satisfactory
An internationally recognized symbol that meets the requirements.
---Part 2.Formulation, selection and confirmation of symbols. The purpose is to formulate and select symbols to be included in YY/T 0466.1
and validation processes to ensure that the symbols are easily understood by the target group.
In this document, the following auxiliary verbs are used.
---"Should" indicates requirements;
---"Yi" means suggestion;
---"Can" means allowed;
---"may/can" means possibility or ability;
---"Must" indicates external constraints that are not required by this document.
Information marked "Note" is intended to assist in understanding or using this document. The "Note" used in Chapter 3 provides additional information that complements
contains technical data and may contain provisions regarding the use of terms.
Symbols added during the revision of this document are placed at the end of the relevant parts of Table 1 to maintain the numbering of the original symbols and facilitate the use in other documents.
Reference the original symbols in the file.
Medical device symbols used for information provided by manufacturers
Part 1.General requirements
1 Scope
This document specifies symbols 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 be used in other standards
prescribed symbols.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 2659.1 Name codes of countries and regions in the world and their administrative divisions Part 1.Country and region codes (ISO 3166-1.
2020,MOD)
YY/T 0466.2 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 2.Symbol development and selection
Selection and confirmation (YY/T 0466.2-2015, ISO 15223-2.2010, IDT)
ISO 8601-1 Date and time information exchange representations Part 1.Basic rules (Dateandtime-Representations
Note. GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000, IDT)
ISO 8601-2 Date and time information exchange representations Part 2.Extensions (Dateandtime-Representations
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Information accompanying or marked on medical devices or accessories, the content of which includes instructions for users or those responsible for the installation, use, or installation of medical devices or accessories.
Information provided by persons handling, maintaining, ultimately decommissioning and disposing of, in particular regarding safe use.
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.Accompanying information is not necessarily a written or printed document, but may involve auditory, visual or tactile information and a variety of media types (such as CD/
DVD read-only disc, USB flash drive, website).
Note 4.See Figure 1.
Note 5.Labeling 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 accompanying information are found in Appendix A of ISO 20417.2021.