YY/T 0466.2-2015 PDF in English
YY/T 0466.2-2015 (YY/T0466.2-2015, YYT 0466.2-2015, YYT0466.2-2015)
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Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
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Standards related to (historical): YY/T 0466.2-2015
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YY/T 0466.2-2015: PDF in English (YYT 0466.2-2015) 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) of Appendix A.
If the symbol is an existing symbol or based on an existing symbolic system, the relevant parts required in Appendix A may be referenced by reference to the published document
provide.
Note. The initial evaluation does not have to consider the information in Appendix A, h) and i). However, if you have completed any testing or registration, at this time ISO /TC210/WG3
The information should be available.
ISO /TC210/WG3 will initially evaluate and provide an assessment of the symbolic proposal, whether it is recommended to further develop the symbolic comments, such as
It is recommended that ISO /TC145/SC3 or IEC /SC3C be used to seek the registration of symbols.
If the result of the initial evaluation is further developed, the proposer shall be informed and may proceed in accordance with 5.3.
If the result of the initial evaluation is not further developed, the proposer shall be informed and obtained the interpretation of the decision.
5.3 secondary evaluation
If the initial evaluation is recommended for further development of the symbol, the candidate symbol needs to be submitted to the international symbol registration body, which requires Chapter 8 and
Chapter 9 of the relevant safety test. In order for the candidate symbol to be included in ISO 15223-1, the proposer has the first ISO /TC210/WG3
Submit the candidate symbol to the international registrar's choice, and then carry out the relevant safety test (option 1 below), or vice versa,
Related safety tests, and then submit the candidate symbols to the international registrar (option 2) via ISO /TC210/WG3.
ISO /TC210 The Secretariat will keep the proponent informed of the proposed progress.
Option 1).
1) The proposer shall prepare documents submitted by ISO /TC145/SC3 or IEC /SC3C, such as ISO /TC210/WG3
Recommend, where appropriate) 1), in accordance with Appendix B or Appendix C, submit the registration documents and information required in a) to g) of Appendix A to
ISO /TC210 Secretariat. If the candidate symbol has been registered, the proposer shall prepare and submit the requirements of a) to h) of Appendix A
To the ISO /TC210 Secretariat.
1) The requirements for the submission of ISO /TC145/SC3 and IEC /SC3C are different and require two appendices, each corresponding to an appendix.
Note. This option does not require the proposer to carry out the tests described in Chapters 8 and 9 before submitting the registration documents to the ISO /TC210 Secretariat.
2) ISO /TC210 Secretariat will submit candidate symbols to ISO /TC145/SC3 or, if not registered,
IEC /SC3C for registration.
3) If the candidate symbol is approved after ISO /TC145/SC3 or IEC /SC3C assessment, the proposer shall complete the
8 and 9, and submit the information required in i) of Appendix A via the ISO /TC210 Secretariat
To ISO /TC210/WG3.
4) If, after ISO /TC145/SC3 or IEC /SC3C assessment (even after consideration of the redesigned proposal),
If the symbol is considered not suitable for registration, ISO /TC210/WG3 should ask the proposer whether to proceed with the symbol making process. in case
The proposer decides to proceed and shall carry out the tests described in Chapters 8 and 9 and submit it by the ISO /TC210 Secretariat
Test results and the information required in Appendix A of Appendix A to ISO /TC210/WG3.
5) ISO /TC210/WG3 will conduct a second evaluation, taking into account the additional information from the tests and the information provided in Chapters 8 and 9
Whether the candidate symbol satisfies the acceptable criteria based on the safety dependency.
6) If the candidate symbol does not meet the acceptable criteria based on safety dependencies, ISO /TC210/WG3 will inform the proposer and give
Explain the resolution. The proposer may redesign the symbol and resubmit the proposal via the ISO /TC210 Secretariat.
7) If the candidate symbol is considered suitable for inclusion in ISO 15223-1, the formal voting procedure for ISO /TC210 will be submitted,
ISO 15223-1.
8) If accepted by ISO /TC210 formal voting procedure and registered by ISO /TC145/SC3 or IEC /SC3C,
The symbols are published in ISO 15223-1.
9) If accepted by the formal voting procedure of ISO /TC210, but not by ISO /TC145/SC3 or IEC /SC3C Note
, ISO /TC145/SC3 or IEC /SC3C and ISO /TC210/WG3 were not resolved,
ISO /TC210 The Secretariat shall request that the ISO Technical Management Committee be granted without registration.
Option 2).
1) If recommended by ISO /TC210/WG3 in accordance with Appendix B or Appendix C, the proponent shall prepare the ISO /TC145/SC3
Or the documents required by the IEC /SC3C submission. The proposer should also complete the tests described in Chapters 8 and 9
Submit the test results, the registration documents and the information given in a) to g) and i) of Appendix A to the Secretariat. If the candidate symbol has been
Upon registration, the proposer shall prepare and submit the information required in a) to i) of Appendix A to the ISO /TC210 Secretariat.
2) ISO /TC210/WG3 will conduct a second evaluation and take into account the additional information derived from the tests and the information provided in Chapters 8 and 9,
Determines whether the candidate symbol satisfies the acceptable criteria based on the safety dependency.
3) If the candidate symbol does not meet the acceptable criteria based on safety dependencies, ISO /TC210/WG3 will inform the proposer and give
Explain the resolution. The proposer may redesign the symbol and resubmit the proposal via the ISO /TC210 Secretariat.
4) If the candidate symbol is considered appropriate for inclusion in ISO 15223-1 and not yet registered, the ISO /TC210 Secretariat will
The candidate symbols are assigned to ISO /TC145/SC3 or IEC /SC3C for registration.
