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GB 9706.275-2022: Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
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Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
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GB 9706.275-2022
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Basic data | Standard ID | GB 9706.275-2022 (GB9706.275-2022) | | Description (Translated English) | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 26,289 | | Date of Issue | 2022-12-29 | | Date of Implementation | 2026-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.275-2022: Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
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ICS 11.040.01
CCSC40
National Standards of People's Republic of China
Medical Electrical Equipment Part 2-75.Photodynamics
Basic safety and
Basic performance-specific requirements
diagnosis equipment
Released on 2022-12-29
2026-01-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction V
201.1 Scope, purpose and related criteria1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 5
201.5 General requirements for testing of ME EQUIPMENT 5
201.6 Classification of me equipment and me systems5
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 5
201.8 Protection against electric shock hazards for ME EQUIPMENT7
201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 7
201.10 Protection against unwanted or excessive radiation hazards (sources)7
201.11 Protection against extreme temperatures and other hazards (sources)8
201.12 Accuracy of controls and instruments and protection against hazardous outputs8
201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 10
201.14 Programmable electrical medical systems (PEMS) 11
201.15 Construction of ME EQUIPMENT 12
201.16 ME system 12
201.17 Electromagnetic compatibility of me equipment and me systems12
Appendix 13
Appendix AA (Informative) General Guidelines and Rationale 14
Appendix BB (Informative) Specific Hazardous Situations and Hazards and Risk Assessment Guidelines 17
Reference 19
Table AA.1 Parameter-related characteristics 14
Table BB.1 Specific hazardous situations and hazards 17
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is part 2-75 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts.
--- Part 1.General requirements for basic safety and essential performance;
--- Part 1-3.General requirements for basic safety and essential performance Collateral standard. Radiation protection of diagnostic X-ray equipment;
--- Part 2-1.Particular requirements for the basic safety and essential performance of electron accelerators with energies ranging from 1 MeV to 50 MeV;
--- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
--- Part 2-3.Special requirements for basic safety and basic performance of short-wave therapy equipment;
--- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators;
--- Part 2-5.Particular requirements for basic safety and basic performance of ultrasonic physiotherapy equipment;
--- Part 2-6.Particular requirements for basic safety and basic performance of microwave therapy equipment;
--- Part 2-8.Particular requirements for basic safety and essential performance of therapeutic X-ray equipment with energy from 10kV to 1MV;
--- Part 2-11.Particular requirements for basic safety and essential performance of gamma beam therapy equipment;
--- Part 2-12.Particular requirements for basic safety and basic performance of critical care ventilators;
--- Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations;
--- Part 2-16.Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
--- Part 2-17.Particular requirements for basic safety and basic performance of automatically controlled brachytherapy afterloading equipment;
--- Part 2-18.Particular requirements for basic safety and essential performance of endoscopic equipment;
--- Part 2-19.Particular requirements for basic safety and basic performance of infant incubators;
--- Part 2-22.Special requirements for basic safety and essential performance of laser equipment for surgery, plastic surgery, therapy and diagnosis;
--- Part 2-24.Particular requirements for basic safety and essential performance of infusion pumps and infusion controllers;
--- Part 2-25.Specific requirements for basic safety and basic performance of electrocardiographs;
--- Part 2-26.Special requirements for basic safety and basic performance of EEG machines;
--- Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment;
--- Part 2-28.Particular requirements for basic safety and essential performance of medical diagnostic X-ray tube assemblies;
--- Part 2-29.Particular requirements for basic safety and basic performance of radiotherapy simulators;
--- Part 2-36.Particular requirements for the basic safety and essential performance of in vitro induced lithotripsy equipment;
--- Part 2-37.Particular requirements for basic safety and essential performance of ultrasonic diagnostic and monitoring equipment;
--- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment;
--- Part 2-43.Particular requirements for basic safety and essential performance of X-ray equipment for interventional operation;
--- Part 2-44.Particular requirements for basic safety and essential performance of X-ray computed tomography equipment;
--- Part 2-45.Particular requirements for basic safety and basic performance of mammography equipment and mammography stereotaxic devices;
--- Part 2-54.Special requirements for basic safety and basic performance of X-ray photography and fluoroscopy equipment;
--- Part 2-55.Particular requirements for basic safety and basic performance of respiratory gas monitors;
--- Part 2-60.Particular requirements for basic safety and essential performance of dental equipment;
--- Part 2-63.Particular requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging;
--- Part 2-65.Particular requirements for basic safety and basic performance of dental X-ray machines for intraoral imaging;
--- Part 2-71.Particular requirements for basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment;
--- Part 2-75.Particular requirements for basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment;
--- Part 2-83.Particular requirements for the basic safety and essential performance of household phototherapy equipment;
--- Part 2-90.Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment.
