YY/T 0466.1-2023 PDF English
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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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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 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/YYT0466.1-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
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
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 1.General requirements;
- 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
5.1.1; 5.1.1 of the 2016 edition);
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);
g) CHANGE the requirements of symbol 5.1.3 in Table 1, deleting the note, adding
the usage restrictions (see 5.1.3; 5.1.3 of the 2016 edition);
h) CHANGE the title "lot code" of symbol 5.1.5 in Table 1 into "lot number" (see
5.1.5; 5.1.5 of the 2016 edition);
i) CHANGE the title "serial number" of symbol 5.1.7 in Table 1 into "serial No."
(see 5.1.7; 5.1.7 of the 2016 edition);
j) CHANGE the title "non-aseptic" in symbol 5.2.7 in Table 1 into "non-sterile" (see
5.2.7; 5.2.7 in the 2016 edition);
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);
l) CHANGE the title "sterile liquid path" in symbol 5.2.9 in Table 1 into "sterile fluid
path" (see 5.2.9; 5.2.9 in the 2016 edition);
m) CHANGE the title of symbol 5.3.3 in Table 1 "Avoid heat and radiation" into
"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);
p) CHANGE the description, requirements, usage restrictions of the title in symbol
5.4.4 "Warning" in Table 1, deleting the note (see 5.4.4; 5.4.4 of the 2016 edition);
q) CHANGE the title "sampling location" of symbol 5.6.1 in Table 1 into "sample
location" (see 5.6.2; 5.6.2 of the 2016 edition);
r) CHANGE the title "liquid path" of symbol 5.6.2 in Table 1 into "fluid path" (see
5.6.2; 5.6.2 of the 2016 edition);
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
consistency with GB/T 42061-2022;
- DELETE the term "medical device" (see 3.12 of ISO 15223-1.2021), because the
"medical device" is defined in medical device regulations and standards, so it is not
repeated in this document;
- CHANGE the expression of information about EU regulations in the full text, to
comply with China's regulatory requirements.
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).
This standard replaces the standard previously issued as follows.
- It was first released in 2003 as YY 0466-2003;
- It was revised for the first time into a sub-part standard in 2009; this document
corresponds to YY/T 0466.1-2009;
- It was revised for the second time in 2016;
- This is the third revision.
1 Scope
This document specifies symbols, which are used to express information provided on
medical devices.
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)
GB/T 7408-2005 Data elements and interchange formats - Information
interchange - Representation of dates and times (ISO 8601.2000, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Accompanying information
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.
3.2
Catalogue number
A value given by the manufacturer, to identify a specific medical device or accessory
with respect to shape/configuration, function and process.
4 General requirements
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;
Other standards specify additional symbols, that are applicable to specific varieties or
types of medical devices or that are applicable to specific situations.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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