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Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment
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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
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PHARMACEUTICAL INDUSTRY STANDARD
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
D to Annex DD;
--- Add some NOTE to this Part.
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 National Medical Products Administration.
This Part shall be under the jurisdiction of Subcommittee of Medical Ultrasound Equipment of
National Technical Committee on Medical Electrical Equipment of Standardization
Administration of China (SAC/TC 10/SC 2).
Drafting organizations of this Part. Hubei Institute of Medical Device Quality Supervision and
Testing; Chongqing Haifu Medical Technology Co., Ltd.; and Wuxi Haiying Electronic
Medical System Co., Ltd.
Chief drafting staffs of this Part. Jiang Shilin, Ye Fangwei, Wang Guoying, and Xu Yang.
201.1 Scope, Object and Collateral Standards
Clause 1 of the general standard applies, except as follows.
201.2 Normative References
Clause 2 of the general standard applies, except as follows.
Replacement.
201.3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB 9706.1, YY/T 0642,
YY/T 0865.1 and YY/T 0750 and the following apply.
201.4.11 POWER INPUT
Addition.
This clause of the general standard applies with EQUIPMENT operated at maximum OUTPUT
POWER.
201.5 General Requirements for Testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT Identification, Marking and
Documents
Clause 7 of the general standard applies, except as follows.
Addition.
201.8 Protection against Electrical HAZARDS from ME
EQUIPMENT
Clause 8 of the general standard applies, except as follows.
201.9 Protection against Mechanical Hazards of ME
EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against Unwanted and Excessive Radiation
HAZARDS
Clause 10 of the general standard applies, except as follows.
201.11 Protection against excessive temperatures and other
HAZARDS
Clause 11 of the general standard applies, except as follows.
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
Clause 12 of the general standard applies, except as follows.
201.13 HAZARDOUS SITUATIONS and fault conditions for
ME EQUIPMENT
Addition.
201.14 Programmable ELECTRICAL MEDICAL SYSTEMS
(PEMS)
Clause 14 of the general standard applies
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies
201.16 ME systems
Clause 16 of the general standard applies
201.17 * Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
Clause 17 of the general standard applies except as follows.
Addition.
202 Electromagnetic Compatibility – Requirements and Tests
YY 9706.102 applies, except as follows.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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