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YY 0505-2012

Search Result of Chinese Standard: 'YY 0505-2012'
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Detail Information of YY 0505-2012; YY0505-2012
Description (Translated English): Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C30
Classification of International Standard: 11.140
Word Count Estimation: 77,717
Date of Issue: 12/17/2012
Date of Implementation: 1/1/2014
Older Standard (superseded by this standard): YY 0505-2005
Adopted Standard: IEC 60601-1-2-2004, IDT
Drafting Organization: Shanghai Medical Device detection
Administrative Organization: National Standardization Technical Committee of Medical Appliances
Regulation (derived from): State Food and Drug Administration Notice 2012 No. 74
Proposing organization: National Medical Electrical Equipment Standardization Technical Committee (SAC/TC 10)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to medical electrical equipment and medical electrical systems (hereinafter referred to equipment and systems) electromagnetic compatibility.

YY 0505-2012
Medical electrical equipment.Part 1-2: General requirements for safety.Collateral standard: Electromagnetic compatibility.Requirements and tests
ICS 11.140
People's Republic of China pharmaceutical industry standards
YY 0505-2012/IEC 60601-1-2:2004
Replacing YY 0505-2005
(IEC 60601-1-2:2004, IDT)
Issued on: 2014-01-01 2012-12-17 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
The first chapter outlines
1 Scope and purpose 1
2 Terms and definitions 1
3 4 General requirements
6 Identification, marking and documents 5
The second to fourth in
The fifth chapter of unwanted or excessive radiation hazard protection
36 20 Electromagnetic Compatibility
Part VI to the tenth chapter
Appendix A (informative) total preparation instructions and guidelines 34
Annex B (informative) Table 201 to Table 208 Example 55
Appendix C (Informative Appendix) GB 4824 Classification Guide 64
Appendix D (Informative Appendix) YY 0505 applied to specific standard guidelines 66
Annex E (informative) Electromagnetic Environment 67
Annex F (normative) Normative documents 68
Annex G (informative) Basic performance determination guide 70
Non-medical electrical equipment Annex H (informative) within the system from EMC testing requirements of this standard determination guide 71
FIG completion table 201 201 --- description of equipment and systems 12 GB 4824
FIG completion table 202 201 --- description of GB 4343 and GB 17743 13 equipment and systems
Figure 203 14 202 The table below shows complete
FIG completion table 203 and 204 205 --- table shows the life support equipment and systems 18
FIG completion table 204 and 205 206 --- table describes non-life-support equipment and systems 18
Figure A.1 radiated immunity test cable arrangement example of FIG. 53
Figure A.2 have a cable and two cable devices maximum size of the example of Figure 54
Figure H.1 non-medical electrical equipment within the system whether from the present standard EMC test requirements determination process 71
YY 0505-2012/IEC 60601-1-2:2004
Table 201 Guidance and manufacturer's declaration electromagnetic emission --- --- 11 for all equipment and systems
Table 202 Guidance and manufacturer's declaration electromagnetic immunity --- --- 14 for all equipment and systems
Table 203 Guidance and manufacturer's declaration electromagnetic immunity --- --- life support equipment and systems 15
Table 204 Guidance and man
Related standard:   YY/T 0287-2017  YY/T 0618-2017
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