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YY/T 0466.1-2009 (YYT0466.1-2009)

YY/T 0466.1-2009_English: PDF (YYT 0466.1-2009, YYT0466.1-2009)
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YY/T 0466.1-2009English719 Add to Cart 3 days [Need to translate] Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements Obsolete YY/T 0466.1-2009

BASIC DATA
Standard ID YY/T 0466.1-2009 (YY/T0466.1-2009)
Description (Translated English) Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements
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 18,147
Date of Issue 2009-11-25
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY 0466-2003
Quoted Standard GB/T 7408; GB/T 23371.3; IEC 80416-1-2001; ISO 80416-2; ISO 80416-4
Adopted Standard ISO 15223-1-2007, IDT
Drafting Organization Medical Device Quality Management and General Requirements Standardization Technical Committee
Administrative Organization National Standardization Technical Committee of Medical Device Quality Management and General Requirements
Regulation (derived from) Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Proposing organization State Food and Drug Administration Medical Device Division
Issuing agency(ies) China Food and Drug Administration
Summary This standard provides for the expression of safe and effective medical devices making use of information symbols and use requirements are also listed to meet YY/T 0466 requirements of this part of the sign. YY/T 0466 applies only to this part of the global sales of a wide range of medical equipment symbols. These symbols can be used in equipment or packaging or accompanying documents.

Standards related to: YY/T 0466.1-2009

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
ICS 01.080.20; 11.040.01
C37
People's Republic of China pharmaceutical industry standards
YY/T 0466.1-2009/ISO 15223-1.2007
Partially replaced YY 0466-2003
Medical equipment used with medical device labels,
Signs and symbols provide information
Part 1. General requirements
(ISO 15223-1.2007, IDT)
Posted 2009-11-25
2010-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 2 General requirements
4.1 Proposal 2 uses symbols
4.2 requirements 2
5 Symbol 3
Appendix A (informative) Example 8
Appendix B (normative) proposed using 10 symbols in YY/T 0466.1 in
Basic Mode Appendix C (normative) Symbol Design 11
Appendix D (informative) General prohibition sign 12
References 13
YY/T 0466.1-2009/ISO 15223-1.2007
Foreword
YY/T 0466 "medical devices for medical device labels, labeling and information symbols" is divided into two parts.
--- Part 1. General requirements;
--- Part 2. Symbol development, selection and confirmation.
This section YY/T Section 10466 of.
This part identical with ISO 15223-1.2007 "medical devices for medical device labels, labeling and information symbols 1
Part I. General requirements "(in English).
This section is being drafted and in Part 2 of the common place of the standard YY 0466-2003. Compared with YY 0466-2003, the main technical
Surgery changes are as follows.
--- YY 0466-2003 for the safe and effective use of medical devices, to users and other personnel provisions for providing important letter
Interest symbols. This standard is a revised version of this section to determine the expression system for medical devices safe and effective use of information symbols
Fixed and usage requirements, but also meet the requirements of this section lists the symbols.
--- Part 2 to Part 1 included the development, selection and confirmation process prescribed symbols, its purpose is to ensure that Part 1
Symbol contained readily understood by the target group.
This section of the Appendix A and Appendix D is an informative annex, Annex B and Annex C is normative appendix.
This part is proposed by the State Food and Drug Administration Medical Device Division.
This part of the National Standardization Technical Committee on Medical Device Quality Management and General Requirements (SAC/TC221) centralized.
This section is drafted. Medical Device Quality Management and Standardization Technical Committee general requirements, limited Beijing Hua Yi Xie Certification
the company.
The main drafters of this section. Wu Junhua, Chen Zhigang, Milan English, Qin Shuhua WORKER.
This Part replaces. YY 0466-2003.
YY/T 0466.1-2009/ISO 15223-1.2007
introduction
YY/T 0466 made a number of symbols used to convey information to the regulatory body that the projects these symbols and safety for medical devices
Fair use is very important. Thus, the scope of many regulations require these symbols and instruments appear together. This information may be required in the instrument
On the label as part of, or together with the equipment provided. Many countries require medical instruments represent information in their own language, which gives the instrument
Manufacturers and users increases the problem.
Manufacturers try to reduce costs by simplifying the mark or reasonable changes. When a single label or part of the file contains multiple languages
, It will cause problems translation, design and logistics. Medical Device User for many different languages on the label will be confused, and
Delays in determining the appropriate language. YY/T 0466 by using a clearly defined meaning of the solution internationally recognized symbols, raised these issues
Summary program.
When editing YY/T 0466 in symbols, ISO /T C210 aware of the development needs and proposals symbol system uses a method expression,
This will be the YY/T 0466 Part 2 theme symbol of the development, selection and validation.
This section YY/T is expected in 0466 mainly by various countries of medical devices labeled with different language requirements for selling the same product
Medical device manufacturers. YY/T 0466 in this section can also help.
--- Other medical equipment dealer or manufacturer's representative;
--- Responsible for the training of health care providers and those who were trained;
--- After the listing of staff responsible for the alert;
--- Health regulatory bodies, testing organizations, certification bodies and others responsible for the implementation of medical device regulations and be responsible for post-marketing surveillance
organization.
--- From a variety of sources to obtain medical equipment and medical equipment to master different languages customer or end user.
YY/T 0466.1-2009/ISO 15223-1.2007
Medical equipment used with medical device labels,
Signs and symbols provide information
Part 1. General requirements
1 Scope
YY/T 0466 This section is determined for the expression of safe and effective use of medical devices development and use of request for information symbols, are also listed
A symbol of this section meet YY/T 0466 requirements of.
YY/T 0466 This section applies only in a wide range of medical devices sold worldwide symbol. These symbols can be used in equipment or
The packaging or on the accompanying documents.
2 Normative references
The following documents contain provisions which, through YY/T 0466 reference in this text, constitute provisions of this part. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
GB/T 7408 Data elements and interchange formats - Information interchange dates and times (ISO 8601, IDT)
GB/T 23371.3 Electrical equipment Basic principles for graphical symbols - Part 3. Application guide (IEC 80416-3, IDT)
IEC 80416-1.2001 Basic principles for graphical symbols for equipment - Part 1. Initial symbol of the establishment
ISO 80416-2 Basic principles for graphical symbols for equipment - Part 2. Form and use of arrows
Applicability Guide screen and display of graphical symbols. ISO 80416-4 basic principles for graphical symbols for equipment - Part 4
(icon)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
For a one or a group of objects or more properties of thinking represented.
3.2
Attached symbol prototype represents a standard original law, provides for the use, application and use of symbol prototypes.
[IEC 80416-1.2001, the definition of 3.6]
3.3
Use common things include alphanumeric characters icon or graphical representations.
3.4
On the medical device written, printed or graphic information.
Note 1. When the actual situation is difficult to achieve, this term includes providing single or multiple devices on the packaging information.
Note 2. According GHTF/SG1/N043.2005 rewrite.
YY/T 0466.1-2009/ISO 15223-1.2007
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