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Standard ID | YY/T 0466.1-2023 (YY/T0466.1-2023) | Description (Translated English) | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C37 | Classification of International Standard | 01.080.20; 11.040.01 | Word Count Estimation | 40,462 | Date of Issue | 2023-09-05 | Date of Implementation | 2025-09-15 | Older Standard (superseded by this standard) | YY/T 0466.1-2016 | Drafting Organization | Beijing Guoyi Huaguang Certification Co., Ltd., China Institute of Food and Drug Control, Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Wandong Medical Technology Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Shanghai Minimally Invasive Medical Equipment (Group) Co., Ltd., Shandong Food and Drug Evaluation and Inspection Center, Shandong Ande Medical Products Co., Ltd., DuPont (China) R&D Management Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd. | Administrative Organization | National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies symbols used to express information provided on medical devices. This standard applies to symbols used on a variety of medical devices available worldwide that 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 specified in other standards. | Standard ID | 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| Word Count Estimation | 28,219 | Date of Issue | 2016-01-26 | Date of Implementation | 2017-01-01 | Older Standard (superseded by this standard) | YY/T 0466.1-2009 | Quoted Standard | ISO 7000; ISO 8601; ISO 14971; ISO 15223-2 | Adopted Standard | ISO 15223-1-2012, IDT | Drafting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. | Standard ID | YY/T 0466.1-2009 (YY/T0466.1-2009) | 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 | Classification of International Standard | 01.080.20; 11.040.01 | Word Count Estimation | 18,147 | Date of Issue | 2009-11-25 | Date of Implementation | 2010-12-01 | Older Standard (superseded by this standard) | YY 0466-2003 | Quoted Standard | GB/T 7408; GB/T 23371.3; IEC 80416-1-2001; ISO 80416-2; ISO 80416-4 | Adopted Standard | ISO 15223-1-2007, IDT | Drafting Organization | Medical Device Quality Management and General Requirements Standardization Technical Committee | Administrative Organization | National Standardization Technical Committee of Medical Device Quality Management and General Requirements | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | Proposing organization | State Food and Drug Administration Medical Device Division | Issuing agency(ies) | China Food and Drug Administration | Summary | This standard provides for the expression of safe and effective medical devices making use of information symbols and use requirements are also listed to meet YY/T 0466 requirements of this part of the sign. YY/T 0466 applies only to this part of the global sales of a wide range of medical equipment symbols. These symbols can be used in equipment or packaging or accompanying documents. |
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 combination of both assigned by the manufacturer to function
or type, to distinguish a specific medical device, accessory, or family of medical
devices.
Note: See Figure 2 in ISO 20417:2021.
[Source: ISO 20417:2021, 3.17, modified]
3.13
Risk
The combination of the probability of an injury occurring and the severity of that
injury.
[Source: GB/T 42062-2022, 3.18]
3.14
Serial number
A combination of letters or numbers selected during the manufacturer's production
Symbol
A pictorial representation displayed on a medical device label and/or related
documentation, that conveys characteristic information without requiring the
information provider or recipient to know the language of a particular country or
nation.
Note: Symbols may be abstract patterns or illustrations, or use common object graphics,
including alphanumeric characters with a well-reasoned description.
[Source: ISO 20417:2021, 3.29]
4 General requirements
4.1 Symbols to be adopted in the future
The symbols proposed for use in this document comply with the following requirements:
a) Symbols adopted in the future shall be confirmed according to YY/T 0466.2,
except for the symbols as registered in ISO 7000, ISO 7010 or IEC 60417;
b) Any symbol shall apply to a range of medical devices and have global or regional
applicability.
4.2 How to use
The symbols used in this document are as follows:
a) 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;
Note 1: ISO and IEC jointly maintain an online database of graphical symbols for equipment
(https://www.iso.org/obp/ui/#home). This database covers all graphical symbols of ISO
7000, ISO 7001, IEC 60417. In this database, each graphic symbol is displayed and
identified by a reference number and title. Graphical symbols are obtained in different
formats (such as AI, DWG, EPS); when applicable, some additional data are provided.
b) The manufacturer shall determine the appropriate dimensions of the symbol, so
that the symbol is legible for its intended function;
Note 2: This document does not specify the color or minimum size of the symbols in Table
1, nor the relative size of the symbols and the relative size of the information they display.
Note 3: For guidance on the application of graphical symbols, see IEC 80416-
3:2002+A1:2011.
Note 4: See Appendix B for guidelines on the use of general prohibited symbols and
negative symbols.
c) All dates and times appearing with symbols shall use the conventions given in
ISO 8601-1 and ISO 8601-2.
4.3 Other symbols
Other standards specify additional symbols, that are applicable to specific varieties or
types of medical devices or that are applicable to specific situations. References provide
examples of the sources of these additional symbols.
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;
Note 1: For ease of use, Table 1 is grouped by symbol category. As far as usage is concerned,
the categories of symbol groupings have no meaning. The order in which symbols appear
and the categories they are in have no priority. See Appendix A for examples of symbol
usage.
Note 2: Each symbol in the ISO and IEC symbol database
(https://www.iso.org/obp/ui/#home) has a reference number and registration date. This
information is given in the last column of Table 1.
......
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.
......
