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 (English)
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, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
1 Scope
This part of YY/T 0466 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.
The purpose of this part is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.
If the symbol validation process detailed in this part has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.
This part is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 (ISO 15223-1:2007, IDT)
ISO 9186-1:2007 Graphical symbols - Test methods - Part 1: Methods for testing comprehensibility
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 80416-2 Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
appropriateness ranking test
procedure for ranking candidate symbols according to their considered appropriateness for representing a particular meaning
3.2
associative strength test
procedure for comparing the strength of an association between a candidate symbol and several possible meanings
3.3
characteristic information
information that represents the property or properties of a symbol
3.4
comprehension test
procedure for quantifying the degree of understanding by the target group of the candidate symbol
Note: Adapted from ISO 9186-1: 2007, definition 3.1.
3.5
description
normative text that defines the purpose, the application and the use of the symbol
Note: Adapted from IEC 80416-1: 2008, definition 3.2.
3.6
symbol concept
diagrammatic representation of a candidate symbol which conveys the essential elements of the symbol but which has not yet been produced as a symbol original on a pattern template
3.7
symbol original
drawing of a graphical symbol, including the corner markings, prepared in accordance with IEC 80416-1 and, where appropriate, ISO 80416-2
Note: Adapted from IEC 80416-1: 2008, definition 3.8.
3.8
symbol used in medical device labelling
graphic representation appearing on the label and/or associated documentation of a medical device which communicates characteristic information without the supplier or receiver of the information relying on knowledge of the language of a particular nation or people
Contents
Foreword I
Introduction II
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for identification and development of new symbols
4.1 Identifying the need for a symbol
4.2 Symbols with horizontal applications
4.3 Symbols for use within a restricted range of device types
5 Process for selecting and validating symbols for inclusion in ISO 15223-1
5.1 General
5.2 Initial evaluation
5.3 Second evaluation
6 Classification of risk
7 Concept development
7.1 Existence of other symbols
7.2 Symbol design
8 Evaluation
8.1 Testing early symbol concepts
8.2 Comprehension testing
8.3 Memory testing
8.4 Usability testing
9 Acceptance criteria
9.1 General
9.2 Symbols with no to low safety relevance
9.3 Symbols with moderate to high safety relevance
Annex A (Normative) Information to be provided during the symbol development process for adoption of a symbol into ISO 15223-1
Annex B (Normative) ISO/TC 145/SC 3 proposal for graphical symbols
Annex C (Normative) IEC/SC 3C proposal for graphical symbol form
Bibliography
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 (English)
Standard No.
YY/T 0466.2-2015
Status
valid
Language
English
File Format
PDF
Word Count
8500 words
Translation Price(USD)
140.0
Implemented on
2016-1-1
Delivery
via email in 1 business day
Detail of YY/T 0466.2-2015
Standard No.
YY/T 0466.2-2015
English Name
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, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
1 Scope
This part of YY/T 0466 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.
The purpose of this part is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.
If the symbol validation process detailed in this part has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.
This part is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 (ISO 15223-1:2007, IDT)
ISO 9186-1:2007 Graphical symbols - Test methods - Part 1: Methods for testing comprehensibility
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 80416-2 Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
appropriateness ranking test
procedure for ranking candidate symbols according to their considered appropriateness for representing a particular meaning
3.2
associative strength test
procedure for comparing the strength of an association between a candidate symbol and several possible meanings
3.3
characteristic information
information that represents the property or properties of a symbol
3.4
comprehension test
procedure for quantifying the degree of understanding by the target group of the candidate symbol
Note: Adapted from ISO 9186-1: 2007, definition 3.1.
3.5
description
normative text that defines the purpose, the application and the use of the symbol
Note: Adapted from IEC 80416-1: 2008, definition 3.2.
3.6
symbol concept
diagrammatic representation of a candidate symbol which conveys the essential elements of the symbol but which has not yet been produced as a symbol original on a pattern template
3.7
symbol original
drawing of a graphical symbol, including the corner markings, prepared in accordance with IEC 80416-1 and, where appropriate, ISO 80416-2
Note: Adapted from IEC 80416-1: 2008, definition 3.8.
3.8
symbol used in medical device labelling
graphic representation appearing on the label and/or associated documentation of a medical device which communicates characteristic information without the supplier or receiver of the information relying on knowledge of the language of a particular nation or people
Contents of YY/T 0466.2-2015
Contents
Foreword I
Introduction II
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for identification and development of new symbols
4.1 Identifying the need for a symbol
4.2 Symbols with horizontal applications
4.3 Symbols for use within a restricted range of device types
5 Process for selecting and validating symbols for inclusion in ISO 15223-1
5.1 General
5.2 Initial evaluation
5.3 Second evaluation
6 Classification of risk
7 Concept development
7.1 Existence of other symbols
7.2 Symbol design
8 Evaluation
8.1 Testing early symbol concepts
8.2 Comprehension testing
8.3 Memory testing
8.4 Usability testing
9 Acceptance criteria
9.1 General
9.2 Symbols with no to low safety relevance
9.3 Symbols with moderate to high safety relevance
Annex A (Normative) Information to be provided during the symbol development process for adoption of a symbol into ISO 15223-1
Annex B (Normative) ISO/TC 145/SC 3 proposal for graphical symbols
Annex C (Normative) IEC/SC 3C proposal for graphical symbol form
Bibliography