5) If assessed by ISO /TC145/SC3 or IEC /SC3C, candidate symbols are approved for registration and will be approved by ISO /TC210
The formal voting procedure was submitted in ISO 15223-1.
6) If accepted by the formal voting procedure of ISO /TC210 and registered by ISO /TC145/SC3 or IEC /SC3C,
The adopted symbols are published in ISO 15223-1.
7) If, after ISO /TC145/SC3 or IEC /SC3C assessment (even after consideration of the redesigned proposal) candidates
No. ISO /TC145/SC3 or IEC /SC3C and ISO /TC210/WG3 are not approved.
After the candidate symbol has been accepted by the formal voting procedure of ISO /TC210, the ISO /TC210 secretary
Shall be requested by the ISO Technical Management Committee to be released without registration.
Figure 1 Overview of the symbolic process
6 risk level
Risk analysis should be carried out to evaluate the use of symbols instead of textual representations.
The risk analysis should pay particular attention to the following.
a) if the misinterpretation of the intended meaning of the symbol, the severity of the damage that may occur;
b) the text on the medical device label and its associated risk in multiple languages;
c) the user's language may not appear on the label.
As part of the risk analysis, information relating to candidate symbols should be classified as one of the following.
d) from safety-related to low-security-related
Example 1. Classification number (YY/T 0466.1-2009, symbol 5.15); fragile, carefully placed (YY/T 0466.1-2009, symbol 5.5).
e) from which security is related to high security
Example 2. No secondary sterilization (YY/T 0466.1-2009, symbol 5.25); use period (YY/T 0466.1-2009, symbol 5.12).
Note 1. When considering the possible consequences of misunderstanding, the proposer of the new symbol needs to focus on the typical use of candidate symbols. YY/T 0466.1-2009 4.2 requirements
The manufacturer determines that the use of the symbols in YY/T 0466.1-2009 does not cause additional risk in certain circumstances, or the use of appropriate countermeasures
Control risk.
Note 2. Additional information on risk analysis is available in ISO 14971 [4].
The results of the risk analysis should be recorded in the proposal for the adoption of the symbol for ISO 15223-1 [see Appendix A, A)].
Note 3. If any of the users in this section consider it appropriate, additional testing may be required to support the risk level from the medium to the high security level. Headquarters
The results of any secondary tests are not required to be communicated to ISO /TC210/WG3 via the ISO /TC210 Secretariat.
7 concept development
7.1 The presence of other symbols
In the symbolicization process, the existing symbolic resources should be reviewed to determine whether the symbol of the identified requirements is already present. The review
Should include at least ISO 15223-1, ISO 7000 [1], ISO 7010 [2], IEC 60417-DB [6], IEC /T R60878 [7] and EN980 [9].
Note 1. Existing basic design elements can be used as a basis for new symbols.
Standards developed by professional technical commissions with technical areas related to the proposed new symbols should also be reviewed.
Note 2. The IEC /ISO database can help identify existing symbols with overlapping meanings and should consult the database early in the development process.
7.2 symbol design
This phase includes the collection of design elements in the generation and use of test designs.
The symbol for the initial assessment of appropriateness requires only conceptual graphics. However, once the test design has been selected for further testing
It is advisable to follow a more formal design of the method in IEC 80416-1. Guidance design The basic pattern of symbolic mapping is given in B.2.
It is useful to have a consensus on the title and description before designing the drawings. ISO /T R7239 [3] gives the design problem
Useful guide. The application of the arrow in the symbol applies to ISO 80416-2.
In addition, when this symbol is applied, IEC 80416-3 [8] provides guidelines for the application of symbols in order to maintain visual clarity and overall consistency.
This includes important concepts such as the appropriate method of using the generic prohibition symbol (see Appendix D of YY/T 0466.1-2009).
It is advisable to avoid ambiguity or confusion in order to avoid changes in the direction of the design of the symbol. If the meaning of the symbol depends on the direction, such as the arrow
Point to a specific direction, which should be stated in the description.
Such as when reading with a small print size or when located near other possible symbols, should also consider the legibility of the symbol.
8 evaluation
8.1 Early symbolic test
When a new symbol is developed without a previous model, it is advisable to make the multiple concept gradually reduced to the preferred candidate symbol by evaluation.
At the initial stage, there may be more symbolic versions than the reasonable tests used to understand. The most appropriate waiting for further testing
The selection symbol can be selected using an understanding judgment test. The question of what is expected to be answered. "Which of these symbols best is
Expressed a given meaning?
The simple form of the comprehension judgment test is the "fit degree test". In this trial, the sample target group is based on what they perceive
Conditional meaning Candidate symbol.
In this method, we give the sample target group a meaning and ask them to associate the meaning with the candidate symbol. The candidate symbol is presented to the sample
The target group so as to be arranged in accordance with the degree of appropriateness of its particular meaning. If the candidate symbol is too small, a set of similar symbols will be inserted
Will provide more choices.
Choose the best of the first two or three symbols for a given meaning for further evaluation. Rarely selected candidate symbols are no longer in progress
Step by step.
Chapter 7 of ISO 9186-1..2007 describes the methods that can be used to test candidate symbols (depending on which material is printed on a printed material or computer screen)
One of the most practical) understandability of the more detailed method.
Note. In ISO 9186-1, the "comprehension test" is described as "judgment test", that is, the procedure for judging the comprehensibility of candidate symbols.
8.2 Understanding the test
Understanding the test is to quantify the target group to understand the degree of candidate symbols. Understand the questions that the test is expected to answer. "What do you think is this?
Think "or" what action do you take to respond to this symbol? "
The simple form of understanding the experiment is the "correlation strength test". Candidate symbols may explain more than one. The association strength test can be used for display
Whether there is an approp......
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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