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

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.

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

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.

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).