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

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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.

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 and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C37
Classification of International Standard	01.080.20; 11.040.01
Word Count Estimation	19,126
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Older Standard (superseded by this standard)	YY 0466-2003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
Regulation (derived from)	The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)	State 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.