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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
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY9706.258-2022
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PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.70
CCS C 40
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
(IEC 80601-2-58.2016, MOD)
Issued on: MAY 18, 2022
Implemented on: JUNE 01, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 5
201.1 Scope, purpose and related standards... 6
201.2 Normative references... 8
201.3 Terms and definitions... 9
201.4 General requirements... 11
201.6 Classification of ME devices and ME systems... 12
201.7 ME equipment identification, marking and documentation... 12
201.8 Protection against electric shock hazards for ME equipment... 14
201.9 Protection against mechanical hazards for ME equipment and ME systems... 14
201.10 Protection against unwanted or excessive radiation hazards (sources)... 14
201.11 Protection against overheating and other hazards... 14
201.12 Accuracy of controllers and instruments and protection against hazardous
outputs... 15
201.13 Hazardous conditions and fault states of ME equipment... 24
201.14 Programmable medical electrical systems (PEMS)... 24
201.15 Structure of ME equipment... 25
201.16 ME System... 25
201.17 Electromagnetic compatibility of ME equipment and ME systems... 25
202 Electromagnetic compatibility -- Requirements and tests... 25
Annexes... 27
Annex C (informative) Guidelines for marking and labelling requirements for medical
electrical equipment and systems... 27
Annex D (informative) Symbol marks... 29
Annex AA (informative) Special guidelines and basic principles... 30
Figure 201.101 -- Test methods for gravity injection equipment... 16
Figure 201.102 -- Test methods for pressure injection equipment... 17
Figure 201.103 -- Test method for suction negative pressure... 18
Figure 201.104 -- Test method for accuracy of high-precision ultrasonic rates... 21
Figure 201.105 -- Test method for the cutting tip rate of the vitreous body... 22
Table 201.C.101 -- Accompanying files, instructions for use of lens removal and
vitrectomy devices or components... 28
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents".
The "Medical electrical equipment" series of standards is divided into two parts.
- Part 1.General and parallel requirements;
- Part 2.Particular requirements.
This document is Part 2-58 of YY 9706 "Medical electrical equipment".
This document uses redrafting method to modify and adopt IEC 80601-2-
58.2014+Amd 1.2016 "Medical electrical equipment -- Part 2-58.Particular
requirements for basic safety and essential performance of lens removal devices and
vitrectomy devices for ophthalmic surgery".
Compared with IEC80601-2-58.2014+Amd1.2016, this document has undergone the
following structural adjustments.
- 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 the reasons therefor, are as follows.
- Regarding normative references, this document has been revised to reflect technical
differences, so as to adapt to Chinese technical conditions. The specific revisions
are reflected in "201.2 Normative references". The specific revisions are as
follows.
● CISPR 11 has been replaced by GB 4824-2019, which is equivalent to CISPR
11;
● IEC 60601-1-2 has been replaced by YY 9706.102-2021, which modifies and
adopts IEC 60601-1-2;
● IEC 60601-2-2 has been replaced by GB 9706.202, which modifies and adopts
IEC 60601-2-2;
● IEC 60601-2-22 has been replaced by GB 9706.20, which is equivalent to IEC
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
201.1 Scope, purpose and related standards
Except as described below, Chapter 1 of the General Standard applies.
201.1.1 * Scope
Replacement.
This document specifies the basic safety and performance requirements for ophthalmic
surgical lens removal and vitrectomy device.
This document applies to the basic safety and performance of ophthalmic surgical lens
removal and vitrectomy device, as well as related accessories that can be connected to
such medical electrical equipment.
If a clause or sub-clause applies only to medical electrical equipment or only to medical
electrical systems, this will be stated in the heading and content of that clause or sub-
clause. If this is not the case, then the clause or sub-clause applies to both medical
electrical equipment and medical electrical systems.
This document does not cover hazards inherent in the intended physiological function
of medical electrical equipment or systems within its scope, except for 7.2.13 and 8.4.1
of the General Standard.
NOTE. See 4.2 of the General Standard.
201.1.2 Purpose
Replacement.
The purpose of this document is to establish specific safety requirements for ophthalmic
surgical lens removal and vitrectomy devices, as well as related accessories that can be
connected to the devices and tested together or separately.
201.1.3 * Parallel standards
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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