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
YY/T 0466.1-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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 comb...