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YY 9706.262-2021 English PDF (YY9706.262-2021)

YY 9706.262-2021 English PDF (YY9706.262-2021)

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YY 9706.262-2021: Medical electrical equipment -- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment

YY 9706.262-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 41
Medical Electrical Equipment – Part 2-62: Particular
Requirements for the Basic Safety and Essential
Performance of High Intensity Therapeutic Ultrasound
(HITU) Equipment
(IEC 60601-2-62:2013, MOD)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: MAY 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
201.1 Scope, Object and Collateral Standards ... 6
201.2 Normative References ... 8
201.3 Terms and Definitions ... 9
201.4 General Requirements ... 24
201.5 General Requirements for Testing of ME EQUIPMENT ... 26
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 26
201.7 ME EQUIPMENT Identification, Marking and Documents ... 26
201.8 Protection against Electrical HAZARDS from ME EQUIPMENT ... 29
201.9 Protection against Mechanical Hazards of ME EQUIPMENT and ME SYSTEMS ... 30
201.10 Protection against Unwanted and Excessive Radiation HAZARDS ... 30 201.11 Protection against excessive temperatures and other HAZARDS ... 33 201.12 Accuracy of controls and instruments and protection against hazardous outputs ... 34
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT .. 36 201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 36
201.15 Construction of ME EQUIPMENT ... 37
201.16 ME systems ... 37
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37 202 Electromagnetic Compatibility – Requirements and Tests ... 37
Annexes ... 42
Annex AA (Informative) Particular Guidance and Rationale ... 42
Annex BB (Informative) Targeting ... 47
Annex CC (Informative) HITU - Specific Risks ... 51
Annex DD (Informative) Determining Regions of HITU Fields for Measurement ... 56 Annex EE (Informative) Guidance in classification according to GB 4824-2019 ... 69 Annex FF (Informative) Notes on Using a Saline or Water Bath for EMI Testing ... 70 Bibliography ... 73
Foreword
All the technical contents of this Part are mandatory.
Medical Electrical Equipment serial standards are divided into two parts: --- Part 1: General and Collateral Requirements;
--- Part 2: Particular Requirements.
This Part is Part 2-62.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part uses the redrafting method to modify and adopt IEC 60601-2-62:2013 Medial Electrical Equipment – Part 2-62: Particular Requirements for the Basic Safety and Essential Performance of High Intensity Therapeutic Ultrasound (HITU) Equipment.
The technical differences and the causes between this Part and IEC 60601-2-62:2013 are as follows:
--- Regarding Normative References, this Part has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are concentrated in Clause 2, "Normative References". The specific adjustments are as follows:
 Use YY/T 0642 that equivalently adopts the international standard to replace IEC 62359 (see 201.2);
 Use YY/T 0750-2018 that modifies and adopts the international standard to replace IEC 61689:2013 (see 201.2);
 Use YY/T 0865.1 that equivalently adopts the international standard to replace IEC 62127-1 (see 201.2);
 Use YY/T 0865.2 that equivalently adopts the international standard to replace IEC 62127-2 (see 201.2).
This Part made the following editorial modifications as follows:
--- Deleted the content of reference [3-10] mentioned in the NOTE of the Normative References;
--- According to the numbering rules for annexes in the text of the Standard, modify Annex A to Annex AA;
--- According to the numbering rules for annexes in the text of the Standard, modify Annex Medical Electrical Equipment – Part 2-62: Particular
Requirements for the Basic Safety and Essential
Performance of High Intensity Therapeutic Ultrasound
(HITU) Equipment
201.1 Scope, Object and Collateral Standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Addition:
This Part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT (hereafter referred to as ME EQUIPMENT).
This Part adds or replaces particular clauses listed in the GB 9706.1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause shall say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this Part are not covered by specific requirements in this Part except in 7.2.13 and 8.4.1 of the general standard.
NOTE 1: See also 4.2 of the general standard.
NOTE 2: As, in HITU fields, the acoustic waveform is expected to be extremely distorted due to non- linear propagation effects, the ultrasonic measurements are to be made under quasi linear conditions and then extrapolated following procedures given in IEC/TS 62556. See also IEC/TS 61949. NOTE 3: An asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines and rationale related to the item in Annex AA. This Part can also be applied to:

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