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
ICS 01.080.20; 11.040.01
C37
People's Republic of China pharmaceutical industry standards
YY/T 0466.1-2009/ISO 15223-1.2007
Partially replaced YY 0466-2003
Medical equipment used with medical device labels,
Signs and symbols provide information
Part 1. General requirements
(ISO 15223-1.2007, IDT)
Posted 2009-11-25
2010-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 2 General requirements
4.1 Proposal 2 uses symbols
4.2 requirements 2
5 Symbol 3
Appendix A (informative) Example 8
Appendix B (normative) proposed using 10 symbols in YY/T 0466.1 in
Basic Mode Appendix C (normative) Symbol Design 11
Appendix D (informative) General prohibition sign 12
References 13
YY/T 0466.1-2009/ISO 15223-1.2007
Foreword
YY/T 0466 "medical devices for medical device labels, labeling and information symbols" is divided into two parts.
--- Part 1. General requirements;
--- Part 2. Symbol development, selection and confirmation.
This section YY/T Section 10466 of.
This part identical with ISO 15223-1.2007 "medical devices for medical device labels, labeling and information symbols 1
Part I. General requirements "(in English).
This section is being drafted and in Part 2 of the common place of the standard YY 0466-2003. Compared with YY 0466-2003, the main technical
Surgery changes are as follows.
--- YY 0466-2003 for the safe and effective use of medical devices, to users and other personnel provisions for providing important letter
Interest symbols. This standard is a revised version of this section to determine the expression system for medical devices safe and effective use of information symbols
Fixed and usage requirements, but also meet the requirements of this section lists the symbols.
--- Part 2 to Part 1 included the development, selection and confirmation process prescribed symbols, its purpose is to ensure that Part 1
Symbol contained readily understood by the target group.
This section of the Appendix A and Appendix D is an informative annex, Annex B and Annex C is normative appendix.
This part is proposed by the State Food and Drug Administration Medical Device Division.
This part of the National Standardization Technical Committee on Medical Device Quality Management and General Requirements (SAC/TC221) centralized.
This section is drafted. Medical Device Quality Management and Standardization Technical Committee general requirements, limited Beijing Hua Yi Xie Certification
the company.
The main drafters of this section. Wu Junhua, Chen Zhigang, Milan English, Qin Shuhua WORKER.
This Part replaces. YY 0466-2003.
YY/T 0466.1-2009/ISO 15223-1.2007
introduction
YY/T 0466 made a number of symbols used to convey information to the regulatory body that the projects these symbols and safety for medical devices
Fair use is very important. Thus, the scope of many regulations require these symbols and instruments appear together. This information may be required in the instrument
On the label as part of, or together with the equipment provided. Many countries require medical instruments represent information in their own language, which gives the instrument
Manufacturers and users increases the problem.
Manufacturers try to reduce costs by simplifying the mark or reasonable changes. When a single label or part of the file contains multiple languages
, It will cause problems translation, design and logistics. Medical Device User for many different languages on the label will be confused, and
Delays in determining the appropriate language. YY/T 0466 by using a clearly defined meaning of the solution internationally recognized symbols, raised these issues
Summary program.
When editing YY/T 0466 in symbols, ISO /T C210 aware of the development needs and proposals symbol system uses a method expression,
This will be the YY/T 0466 Part 2 theme symbol of the development, selection and validation.
This section YY/T is expected in 0466 mainly by various countries of medical devices labeled with different language requirements for selling the same product
Medical device manufacturers. YY/T 0466 in this section can also help.
--- Other medical equipment dealer or manufacturer's representative;
--- Responsible for the training of health care providers and those who were trained;
--- After the listing of staff responsible for the alert;
--- Health regulatory bodies, testing organizations, certification bodies and others responsible for the implementation of medical device regulations and be responsible for post-marketing surveillance
organization.
--- From a variety of sources to obtain medical equipment and medical equipment to master different languages customer or end user.
YY/T 0466.1-2009/ISO 15223-1.2007
Medical equipment used with medical device labels,
Signs and symbols provide information
Part 1. General requirements
1 Scope
YY/T 0466 This section is determined for the expression of safe and effective use of medical devices development and use of request for information symbols, are also listed
A symbol of this section meet YY/T 0466 requirements of.
YY/T 0466 This section applies only in a wide range of medical devices sold worldwide symbol. These symbols can be used in equipment or
The packaging or on the accompanying documents.
2 Normative references
The following documents contain provisions which, through YY/T 0466 reference in this text, constitute provisions of this part. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
GB/T 7408 Data elements and interchange formats - Information interchange dates and times (ISO 8601, IDT)
GB/T 23371.3 Electrical equipment Basic principles for graphical symbols - Part 3. Application guide (IEC 80416-3, IDT)
IEC 80416-1.2001 Basic principles for graphical symbols for equipment - Part 1. Initial symbol of the establishment
ISO 80416-2 Basic principles for graphical symbols for equipment - Part 2. Form and use of arrows
Applicability Guide screen and display of graphical symbols. ISO 80416-4 basic principles for graphical symbols for equipment - Part 4
(icon)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
For a one or a group of objects or more properties of thinking represented.
3.2
Attached symbol prototype represents a standard original law, provides for the use, application and use of symbol prototypes.
[IEC 80416-1.2001, the definition of 3.6]
3.3
Use common things include alphanumeric characters icon or graphical representations.
3.4
On the medical device written, printed or graphic information.
Note 1. When the actual situation is difficult to achieve, this term includes providing single or multiple devices on the packaging information.
Note 2. According GHTF/SG1/N043.2005 rewrite.
YY/T 0466.1-2009/ISO 15223-1.2007
......
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