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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 0466.1-2016English145 Add to Cart 0--10 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 0466.2-2015English145 Add to Cart 0--10 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 Days<=3 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 0466-2003English125 Add to Cart 0--10 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Older Standard (superseded by this standard) YY 0466-2003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.