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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
YY/T 0466.2-2015
Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 2. Symbol development, selection and validation
ICS 01.080.20; 11.040.01
C37
People's Republic of China Pharmaceutical Industry Standard
Part of the replacement YY 0466-2003
Medical devices are used for medical device labels, tags and
Provide the symbol of the information
Part 2. Development, selection and confirmation of symbols
(ISO 15223-2..2010, IDT)
2015-03-02 Release.2016-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 range 1
2 normative reference document 1
3 Terms and definitions 1
4 Identification and formulation of new symbols 2
4.1 Identification of symbol requirements 2
4.2 Symbols for horizontal application 2
4.3 Symbols used within the scope of the defined instrument type 3
5 to be included in the ISO 15223-1 symbol selection and confirmation process 3
5.1 General 3
5.2 Initial evaluation 3
5.3 secondary evaluation 3
6 Risk Level 6
7 concept development 6
7.1 The presence of other symbols 6
7.2 Symbol design 6
8 evaluation 7
8.1 Early symbolic concept test 7
8.2 Understanding the test 7
8.3 Memory test 7
8.4 Usability test 7
Acceptable Criteria 8
9.1 General 8
9.2 security is not related to the safety of low-related symbols 8
9.3 Security Moderate correlation to safety Highly relevant symbols 8
Appendix A (Normative Appendix) Information to be used in the formulation of symbols for the adoption of symbols for ISO 15223-1 9
Appendix B (normative) ISO /TC145/SC3 Graphical Symbols Proposal 10
Appendix C (Normative Appendix) IEC /SC3C Proposal for graphic symbol graphics 12
Reference 14
Preface
YY/T 0466 "Symbols for Medical Device Labeling, Marking and Information for Medical Devices" are divided into the following two parts.
- Part 1. General requirements;
Part 2. Development, selection and confirmation of symbols.
This part is part 2 of YY/T 0466.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part and the published Part 1 YY/T 0466.1-2009 "Medical Devices for Medical Device Labeling, Marking and Providing Letter
Symbol of the symbol Part 1. General requirements "common to replace the standard YY 0466-2003. Compared with YY 0466-2003, the main technology changes
As follows.
--- YY 0466-2003 standard revised into two parts, Part 1 identified for the expression of medical equipment safety and effective use
The formulation and use of information symbols, and the symbols that meet the requirements of Part 1;
This section specifies the process for the formulation, selection and validation of candidate symbols proposed for inclusion in Part 1. Its purpose is to ensure that the first one
The symbols contained in the section are easy to understand for the target group.
This part uses the translation method equivalent to ISO 15223-2..2010 "Medical devices for medical device labeling, marking and providing information
Symbols Part 2. Symbol making, selection and confirmation ".
Please note that some of the contents of this document may relate to patents and that the issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221) centralized.
This part of the drafting unit. Beijing Guoya Huaguang Certification Co., Ltd.
This part of the main drafters. Milan Ying, Xu Qiang, Zheng Yi Han, Chen Zhigang.
YY/T 0466 part of this part of the replacement YY 0466-2003.
introduction
The symbols proposed by ISO 15223 can be used to convey information that is essential for safe and proper use of medical devices and, in most regulations
The field requires the symbol to appear with the instrument. This information may be required to be marked on the instrument as part of the label, or provided with the instrument.
Many countries require the use of their own language to indicate the textual information of medical devices. This asked the manufacturers and users of the equipment
question. In the face of the requirement to produce labels in many different languages, the manufacturer may have to increase the size of the package or label,
Plus packaging to waste or compress information, thus affecting readability. The user may be confused with the instruments marked in many different languages
Use the appropriate language to find the required information when the delay time. ISO 15223-1 through the use of expressly defined meaning of the language-independent international public
Recognize the symbol to give a solution to the above problem.
When editing symbols into ISO 15223-1..2007, people are aware of the need to develop and express symbols that require a systematic approach. ISO /TC210 first
Systematically elaborated a "good practice" document, "Guidelines for the development and registration of symbols for medical device labeling".
When the guide is issued in the relevant parties, many regulators believe that if the standard "
And thus have more confidence in using symbols instead of text, and some of the best practices for the formulation and use of symbols have been translated into
ISO 15223 normative requirements.
Many medical devices need to be labeled as part of the label, or together with the instrument, constitute a comprehensive approach to risk management
In the security information. For all risk control measures, the manufacturer needs to verify its validity before accepting the safety information. Make
When using standardized symbols agreed upon in international agreements, it can solve the confusion that is brought to the user when it is marked in many different languages.
However, the increase in uncontrolled and uncoordinated symbols is not necessary and will reduce the use of symbols to convey the validity of the security information. this
In addition, some users and regulators have noted that the unrestricted use of unconfirmed symbols is a hazard.
This section contains a confirmation method that proposes inclusion of candidate symbols for ISO 15223-1. In the case where the appropriate symbols are not standardized,
The method can be used by manufacturers and regulators to confirm the use of symbols with medical devices.
To ensure the quality of the symbols recognized by ISO 15223-1, this section establishes a clear process of requirements to influence the
The quality of the symbol, the process elaborates the following requirements.
--- establish demand;
- provide guidance on the development of symbols;
- to test to ensure that candidate symbols are suitable for adoption and use.
The implementation of the detailed process developed in this section will reduce the probability that the ISO 15223-1 approved symbol will be misunderstood.
Note. The contents of this section are intended to be included in the formulation, selection and validation process of symbols in ISO 15223-1. Proposed to be included in the symbol YY/T 0466.1
Signed by the SAC/TC221 Secretariat to the International Organization for Standardization/Medical Device Quality Management and General Requirements Technical Committees/Medical Devices
And named working group (ISO /TC210/WG3), any individual or group can propose symbols.
