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YY 0505-2012 PDF English

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YY 0505-2012: Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests
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Status: Obsolete

YY 0505: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0505-2012English185 Add to Cart 0-9 seconds. Auto-delivery Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests Obsolete
YY 0505-2005EnglishRFQ ASK 8 days Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests Obsolete

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YY 0505-2012: Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests


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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) Issued on. DECEMBER 17, 2012 Implemented on. JANUARY 1, 2014 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 Introduction... 5 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.

1 Scope and object

This Standard applies to ELECTROMAGNETIC COMPATIBILITY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereinafter referred to as EQUIPMENT and SYSTEMS, respectively.

2 Terminology and definitions

For the purposes of this Collateral Standard, the terms and definitions given in GB 9706.1-2007, GB 9706.15-2008, YY 0709-2009, YY/T 0316-2008 and the following apply.

3 General requirements

Either the essential performance of the EQUIPMENT or SYSTEM shall be identified (see Annex G for guidance on identifying the essential performance) or the performance of all FUNCTIONS of the EQUIPMENT or SYSTEM shall be considered essential performance for the purpose of IMMUNITY testing [see 36.202.1 j]]. Non-medical electrical equipment that is supplied as part of a SYSTEM is exempt from the EMC testing requirements of this Standard, provided all of the following conditions are met (see also Annex H).

6 Identification, marking and documents

This equipment/system is intended for use by healthcare professionals only. where “[EQUIPMENT or SYSTEM]” shall be replaced with the MODEL or TYPE REFERENCE of the EQUIPMENT or SYSTEM.

36 ELECTROMAGNETIC COMPATIBILITY

MEDICAL ELECTRICAL EQUIPMENT containing only simple electrical components like motors and switches and not utilizing any electronic circuitry that generates or uses frequencies above 9 kHz (e.g. some dental drills, some ventilators, some operating tables) may be classified in accordance with GB 4343.1. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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