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YY 0505-2012

Chinese Standard: 'YY 0505-2012'
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YY 0505-2012English395 Add to Cart 0--15 minutes. Auto immediate delivery. Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests Valid 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Older Standard (superseded by this standard): YY 0505-2005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
YY
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
C 30
YY 0505-2012 / IEC 60601-1-2.2004
Replacing YY 0505-2005
Medical electrical equipment - Part 1-2. General
requirements for safety - Collateral standard.
Electromagnetic compatibility -
Requirements and tests
(IEC 60601-1-2.2004, IDT)
医用电气设备 第 1-2部分. 安全通用要求
并列标准. 电磁兼容 要求和试验
ISSUED ON. DECEMBER 17, 2012
IMPLEMENTED ON. JANUARY 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 4 
Introduction ... 6 
SECTION ONE - GENERAL ... 8 
1 Scope and object ... 8 
2 Terminology and definitions ... 8 
3 General requirements ... 14 
6 Identification, marking and documents ... 15 
SECTION TWO - FOUR ... 40 
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION ... 40 
36 ELECTROMAGNETIC COMPATIBILITY ... 40 
SECTION SIX - TEN ... 65 
Annex A (Informative) General guidance and rationale ... 66 
Annex B (Informative) Example completion of Tables 201 through 208 ... 102 
Annex C (Informative) Guidance in classification according to GB 4824 ... 112 
Annex D (Informative) Guidance in the application of YY 0505 ... 116 
to Particular Standards ... 116 
Annex D (Informative) ELECTROMAGNETIC ENVIRONMENTS ... 120 
Annex F (Normative) Normative references ... 121 
Annex G (Informative) Guidance in the identification of essential performance
... 123 
Annex H (Informative) Guidance for determining if non-medical electrical
equipment used in a SYSTEM is exempt from the EMC testing requirements of
this Standard ... 124 
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
The standard for safety of medical electrical equipment mainly consists of the
first part “general requirements for safety” and the second part “specific
requirements for safety”.
This Standard is a collateral standard of GB 9706.1-2007 Medical electrical
equipment - Part 1. General requirements for safety. In addition to this Standard,
other relative collateral standards of GB 9706.1-2007 are as follows.
- GB 9706.15-2008 Medical electrical equipment - Part 1. General
requirements for safety - 1. Collateral standard. Safety requirements for
medical electrical systems (IEC 60601-1-1.2000, IDT);
- GB 9706.12-1997 Medical electrical equipment - Part 1. General
requirements for safety 3.collateral STANDARD. General requirements for
radiation protection in diagnostic X-ray equipment (idt, IEC 60601-1-
3.1994);
- YY/T 0708-2009 Medical electrical equipment - Part 1-4. General
requirements for safety - collateral standard. programmable electrical
medical systems (IEC 60601-1-4.2000, IDT);
- YY 0709-2009 Medical electrical equipment - Part 1-8. General
requirements for safety - Collateral standard. General requirements, tests
and guidance for alarm systems in medical electrical equipment and
medical electrical systems (IEC 60601-1-8.2003, IDT).
This Standard replaces YY 0505-2005 Medical electrical equipment - Part 1-2.
General requirements for safety - Collateral standards. Electromagnetic
compatibility - Requirements and tests.
Compared this Standard with YY 0505-2005, the main differences are as
follows of which this Standard.
- made some editorial modifications so as to be consistent with the base
standard; for example, “radio frequency electromagnetic field radiation”
was modified to “radio frequency electromagnetic field radiation”; “RF”
was modified to “Radio Frequency”;
- added requirements for A type special equipment and system;
- added YY 0709-2009 into references; deleted IEC 60601-1.1988 (see
Annex F);
- added Annex G, Annex H;
- used five bold to express terms and terms of reference in Clause 2.
This Standard identically adopts IEC 60601-1-2.2004 (Edition 2.1), i.e., IEC
60601-1-2.2001+A1.2004 Medical electrical equipment - Part 1-2. General
requirements for safety - Collateral standard. Electromagnetic compatibility -
Requirements and tests. Compared with IEC 60601-1-2.2004 (Edition 2.1), this
Standard makes the following editorial modifications.
- modified some layout formats in accordance with GB/T 1.1;
- for other international standards which are used as references in standard,
if they have been converted into China national standards, this Standard
shall replace the international standard number with the corresponding
one of the national standard number of which the relation of use shall be
indicated in Annex F;
- for editorial convenience, adjusted the appendix code from three letters
to one letter; for example, Annex AAA was adjusted to Annex A.
Please note that some of the contents of this document may be related to
patents. The issuer of this document is not responsible for identifying such
patents.
This Standard was proposed by and shall be under the jurisdiction of National
Technical Committee on Medical Electrical Equipment of Standardization
Administration of China (SAC/TC 10).
The drafting organizations of this Standard. Shanghai Institute of Medical
Instrumentation, Liaoning Cape Medical System Co., Ltd., Shanghai Siemens
Medical Devices Co., Ltd..
Main drafters of this Standard. Liu Jinglin, Gao Zhong, Niu Shuai, Tian Yanfang,
Wang Weiming, Jiang Sui, Zhou Lidong.
Version of standard substituted by this Standard is.
- YY 0505-2005.
Medical electrical equipment - Part 1-2. General
requirements for safety - Collateral standard.
Electromagnetic compatibility -
Requirements and tests
SECTION ONE - GENERAL
1 Scope and object
1.201* Scope
This Standard applies to ELECTROMAGNETIC COMPATIBILITY of MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS,
hereinafter referred to as EQUIPMENT and SYSTEMS, respectively.
1.202 Object
This Standard specifies requirem......
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