Medical devices are used for medical device labels, tags and
Provide the symbol of the information
Part 2. Development, selection and confirmation of symbols
1 Scope
This part of YY/T 0466 specifies the process of making, selecting and confirming the symbols contained in ISO 15223-1.
The purpose of this part is to ensure that the symbols included in ISO 15223-1 are readily understood by the target group.
If the detailed symbolic confirmation process of this part has been met, then the availability of the medical instrument symbol, such as ISO 14971
And the residual risk specified in IEC 62366 are considered acceptable unless there is objective evidence that is unacceptable.
This section is not limited to symbols intended to meet regulatory requirements or as defined in the regulatory guidelines for labeling.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009
(ISO 15223-1..2007, IDT)
ISO 9186-1..2007 Graphical symbols - Test methods - Part 1. Comprehensibility test methods (Graphicalsymbols-
Testmethods-Part 1. Methodsfortestingcomprehensibility
IEC 78416-1..2008 Graphical symbols for equipment - Fundamental principles - Part 1. Generating graphical symbols for registration (Basic
principlesforgraphicalsymbolsforuseonequipment-Part 1. Creationofgraphicalsymbolsforregis-
tration
ISO 80416-2 device with graphical symbol representation rules - Part 2. Arrow form and use (Basicprinciplesfor
graphicalsymbolsforuseonequipment-Part 2. Formanduseofarrows)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Appropriate degree arrangement test appropriatenessrankingtest
According to the procedure for sorting the suitability of the candidate symbols to express specific meanings.
3.2
Association strength test associativestrengthtest
Compare the candidate symbols with several possible meanings between the associated strength of the program.
3.3
Characteristic information characteristicinformation
A message that represents one or more characteristics of a symbol.
3.4
Understand the trial comprehensiontest
A quantification procedure for the degree of understanding of candidate symbols for target groups.
Note. Adapted from ISO 9186-1..2007, definition 3.1.
3.5
Description description
Define the purpose of the symbol, apply and use the normative text.
Note. Adapted from IEC 80416-1..2008, defined 3.2.
3.6
Symbolic concept symbolconcept
An icon showing the candidate symbols of the basic elements of the symbol, but it has not been made as a prototype symbol on the pattern template.
3.7
The original symbol symboloriginal
The drawing of graphic symbols includes angle notes, in accordance with IEC 80416-1, and in accordance with ISO 80416-2.
Note. Adapted from IEC 80416-1..2008, defined 3.8.
3.8
Symbols used for medical device marking symbolusedinmedicaldevicelabeling
Appearing on a graphical representation of a medical device label and/or related document, the provider or recipient of the characteristic information it expresses does not
Depends on the language of the country or the population.
Note. Symbols can be abstract drawings or graphical representations, or use familiar objects that include alphanumeric character sets.
3.9
Title title
A unique name for identifying and referring to graphical symbols.
Note. Adapted from IEC 80416-1..2008, definition 3.9.
3.10
Target group targetgroup
Such as age, gender, education, occupation, cultural background, experience and training, and physical and other factors related to the characteristics of the user base.
3.11
Usability usability
Has the characteristics of validity, efficiency, user's easy to learn and user satisfaction.
Note. Adapted from IEC 62366 [10].
4 new symbol recognition and formulation principles
4.1 Identification of symbol requirements
When identifying symbol requirements, consider the following elements.
a) the benefits of using symbols;
b) Expected target group.
- have the training, knowledge and experience associated with medical devices intended for use with candidate symbols;
--- with general medical knowledge.
4.2 Symbols for horizontal applications
In some areas or areas of law, when there is a clear and meaningful need for symbols, it is desirable to develop a horizontal application to a wider range of
Signs of medical devices. These symbols should be used when these symbols are used to meet regulatory requirements. This symbol should be considered as the primary candidate symbol column
Into ISO 15223-1.
4.3 Symbols used within the scope of the defined instrument type
Within the limits of the type of equipment or in a specific area or area of law, as long as the demand is clear and meaningful,
With the symbol. The process of identifying requirements should take into account the target group and the preparation for the release of the new symbol. These symbols may be included in a particular category
The main candidate symbol in the medical device standard. However, they are not included in the main candidate symbols of ISO 15223-1. When there are enough countries
The organization is interested in this type of specific symbol, which may be included in ISO 15223-1, as per ISO /TC210, and
Shall indicate any geographical or other restrictions on its use.
5 to be included in the ISO 15223-1 symbol selection and validation process
5.1 General
The symbols submitted to ISO /TC210 for inclusion in ISO 15223-1 shall be made using the procedures described in this chapter to develop,
confirm.
The proposal to include the symbols of ISO 15223-1 shall be submitted to ISO /TC210 Secretariat. symbolsinfo@aami.org
ISO /TC210/WG3. Any individual or group can propose symbols.
Note 1. The symbolic formulation, selection and validation process is illustrated in Figure 1 in this section.
Note 2. In the formulation of symbols, it is necessary to submit candidate symbols to ISO /TC145/SC3 for approval in ISO 7000 [1], or to
IEC /SC3C for approval in IEC 60417-DB [6].
Note 3. If a new symbol or part of the developed concept is considered, it can be used with the same information as the one contained in Appendix A
Submitted to ISO /TC210/WG3 (prior to the initial evaluation described in 5.2).
5.2 Initial evaluation
The symbol shall be submitted to ISO /TC210/WG3 for initial evaluation, together with the information required in a) to g...