YY 9706.258-2022_English: PDF (YY9706.258-2022)
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Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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YY 9706.258-2022
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Standards related to: YY 9706.258-2022
| Standard ID | YY 9706.258-2022 (YY9706.258-2022) | | Description (Translated English) | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 24,259 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2025-06-01 | | Administrative Organization | National Optical and Photonics Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC 103/SC 1) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies specific requirements for the basic safety and basic performance of lens extraction and vitrectomy equipment for ophthalmic surgery. This standard applies to the basic safety and basic performance of lens extraction and vitrectomy equipment for ophthalmic surgery, as well as related accessories that can be connected to the medical electrical equipment. | YY 9706.258-2022
Medical electrical equipment - Part 2-58.Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
ICS 11.040.70
CCSC40
People's Republic of China Pharmaceutical Industry Standard
Medical Electrical Equipment Part 2-58.Ophthalmic Surgery
Basics of using lens extraction and vitrectomy equipment
Specific requirements for safety and essential performance
Published on 2022-05-18
2025-06-01 Implementation
Released by the State Drug Administration
directory
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 4
201.5 General Requirements for ME EQUIPMENT Testing 5
201.6 Classification of ME EQUIPMENT and ME SYSTEM 5
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENT 5
201.8 ME EQUIPMENT PROTECTION TO ELECTRIC SHOCK HAZARD 6
201.9 Protection of me equipment and me systems against mechanical hazards 6
201.10 Protection against unwanted or excessive radiation hazards (sources) 6
201.11 Protection against ultra-temperature and other hazards (sources) 6
201.12 Accuracy of controls and instruments and protection of hazardous outputs 6
201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAILURE STATES 12
201.14 Programmable Medical Electrical System (PEMS) 13
201.15 Structure of ME equipment 13
201.16 ME System 13
201.17 Electromagnetic compatibility of me equipment and me systems 13
202 Electromagnetic compatibility - requirements and tests 13
Appendix 14
Appendix C (Informative) Guidelines for Marking and Labeling Requirements for Medical Electrical Equipment and Medical Electrical Systems 14
Appendix D (Informative) Symbols 15
Appendix AA (Informative) Special Guidelines and Rationale 16
Figure.201.101 Test Method for Gravity Infusion Equipment 7
Figure.201.102 Test method for pressure perfusion equipment 8
Figure.201.103 Test method for suction negative pressure 8
Figure.201.104 Test Method for Ultrasonic Velocity Accuracy at Tip 10
Figure.201.105 Test Method for Vitreous Cutting Tip Rate 11
Table.201.C.101 Random Documents, Instructions for Use of Lens Removal and Vitrectomy Devices or Components14
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 of Standardization Documents"
drafted.
The "Medical Electrical Equipment" series of standards is divided into two parts.
--- Part 1.General and side-by-side requirements;
--- Part 2.Specific requirements.
This document is part 2-58 of YY 9706 "Medical Electrical Equipment".
This document adopts the redrafting method to modify and adopt IEC 80601-2-58.2014 Amd1.2016 "Medical Electrical Equipment Part 2-58"
Part. Special requirements for basic safety and basic performance of lens extraction and vitrectomy equipment for ophthalmic surgery.
This document has the following structural adjustments compared to IEC 80601-2-58.2014 Amd1.2016.
---202.5.2.2.3 corresponds to 202.5.2.2 in IEC 80601-2-58.2014 Amd1.2016;
---202.5.2.2.6 corresponds to 202.5.2.2.4 in IEC 80601-2-58.2014 Amd1.2016;
---202.6.1.1 corresponds to 202.7 in IEC 80601-2-58.2014 Amd1.2016;
---202.6.2.10 corresponds to 202.8 in IEC 80601-2-58.2014 Amd1.2016.
The technical differences between this document and IEC 80601-2-58.2014 Amd1.2016 and their reasons are as follows.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The specific situation is reflected in the "201.2 Normative Reference Documents", and the specific adjustments are as follows.
