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YY/T 1960-2025: Medical devices - Information to be supplied by the manufacturer
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1960-2025
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01
CCS C 30
Medical devices - Information to be supplied by the
manufacturer
(ISO 20417.2021, MOD)
Issued on: JUNE 18, 2025
Implemented on: JULY 01, 2026
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
Introduction... 6
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 8
4 General... 18
5 Proposed information elements... 19
5.1 Units of measurement... 19
5.2 Graphical information... 20
5.3 Language and country identifiers... 20
5.4 Date... 21
5.5 Detailed address... 21
5.6 Catalogue name... 22
5.7 Model number... 22
5.8 Catalogue number... 22
5.9 Production control... 23
5.10 UDI... 23
5.11 Use/reuse type... 23
5.12 Sterility... 24
6 Requirements for accompanying information... 24
6.1 Requirements for information provided on labels... 24
6.2 Labeling requirements for detachable components of medical devices or accessories
... 33
6.3 Label clearly legible... 34
6.4 Durability of marking... 34
6.5 Information provided on the packaging... 35
6.6 Information requirements in the instruction for use and technical description... 40
7 Other information to be provided with the medical device or accessories... 53
7.1 Importer... 53
7.2 Distributor... 53
7.3 Translation... 54
7.4 Identification information required by regulations... 54
Annex A (Informative) Specific guidelines and instructions... 56
A.1 General guidelines... 56
A.2 General... 56
Medical devices - Information to be supplied by the
manufacturer
1 Scope
This document specifies the requirements for information to be supplied by the
manufacturer of medical devices or accessories. This document includes generally
applicable requirements for the marking and labeling of medical devices or accessories
on their own and their packaging, as well as the identification and accompanying
information of medical devices or accessories. This document does not specify the
method of providing information.
The requirements of medical device product standards or group standards take
precedence over the requirements of this document.
Note 1.See Annex A, A.2 for the guidelines or instructions for this clause.
Note 2.The requirements for the labeling, marking, and accompanying
documentation of medical devices or accessories - as imposed by certain
regulatory authorities with jurisdiction - may differ from those in this
document.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
GB/T 2659.1, Codes for the representation of names of countries and their subdivisions
- Part 1.Country code (GB/T 2659.1-2022, ISO 3166-1.2020, MOD)
GB/T2893.1, Graphical symbols - Safety colours and safety signs - Part 1.Design
principles for safety signs and safety markings (GB/T 2893.1-2013, ISO 3864-1.2011,
MOD)
GB/T 7408.1, Date and time - Representations for information interchange - Part 1.
Basic rules (ISO 8601.2019, IDT)
GB/T 42061-2022, Medical devices - Quality management systems - Requirements for
regulatory purposes (ISO 13458.2016, IDT)
GB/T 42062-2022, Medical devices - Application of risk management to medical
devices (ISO 14971.2019, IDT)
YY/T 0466.1-2023, Medical devices - Symbols to be used with information to be
supplied by the manufacturer - Part 1.General requirements (ISO 15223-1.2021, IDT)
ISO 7000, Graphical symbols for use on equipment - Registered symbols
ISO 7010.2019, Graphical symbols - Safety colours and safety signs - Registered safety
signs
ISO 80000-1, Quantities and units - Part 1.General
IEC 60417 (database), Graphical symbols for use on equipment
IEC 62366-1.2015, Medical devices - Part 1.Application of usability engineering to
medical devices
3 Terms and definitions
For the purpose of this document, terms and definitions given in GB/T 42061-2022,
GB/T 42062-2022 and IEC 62366-1.2015, as well as the following apply.
3.1
accessory
An article specifically designed by the manufacturer for use with one or more medical
devices, enabling or assisting in the use of those medical devices as intended.
Note 1.An accessory is typically a consumable or an individual item used with one or
more medical devices.
Note 2.Some regulatory authorities with jurisdiction consider accessory to be a
medical device.
Note 3.Some regulatory authorities with jurisdiction have a different definition for
accessory.
Note 4.The definition of accessory in GB 9706.1 is as follows.
An accessory refer to the additional part used together with the equipment, so
as to.
-- achieve intended use;
-- make the equipment suitable for certain specific purposes;
symbol
Illustrations displayed on medical device labels and/or related documents for conveying
characteristic information, not requiring the information provider or recipient to have
language knowledge of a specific country or ethnicity.
Note. Symbols may be abstract patterns or illustrations, or common object graphics,
including letter or number characters with a good reason.
[Source. YY/T 0466.1-2023, 3.18]
3.30
technical description
Part of the accompanying information for guiding responsible parties and service
personnel, which is essential for preparing for the initial use and safe use, maintenance
or repair of medical devices or accessories, as well as for their processing, transport and
storage throughout their expected lifetime.
