YY / IEC :2004

Transcription

1 Translated English of Chinese Standard: YY YY NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA ICS C 30 YY / IEC :2004 Replacing YY Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC :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 Page 1 of 125

2 Table of Contents Foreword... 4 Introduction... 6 SECTION ONE - GENERAL Scope and object Terminology and definitions General requirements Identification, marking and documents SECTION TWO - FOUR SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION ELECTROMAGNETIC COMPATIBILITY SECTION SIX - TEN Annex A (Informative) General guidance and rationale Annex B (Informative) Example completion of Tables 201 through Annex C (Informative) Guidance in classification according to GB Annex D (Informative) Guidance in the application of YY to Particular Standards Annex D (Informative) ELECTROMAGNETIC ENVIRONMENTS Annex F (Normative) Normative references Annex G (Informative) Guidance in the identification of essential performance Page 2 of 125

3 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 Page 3 of 125

4 Foreword This Standard was drafted in accordance with the rules given in GB/T 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 Medical electrical equipment - Part 1: General requirements for safety. In addition to this Standard, other relative collateral standards of GB are as follows: - GB Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (IEC :2000, IDT); - GB Medical electrical equipment - Part 1: General requirements for safety 3.collateral STANDARD: General requirements for radiation protection in diagnostic X-ray equipment (idt, IEC :1994); - YY/T Medical electrical equipment - Part 1-4: General requirements for safety - collateral standard: programmable electrical medical systems (IEC :2000, IDT); - YY 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 :2003, IDT). This Standard replaces YY Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests. Compared this Standard with YY , 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 into references; deleted IEC :1988 (see Annex F); Page 4 of 125

5 - added Annex G, Annex H; - used five bold to express terms and terms of reference in Clause 2. This Standard identically adopts IEC :2004 (Edition 2.1), i.e., IEC :2001+A1:2004 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. Compared with IEC :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 Page 5 of 125

6 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 Object This Standard specifies requirements and tests for ELECTROMAGNETIC COMPATIBILITY of EQUIPMENT and SYSTEMS and serves as the basis of ELECTROMAGNETIC COMPATIBILITY requirements and tests in Particular Standards 2 Terminology and definitions For the purposes of this Collateral Standard, the terms and definitions given in GB , GB , YY , YY/T and the following apply: (IMMUNITY) COMPLIANCE LEVEL level less than or equal to the IMMUNITY LEVEL for which the EQUIPMENT or SYSTEM meets the requirements of the applicable subclause of NOTE Additional requirements for COMPLIANCE LEVELS are specified in Page 8 of 125