● Replace CISPR11 with GB 4824-2019 which is equivalent to adopting international standards;
● Replacing IEC 60601-1-2 with YY 9706.102-2021, which is an international standard;
● The IEC 60601-2-2 is replaced by GB 9706.202 which is modified to adopt the international standard;
● Replace IEC 60601-2-22 with GB 9706.20 which is equivalent to adopting international standards;
● Replacing ISO 17664.2017 with YY/T 0802 which has been modified to adopt international standards;
● Replaced ISO 11607-2.2006/AMD1.2014 and ISO 11067-1.2006/ with "Pharmacopoeia of the People's Republic of China"
AMD1.2014;
● Added YY 0792.2-2010;
--- Based on the operability of the standard and the operability of the method, the IEC standard.201.11.6.7 Medical Electrical Equipment and Medical
The content of the sterilization clauses of the electrical system to adapt to the technical conditions of our country;
---Because few foreign products have the function of liquefaction and crushing, and the domestic phacoemulsifier does not have this function, the IEC standard.201.12.1.101.8,.201.12.1.101.8,
--- Changed the content of clause.201.12.1.101.9 in the IEC standard and added a measurement method. Using a laser to irradiate the cutter head,
The measuring device is located behind the cutter head, collects the signal after the laser penetrates the vibrating cutter head, displays the measurement signal on the oscilloscope, and reads the signal by reading
The frequency of the signal period is measured to adapt to the technical conditions of our country.
The following editorial changes have also been made to this document.
--- Deleted the terms and definitions index and bibliography section in the IEC standard;
--- Delete the descriptions of index numbers ③ and ⑦ in Figure.201.101;
--- Delete the description of the index number in Figure.201.102 ③ and ⑨;
--- Changed the title names for 202.6.1.1 and 202.6.2.10.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is sponsored by the Medical Optics and Instruments Subcommittee of the National Optical and Photonics Standardization Technical Committee (SAC/TC103/SC1)
focal point.
introduction
Lens extraction devices and vitrectomy devices are widely used in ophthalmology to perform surgery on the anterior and posterior segments of the human eye. these medical
Gas equipment began its commercial use in the early 1970s. This document defines the basic safety and
Specific requirements for basic performance, including equipment consoles, surgical handpieces, and accessories for connection to medical electrical equipment.
Ophthalmologists in many countries will use a lens extraction device in combination with a vitrectomy device in order to remove the anterior segment (lens extraction)
Combined with posterior segment surgery (vitrectomy) to maximize surgical outcomes. Therefore, lens extraction devices and vitrectomy devices
equipment are covered in this document.
Since all parts of the GB 9706 series are based on the general standard GB 9706.1, users of this standard should be reminded that the risk
Administration plays an important role in the use of this section. Projects that meet the requirements of this section shall be recorded in the risk management document to
Make sure that the hazards associated with the product have been adequately considered.
Guidance and rationale for the requirements of this document are given in Appendix AA. An asterisk (*) at the beginning of the title indicates that appendix AA contains
Guidance or rationale related to the project.
Medical Electrical Equipment Part 2-58.Ophthalmic Surgery
Basics of using lens extraction and vitrectomy equipment
Specific requirements for safety and essential performance
201.1 Scope, Purpose and Related Standards
Except as described below, Chapter 1 of the General Standard applies.
201.1.1 *Scope
replace.
This document specifies specific requirements for the essential safety and essential performance of lens extraction and vitrectomy devices for ophthalmic surgery.
This document applies to the basic safety and essential performance of lens extraction and vitrectomy devices for ophthalmic surgery, as well as the
Related accessories for the connection of electrical equipment.
If a clause or sub-clause applies only to medical electrical equipment, or to medical electrical systems only, the headings of the clause or sub-clause and
The content will explain. If this is not the case, the clause or sub-clause applies to both medical electrical equipment and medical electrical
system.
This document does not cover hazards inherent in the intended physiological function of medical electrical equipment or systems within the scope of application, the general standard
Except 7.2.13 and 8.4.1.
Note. See 4.2 of the general standard.
201.1.2 Purpose
replace.
The purpose of this document is to establish a lens extraction and vitrectomy device for ophthalmic surgery, as well as a device that can be connected and cooperable with the device.
Safety-specific requirements for related accessories to be tested together or separately.
201.1.3 *Tie standard
Added.
This document refers to Chapter 2 of the General Standard, the General Standard and those applicable collateral standards listed in.201.2 of this document.
Chapter 202 of YY 9706.102-2021 applies to this document after modification. GB 9706.103-2020, YY/T 9706.110-
2021, YY 9706.111-2021 and YY 9706.112-2021 do not apply.
201.1.4 Particular standards
replace.
In the GB 9706 series of standards, this document can be changed, replaced or deleted in the general standards and collateral standards regarding the
requirements for medical electrical equipment, and may supplement other safety-specific requirements.
Clause requirements in specific standards have priority over general standards.
In this document, GB 9706.1 is cited as a general standard.
Collateral standards are cited by their document numbers.
The chapter and subclause numbers of this document correspond to the chapters and subclauses of the general standard, prefixed with "201" (for example,.201.1 in this document refers to the general standard
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