Note 1.The technical description may be included in the instruction for use.
Note 2.See Figure 1 as an example.
3.31
UDI data carrier
unique device identifier data carrier
Data media for storing or transmitting the unique identifier of a medical device.
Note. UDI data carrier may include one-dimensional/linear barcodes, two-
dimensional/matrix barcodes, radio frequency identification (RFID), etc.
[Source. YY/T 1681-2019, 4.1, modified]
4 General
The information supplied by the manufacturer typically takes the following aspects into
consideration.
a) The risk management process in GB/T 42062-2022 and the usability
engineering process in IEC 62366-1.2015 should be used to determine the
information (including information for safety) provided in the information
supplied by the manufacturer.
Note 1.Medical device-specific standards may require manufacturers to provide
additional information.
b) If this document specifies a particular version of a normative reference, the
manufacturer may substitute it with a newer version, provided that the
manufacturer can demonstrate that the residual risks arising from the
substitution remain acceptable and are comparable to those arising from the
application of the particular version of the normative reference.
c) The information supplied by the manufacturer shall be in a language
appropriate for the intended users.
Note 2.Regulatory authorities with jurisdiction may impose requirements on the
language chosen for the information supplied by the manufacturer.
d) The accompanying information shall specify.
1) Any professional skills, training, and expertise required by the intended
user or responsible party, which are necessary to achieve the intended use
of the medical device;
2) If applicable, restrictions on the intended use environment of the medical
device.
e) Information supplied by the manufacturer shall be written and presented in
terms that are easy for the intended user to understand, taking into account
their education, training and any special needs where appropriate.
Note 3.Medical device-specific standards may require additional usability
requirements.
Check for compliance by reviewing the information supplied by the manufacturer.
5 Proposed information elements
5.1 Units of measurement
In the information supplied by the manufacturer, the units of measurement used.
a) The numerical display of parameters in the information supplied by the
manufacturer shall be expressed as follows.
1) the International System of Units (SI) as defined in ISO 80000-1;
2) any other unit required by relevant group standards or product standards;
or
3) any other unit established by clinical practice;
b) For the application of SI units, their multiples and certain other units, ISO
80000-1 shall apply.
Check for compliance by reviewing the information supplied by the manufacturer.
5.2 Graphical information
In the information supplied by the manufacturer, the graphical information used.
a) Any graphical information that replaces the text, such as pictograms, symbols,
safety signs, and safety-related colorings, used in information supplied by the
manufacturer, shall be explained in the accompanying documentation;
Note. Regulatory authorities with jurisdiction may impose other requirements.
b) The symbols used in the information supplied by the manufacturer should be
found in the following standards.
1) ISO 7000 (database);
2) ISO 7010;
3) YY/T 0466.1;
4) IEC 60417 (database);
5) IEC/TR 60878.2015; or
6) If applicable.
ⅰ) relevant product standards; or
ⅱ) relevant group standards;
c) Symbols should be used in the information supplied by the manufacturer.
Check for compliance by reviewing the information supplied by the manufacturer,
instruction for use, and e-documentation.
5.3 Language and country identifiers
5.3.1 Language identifier
In the information supplied by the manufacturer where multiple languages are used, the
language names used.
a) should have a clear connection with the language used; and
b) may be identified in the following ways.
1) plain text name of the language; or
2) language codes given in the following standards.
ⅰ) GB/T 4880.1;
ⅱ) GB/T 4880.2; or
ⅲ) GB/T4880.3.
Check for compliance by reviewing the information supplied by the manufacturer.
5.3.2 Country identifier
If the information supplied by the manufacturer includes details of contacting multiple
countries or regions, the countries or regions shall be identified in the following way.
a) country or region code specified in GB/T 2659.1; or
b) the country's plain text name in its language.
Check for compliance by reviewing the information supplied by the manufacturer.
5.4 Date
In the information supplied by the manufacturer, apart from the text related to the UDI
data carrier, any human-readable dates shall be represented in any of the following
formats in accordance with GB/T 7408.
Note. Regulatory authorities with jurisdiction may impose other requirements.
a) Year (××××)-Month (××)-Day (××);
b) Year (××××) Month (××) Day (××);
c) Year (××××)-Month (××); or
d) Year (××××).
Check for compliance by reviewing the information supplied by the manufacturer.
5.5 Detailed address
In the information supplied by the manufacturer, the detailed address used.
a) If this document refers to a detailed address, the address shall include the
following elements that are available in the address system for the actual
location of the relevant entity (manufacturer, distributor, importer, or
authorized representative).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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