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YY/T 0466.2-2015 (YYT 0466.2-2015)

Chinese standards (related to): 'YY/T 0466.2-2015'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY/T 0466.1-2016English150 Add to Cart 0--3 minutes. Auto immediate delivery. Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements YY/T 0466.1-2016 Valid YYT 0466.1-2016
YY/T 0466.2-2015English150 Add to Cart 0--3 minutes. Auto immediate delivery. 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 Valid YYT 0466.2-2015
YY/T 0466.1-2009English699 Add to Cart 3 days Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements YY/T 0466.1-2009 Obsolete YYT 0466.1-2009
YY 0466-2003English140 Add to Cart 0--3 minutes. Auto immediate delivery. Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied YY 0466-2003 Obsolete YY 0466-2003


   
BASIC DATA
Standard ID YY/T 0466.2-2015 (YY/T0466.2-2015)
Description (Translated English) Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation
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 18,193
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Older Standard (superseded by this standard) YY 0466-2003
Quoted Standard YY/T 0466.1-2009; ISO 9186-1-2007; IEC 80416-1-2008; ISO 80416-2
Adopted Standard ISO 15223-2-2010, IDT
Drafting Organization Beijing Hua Yi Xie Certification Co., Ltd.
Administrative Organization National Medical Device Quality Management and General Requirements Standardization Technical Committee
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard specifies the inclusion in ISO 15223-1 symbol of the development, selection and validation process. The purpose of this section is to ensure the inclusion of ISO 15223-1 symbols easy to understand the target group. If you already meet the symbol validation process detailed in this section, then, such as ISO 14971 and IEC 62366 residual risks set forth in the medical device is considered the symbol of the availability of relevant acceptable, unless there is objective evidence that unacceptable. This section is designed to meet the regulatory requirements is not limited to sign or symbol on regulatory guidelines set forth in the mark.


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-......