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YY/T 0466.1-2016

Chinese Standard: 'YY/T 0466.1-2016'
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Detail Information of YY/T 0466.1-2016; YY/T0466.1-2016
Description (Translated English): Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C37; C30
Classification of International Standard: 01.080.20; 11.040.01
Word Count Estimation: 28,277
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Older Standard (superseded by this standard): YY/T 0466.1-2009
Quoted Standard: ISO 7000; ISO 8601; ISO 14971; ISO 15223-2
Adopted Standard: ISO 15223-1-2012, IDT
Drafting Organization: Beijing Guoya Huaguang Certification Co., Ltd
Administrative Organization: National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221)
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Proposing organization: State Administration of Food and Drug Administration
Issuing agency(ies): State Administration of Food and Drug Administration
Summary: This standard specifies the requirements for symbols for medical device labeling, which conveys information on the safe and efficient use of medical devices and lists the symbols that meet the requirements of this standard. This standard applies to the use of symbols on a wide range of medical devices that are sold worldwide and therefore need to meet different regulatory requirements. These symbols can be used on medical devices, on device packaging or in related documents. The requirements of this standard are not intended for use in the symbols specified in other standards.

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
医疗器械 用于医疗器械标签, 标记和提供信息的符号
第 1部分. 通用要求
(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 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
Related standard:   YY/T 0466.2-2015  YY/T 0468-2015
   
 
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