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YY 9706.102-2021 PDF English

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YY 9706.102-2021: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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YY 9706.102-20211280 Add to Cart Auto, 9 seconds. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Valid

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YY 9706.102-2021: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests



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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.140 C 30 Replacing YY 0505-2012 Issued on. MARCH 09, 2021 Implemented on. MAY 01, 2023 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 Introduction... 6 1 Scope, Object and Related Standards... 9 2 Normative References... 10 3 Terms and Definitions... 11 4 General Requirements... 16 5 Identification, Marking and Documents... 17 6 Electromagnetic Compatibility... 41 Annex A (Informative) General Guidance and Rationale... 66 Annex B (Informative) Guide to Marking and Labelling Requirements for ME EQUIPMENT and ME SYSTEMS... 102 Annex C (Informative) Example completion of Table 1 through Table 8... 104 Annex D (Informative) Guidance in classification according to GB 4824... 114 Annex E (Informative) Guidance in the application of particular standards.. 118 Annex F (Informative) ELECTROMAGNETIC ENVIRONMENTS... 122 Annex G (Informative) Guidance for determining if electrical equipment that is not ME EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this Part... 123 Annex H (Informative) Mapping between the elements of YY 0505-2012 and this Part... 125

Foreword

All the technical contents in this Part are mandatory. Medical Electrical Equipment can be divided into the following two parts. --- Part 1.General and Collateral Requirements; --- Part 2.Particular Requirements. This Part is Part 1-2. This Part was drafted as per the rules specified in GB/T 1.1-2009. This Part replaced YY 0505-2012 Medical Electrical Equipment - Part 1-2.General Requirements for Safety - Collateral Standards. Electromagnetic Compatibility - Requirements and Tests. Compared with YY 0505-2012, the major technical differences of this Part are as follows. --- Medical electrical equipment and medical electrical system are referred to as ME equipment and ME system; --- Add some terms and definitions (see Clause 3 of this Edition); --- Delete GB 9706.15-2008 (see Clause 2 of the 2012 Edition); --- Update the year number or standard number of some standards (see Clause 2 of this Edition); --- Add annexes on marking and labelling guidelines and etc. (see Annex B). This Part uses re-drafting method to modify and adopt IEC 60601-1-2.2007 Medical Electrical Equipment – Part 1-2.General Requirements for Basic Safety and Essential Performance – Collateral Standard. Electromagnetic Compatibility – Requirements and Tests. The technical differences and the causes between this Part and IEC 60601-1-2.2007 are as follows. --- Regarding normative references, this Part has made adjustments with technical differences to adapt to China’s technical conditions. The adjustments are reflected in Clause 2 Normative References. The specific adjustments are as follows.  Replace the international standard CISPR 14-1 by GB 4343.1 which equivalently adopts the international standard;  Replace the international standard CISPR 11 by GB 4824 which equivalently adopts the international standard;  Replace the international standard IEC 60417 by GB/T 5465.2-2008 which equivalently adopts the international standard;  Replace the international standard CISPR 16-1-2 by GB/T 6113.102 which equivalently adopts the international standard;  Replace the international standard CISPR 22 by GB/T 9254 which equivalently adopts the international standard;  Replace the international standard IEC 60601-1.2005 by GB 9706.1-2020 which equivalently adopts the international standard;  Replace the international standard IEC 61000-3-2 by GB 17625.1 which equivalently adopts the international standard;  Replace the international standard IEC 61000-3-3 by GB/T 17625.2 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-2 by GB/T 17626.2 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-3 by GB/T 17626.3 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-4 by GB/T 17626.4-2018 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-5 by GB/T 17626.5 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-6.2006 by GB/T 17626.6- 2017 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-8 by GB/T 17626.8 which equivalently adopts the international standard;  Replace the international standard IEC 61000-4-11 by GB/T 17626.11 which equivalently adopts the international standard;  Replace the international standard CISPR 15 by GB/T 17743 which equivalently adopts the international standard;  Replaced the international standard IEC 60601-1-8.2006 by YY 9706.108- 2021 which modifies and adopts the international standard. This Part also made the following editorial modifications. --- Modify some arrangement formats according to GB/T 1.1-2009. Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Part was proposed by State Food and Drug Administration. This Part shall be under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration (SAC/TC 10). The historical editions replaced by this Part are as follows. --- YY 0505-2005, YY 0505-2012.