This document is modified to adopt IEC 60601-2-75.2017 "Medical Electrical Equipment Part 2-75.Photodynamic Therapy and Photodynamic Diagnostic Equipment
Particular Requirements for Basic Safety and Essential Performance of Equipment".
Compared with IEC 60601-2-75.2017, this document has made the following structural adjustments.
---.201.12.1.108 "Aiming" corresponds to.201.12.1.107 "Aiming" in IEC 60601-2-75.2017.
The technical differences between this document and IEC 60601-2-75.2017 and their reasons are as follows.
--- Replaced IEC 60601-1.2012 (see.201.2) with the normative reference GB 9706.1-2020, the consistency between the two documents
The degree of sex is modified to suit the national conditions of our country;
--- Replaced IEC 60601-2-22.2012 with the normative reference GB 9706.222-2022 (see.201.2,.201.7.2.101,
adapt to the national conditions of our country;
--- Replaced IEC 60601-2-57.2011 with the normative reference YY9706.257-2021 (see.201.2,.201.6,.201.7.2.101,
national conditions;
--- Replaced IEC 60825-1.2014 with the normative reference GB 7247.1-2012 (see.201.2,.201.6,.201.7.9.2.2,
--- Replaced IEC 62471.2006 (see.201.2,.201.6,.201.7) with the normative reference GB/T 20145 to adapt to my country's
national conditions;
--- Replaced IEC 62304.2006 (see.201.2,.201.14.6) with the normative reference YY/T 0664 to adapt to my country's
national conditions;
--- Added "output uniformity" to further ensure the safety and effectiveness of photodynamic therapy and diagnostic equipment (see.201.12.1.107).
The following editorial changes have been made to this document.
--- Changed "References";
--- Removed "Index of defined terms".
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the State Drug Administration.
Introduction
Safety standards for medical electrical equipment, also known as the 9706 series of standards, consist of general standards, collateral standards, specific standards, guidelines and interpretations.
---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this
Basic standard requirements.
--- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special
It is only the equipment that needs to meet the requirements of such standards.
---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards
standard.
---Guidelines and interpretations. explanations for the application guidelines and clauses of the relevant requirements in the standards involved.
In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows.
--- Part 2-66.Particular requirements for basic safety and essential performance of hearing devices and hearing device systems. The purpose is to build listening
Particular requirements for basic safety and essential performance of equipment and hearing device systems.
This document deals with basic safety and essential performance requirements for photodynamic therapy and photodynamic diagnostic equipment. This document has been amended and supplemented by
GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance".
Items marked with an asterisk (*) in this document have specific guidelines and rationale related to the project in Appendix AA. Appendix AA
Relevant content not only contributes to the correct application of this document, but also speeds up the revision of the standard due to changes in clinical practice or technical development in a timely manner.
standard process. Appendix BB gives guidance on specific hazardous situations and hazard and risk assessment.
Medical Electrical Equipment Part 2-75.Photodynamics
Basic safety and
Basic performance-specific requirements
201.1 Scope, purpose and relevant standards
Except as described below, Chapter 1 of the general standard applies.
201.1.1 Scope
replace.
This document applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment.
If a chapter or clause applies only to me equipment or me systems, the title and content of the chapter or clause will clearly state this. no
Then, this clause or subclause applies to both ME EQUIPMENT and ME SYSTEMS.
With the exception of 7.2.13 and 8.4.1 of the general standard, specific requirements within the scope of this document do not cover the intended physiological
The inherent danger of functions (source).
NOTE. See 4.2 of the general standard.
This document applies to photodynamic therapy and photodynamic diagnostic equipment for the elimination or alleviation of disease, injury or disability.
For combined equipment (for example, equipment that provides additional functions or application parts for the target area), the added functions of these equipment shall also comply with
All specific standards complying with the corresponding safety requirements.
This document does not apply to.
● Light therapy equipment for photothermal ablation, coagulation and hyperthermia;
● low-intensity laser therapy equipment not used in conjunction with photosensitizers;
● Lighting equipment for observation, monitoring and diagnosis, but not used in conjunction with photosensitizers.
201.1.2 Purpose
replace.
The purpose of this document is to specify specific requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment.
201.1.3 Collateral Standards
Supplement.
All Collateral Standards shall be considered as additions to the General Standard. Unless modified in the text of this document, all collateral standards are
apply to this document.
201.1.4 Particular standards
replace.
In the GB 9706 series, specific standards may modify, replace or delete the requirements contained in general standards or collateral standards to apply to all
Considered ME EQUIPMENT, and may increase other basic safety and essential performance requirements.
The requirements of a particular standard take precedence over those of a general standard.
In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective document numbers.
The numbering of chapters and clauses in this document corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this document corresponds to the general standard
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