YY/T 0466.1-2016 (YY/T 0466.1-2023 Newer Version) PDF English
YY/T 0466.1-2016 (YY/T0466.1-2016, YYT 0466.1-2016, YYT0466.1-2016)
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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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| YY/T 0466.1-2016 | English | 145 |
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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 0466.1-2009 | English | 719 |
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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 0466-2003 | English | 140 |
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Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
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Newer version: YY/T 0466.1-2023 Standards related to (historical): YY/T 0466.1-2023
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YY/T 0466.1-2016: PDF in English (YYT 0466.1-2016) YY/T 0466.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 01.080.20;11.040.01
C 37
YY/T 0466.1-2016 / ISO 15223-1.2012
Replacing YY 0466.1-2009
Medical devices - Symbols to be used with
medical device labels, labelling and information
to be supplied - Part 1. General requirements
(ISO 15223-1.2012, IDT)
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 7
4 General requirements ... 9
4.1 Proposal of symbols for adoption ... 9
4.2 Requirements for usage ... 9
4.3 Other symbols ... 10
5 Symbols ... 10
5.1 Manufacture ... 11
5.2 Sterility ... 15
5.3 Storage ... 18
5.4 Safe use ... 20
5.5 IVD-specific ... 22
5.6 Transfusion/infusion ... 24
5.7 Other ... 26
Annex A (informative) Examples ... 27
Annex B (informative) Use of general prohibition symbol and negation symbol
... 31
Bibliography ... 32
Foreword
YY/T 0466 consists of the following 2 parts, under the general title “Medical devices -
Symbols to be used with medical device labels, labelling and information to be
supplied”.
- Part 1. General requirements;
- Part 2. Symbol development, selection and validation.
This Part is Part 1 of YY/T 0466.
This Part is drafted according to the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0466.1-2009 “Medical devices - Symbols to be used with
medical device labels, labelling and information to be supplied - Part 1. General
requirements”. Compared with YY 0466.1-2009, the main changes are as follows.
- MODIFY the introduction;
- MODIFY the scope;
- MODIFY the normative references;
- DELETE 4 terms and definitions, i.e. “iconic presentation”, “symbol concept”,
“symbol original” and “symbol presentation”;
- ADD 12 symbols in Table 1, i.e. “Manufacturer”, “Authorized representative in the
European Community”, “Sterile fluid path”, “Contains or presence of natural rubber
latex”, “Contains sufficient for < n> tests”, “For IVD performance evaluation only”,
“Sampling site, “Fluid path, “Non-pyrogenic, “Drops per millilitre, “Liquid filter with
pore size” and “One-way valve”;
- ADD the column content of description of symbol, requirements, informative notes,
restrictions of use and additional requirements;
- DELETE Annex B “Proposal of using symbols in YY/T 0466.1” and Annex C “Basic
pattern of symbol design”.
This Part uses the translation method to equivalently adopt ISO 15223-1.2012
“Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1. General requirements” (English version).
China’s national documents identical or equivalent to the International documents
normatively referenced in this Part are as follows.
- GB/T 16273.1-2008 Graphical symbols for use on equipment - Part 1. Common
symbols (ISO 7000.2004, NEQ);
- GB/T 7408-2005 Data elements and interchange formats - Information
interchange - Representation of dates and times (ISO 8601.2000, IDT);
- YY/T 0316-2016 Medical devices - Application of risk management to medical
devices (ISO 14971.2007, IDT);
- YY/T 0466.2-2015 Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 2. Symbol development,
selection and validation (ISO 15223-2.2010, IDT).
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuing organizations of this document shall not be
held responsible for identifying any or all such patent rights.
This Part is proposed by China Food and Drug Administration.
This Part is under the jurisdiction of National Technical Committee on Medical Device
Quality Management and General Requirements of Standardization Administration of
China (SAC/TC 221).
Drafting organization of this Part. Beijing Guo Guang Certification of Medical Devices
Co., Ltd.
Main drafters of this Part. Mi Lanying, Zheng Yihan, Chen Zhigang.
The previous editions of the standard replaced by this Part are as follows.
- YY 0466-2003, YY/T 0466.1-2009.
Bibliography
[1] ISO 3864-1 Graphical symbols - Safety colours and safety signs - Part 1. Design
principles for safety signs and safety markings
[2] GB/T 16273.1-1996 Graphical symbols for use on equipment - Index and synopsis
(GB/T 16273.1-1996, ISO 7000.19891), IDT)
[3] ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety
signs
[4] ISO/TR 7239 Development and principles for application of public information
symbols2)
[5] ISO 15225 Medical devices - Quality management - Medical device nomenclature
data structure
[6] ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use3)
[7] ISO 18113-3 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional
use4)
[8] ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 4. In vitro diagnostic reagents for self-testing5)
[9] ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing6)
[10] ISO 80416-2 Basic principles for graphical symbols for use on equipment - Part 2.
Form and use of arrows
[11] ISO/IEC 13251 Collection of graphical symbols for office equipment
[12] IEC 60417 ISO 7000-DB Graphical symbols for use on equipment
1) Withdrawn. The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also
available online in the ISO webstore. For more information, go to
2) Withdrawn.
3) Cancels and replaces EN 375.2001.
4) Cancels and replaces EN 591.2001.
5) Cancels and replaces EN 376.2002.
6) Cancels and replaces EN 592.2002.
[13] IEC/TR 60878 Graphical symbols for electrical equipment in medical practice
[14] YY/T 1474-2016 Medical devices - Application of usability engineering to medical
devices (YY/T 1474-2016, IEC 62366.2007, IDT)
[15] GB/T 23371.1-2013 Basic principles for graphical symbols for use on equipment
- Part 1. Creation of graphical symbols for registration (GB/T 23371.1-2013, IEC
80416-1.2008, IDT)
[16] GB/T 23371.3-2009 Basic principles for graphical symbols for use on equipment
- Part 3. Guidelines for the application of graphical symbols (GB/T 23371.3-2009,
IEC 80416-3.2002, IDT)
[17] YY/T 0615.1-2007 Sterilization of medical devices - Requirements for medical
devices to be designated “STERILE” - Part 1. Requirements for terminally
sterilized medical devices (YY/T 0615.1-2007, EN 556-1.2001, IDT)
[18] EN 980.2008 Symbols for use in the labelling of medical devices
[19] EN 1041 Information supplied by the manufacturer of medical devices
[20] GHTF/SG1/N43.2005 Labelling for Medical Devices Available at.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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