1 Scope, Object and Related Standards

This Part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS。

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document. GB 4343.1 Electromagnetic Compatibility Requirements for Household Appliances, Electric Tools and Similar Apparatus - Part 1.Emission (GB 4343.1- 2018, CISPR 14-1.2011, IDT) GB 4824 Industrial, Scientific and Medical Equipment - Radio-frequency Disturbance Characteristics - Limits and Methods of Measurement (GB 4824- 2013, CISPR 11.2010, IDT) GB/T 5465.2-2008 Graphical Symbols for Use on Electrical Equipment - Part 2. Graphical Symbols (IEC 60417 DB.2007, IDT) GB/T 6113.102 Specification for Radio Disturbance and Immunity Measuring Apparatus and Methods - Part 1-2.Radio Disturbance and Immunity Measuring Apparatus - Coupling Devices for Conducted Disturbance Measurements (GB/T 6113.102-2018, CISPR 16-1-2.2014, IDT) GB/T 9254 Information Technology Equipment - Radio Disturbance Characteristics - Limits and Methods of Measurement (GB/T 9254-2008, CISPR 22.2006, IDT) GB 9706.1-2020 Medical Electrical Equipment - Part 1.General Requirements for Basic Safety and Essential Performance (IEC 60601-1.2012, MOD) GB 17625.1 Electromagnetic Compatibility – Limits - Limits for Harmonic Current Emissions (Equipment Input Current ≤16A Per Phase) (GB 17625.1-2012, IEC 61000-3-2.2009, IDT) GB/T 17625.2 Electromagnetic Compatibility (EMC) – Limits - Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems, for Equipment With Rated Current ≤16 A Per Phase (GB/T 17625.2- 2007, IEC 61000-3-3.2005, IDT)

3 Terms and Definitions

For the purposes of this document, the terms and definitions given in GB 9706.1-2020, YY 9706.108-2021 and the following definitions apply. 3.1 (IMMUNITY) COMPLIANCE LEVEL Level less than or equal to the IMMUNITY LEVEL for which the ME EQUIPMENT or ME SYSTEM meets the requirements of the applicable subclause of 6.2. 3.2 * DEGRADATION (of performance) Undesired departure in the operational performance of ME EQUIPMENT or an ME SYSTEM from its intended performance.

4 General Requirements

ME EQUIPMENT and ME SYSTEMS shall not emit ELECTROMAGNETIC DISTURBANCES that could affect radio services, other equipment or the ESSENTIAL PERFORMANCE of other ME EQUIPMENT and ME SYSTEMS. ME EQUIPMENT and ME SYSTEMS shall have adequate IMMUNITY to be able to provide its BASIC SAFETY and ESSENTIAL PERFORMANCE in the presence of ELECTROMAGNETIC DISTURBANCES. For EMC testing, the SINGLE FAULT CONDITION requirements of the general standard do not apply.

5 Identification, Marking and Documents

ME EQUIPMENT and ME SYSTEMS that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment shall be labelled with symbol 5140 in GB/T 5465.2-2008 for non-ionizing radiation.

6 Electromagnetic Compatibility

ME EQUIPMENT and ME SYSTEMS shall be classified as group 1 or group 2 and Class A or Class B in accordance with GB 4824, based on their INTENDED USE, as specified by the MANUFACTURER, using the guidelines in Annex D. The documentation of the test shall include the test methods used to verify compliance with the requirements of this subclause and justification for any allowances of this Part used. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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