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YY 0466-2003 English PDF

YY 0466-2003 English PDF

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YY 0466-2003: Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied

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Scope

This Standard identifies symbols conventionally used to convey information
essential for proper use to the user and others for safe and effective use of
medical devices. This Standard is primarily intended to be used by.
- manufacturers of medical devices who market their products in a
number of countries having different language requirements for
medical device labelling;
- users of medical devices who draw their supplies from a number of
sources and may have varied language capabilities;
- those responsible for post-market surveillance;
- health care regulatory authorities, testing organizations, certification
bodies and other organizations responsible for implementing
regulations affecting medical devices and having responsibility for
post-market surveillance.
This Standard may also be of assistance to.
- manufacturers having to cope with space limitations on small labels;
- distributors of medical devices or other representatives of
manufacturers;
- health care authorities responsible for training as well as those being
trained.
NOTE. This Standard deals with a small number of symbols that may be used when
appropriate on the device itself, its package or in the accompanying documentation. Many
other standards, such as IEC 60601-1, specify additional symbols that are applicable to
particular kinds or groups of devices, or to particular situations.

Basic Data

Standard ID YY 0466-2003 (YY0466-2003)
Description (Translated English) Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C30
Classification of International Standard 11.040.01
Word Count Estimation 12,11
Date of Issue 6/20/2003
Date of Implementation 1/1/2004
Adopted Standard ISO 15223-2000, IDT
Regulation (derived from) Industry Standard Filing Notice 2010 No. 2
Issuing agency(ies) State Food and Drug Administration


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