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YY/T 0466.2-2015

Chinese Standard: 'YY/T 0466.2-2015'
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YY/T 0466.2-2015English170 Add to Cart 0--15 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 Valid YY/T 0466.2-2015
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Detail Information of 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: 18,153
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Older Standard (superseded by this standard): YY 0466-2003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
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 01.080.20; 11.040.01
C 37
YY/T 0466.2-2015 / ISO 15223-2.2010
Partly replacing YY 0466-2003
Medical devices - Symbols to be used with medical device
labels, labelling, and information to be supplied –
Part 2. Symbol development, selection and validation
医疗器械 用于医疗器械标签, 标记和提供信息的符号
第 2部分. 符号的制订, 选择和确认
(ISO 15223-2.2010, IDT)
ISSUED ON. MARCH 2, 2015
IMPLEMENTED ON. JANUARY 1, 20161
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 4
Introduction ... 6
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 9
4 Principles for identification and development of new symbols ... 11
4.1 Identifying the need for a symbol ... 11
4.2 Symbols with horizontal applications ... 11
4.3 Symbols for use within a restricted range of device types ... 11
5 Process for selecting and validating symbols for inclusion in ISO 15223-1
... 11
6 Classification of risk ... 17
7 Concept development ... 18
7.1 Existence of other symbols ... 18
7.2 Symbol design ... 18
8 Evaluation ... 19
8.1 Testing early symbol concepts ... 19
8.2 Comprehension testing ... 19
8.3 Memory testing ... 20
8.4 Usability testing ... 20
9 Acceptance criteria ... 21
9.1 General ... 21
9.2 Symbols with no to low safety relevance ... 21
9.3 Symbols with moderate to high safety relevance ... 22
Annex A (normative) Information to be provided during the symbol development
process for adoption of a symbol into ISO 15223-1 ... 23
Annex B (normative) ISO/TC 145/SC 3 proposal for graphical symbols ... 24
Annex C (normative) IEC/SC 3C proposal for graphical symbol form ... 27
Bibliography ... 29
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 2 of YY/T 0466.
This Part is drafted according to the rules given in GB/T 1.1-2009.
This Part, together with published Part 1 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”, replaces YY 0466-2003. Compared with YY 0466-
2003, the main technical changes are as follows.
- YY 0466-2003 is divided into two parts after revision. Part 1 defines the
requirements for the development and use of information symbols for the safety
and effective use of medical devices. It also lists the symbols that meet the
requirements of Part 1;
- This Part specifies the process for the development, selection and validation of
candidate symbols proposed for inclusion in Part 1. The aim is to ensure that the
symbols contained in Part 1 are easily understood by the target group.
This Part uses the translation method to equivalently adopt ISO 15223-2.2010
“Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 2. Symbol development, selection and validation”.
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 State Food and......
Related standard:   YY/T 0466.1-2016  YY/T 0468-2015
   
 
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