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YY 9706.241-2020

Chinese Standard: 'YY 9706.241-2020'
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YY 9706.241-2020English579 Add to Cart Days<=6 Medical electrical equipment -- Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Valid YY 9706.241-2020
YY 9706.241-2020Chinese34 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY 9706.241-2020 (YY9706.241-2020)
Description (Translated English) Medical electrical equipment -- Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.01
Word Count Estimation 32,358
Date of Issue 2020-09-27
Date of Implementation 2023-05-01
Older Standard (superseded by this standard) YY 0627-2008
Drafting Organization Zhejiang Medical Device Inspection and Research Institute
Administrative Organization National Optical and Photonics Standardization Technical Committee Medical Optics and Instrument Sub-Technical Committee (SAC/TC 103/SC 1)
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY 9706:241-2020
(Medical electrical equipment-Part 2-41: Special requirements for basic safety and basic performance of surgical shadowless lamps and diagnostic lamps)
ICS 11:040:01
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0627-2008
Medical electrical equipment-Part 2-41: Surgical shadowless lamps
And basic safety and basic performance of diagnostic lamps
Dedicated requirements
diagnosis
(IEC 60601-2-41:2013, MOD)
Released on 2020-09-27 Implemented on 2023-05-01
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
201:1 Scope, purpose and related standards 1
201:2 Normative references 2
201:3 Terms and Definitions 2
201:4 General requirements 5
201:5 General requirements for ME equipment testing 6
201:6 Classification of ME equipment and ME systems 6
201:7 ME equipment identification, marking and documentation 6
201:8 Protection of ME equipment against electric shock hazard (source) 7
201:9 Protection of ME equipment and ME systems against mechanical hazards 8
201:10 Protection against unwanted or excessive radiation risks (sources) 10
201:11 Protection against over-temperature and other hazards (sources) 10
201:12 Accuracy of controllers and instruments and protection of dangerous outputs 11
201:13 Dangerous conditions and fault states of ME equipment 21
201:14 Programmable Medical Electrical System (PEMS) 22
201:15 Structure of ME equipment 22
201:16 ME System 22
201:17 Electromagnetic compatibility of ME equipment and ME systems 22
Appendix 23
Appendix AA (informative appendix) Guidelines and rationale for special clauses and subclauses 24
Appendix BB (informative appendix) Technical differences between this part and IEC 60601-2-41:2013 and their reasons 26
Reference 28
Preface
All technical content in this section is mandatory:
The "Medical Electrical Equipment" series of standards is divided into two parts:
---Part 1: General and parallel requirements;
---Part 2: Special requirements:
This part is part 2-41:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part replaces YY 0627-2008 "Medical electrical equipment Part 2: Special requirements for the safety of surgical shadowless lamps and diagnostic lamps
Compared with YY 0627-2008, the main technical changes except for editorial changes are as follows:
---Added normative reference documents (see:201:2);
---Modified the term and definition of "beam depth" (see:201:3:203, 2:109 of YY 0627-2008);
---Modified the term "failure protection" (see:201:3:204, 2:10:101 of YY 0627-2008);
---Modified the term "detachable handle" (see:201:3:210, 2:1:101 of YY 0627-2008);
--- Added terms and definitions "single surgical shadowless lamp" (see:201:3:213);
--- Deleted the term "safety extra low voltage" (see 2:4:3 of YY 0627-2008);
--- The term "applied part" was deleted, and it was added in the form of a note in the protection against electric shock (see 2:1:5 of YY 0627-2008,:201:6:2:);
--- Added "Requirements for Special Color Rendering Index R9" (see:201:7:9:2:1);
--- Deleted the material heat resistance and flame retardant test (see 55:1 of YY 0627-2008);
---Deleted the material composition requirements [see 59:1d) of YY 0627-2008]:
This part uses the redrafting method to modify and adopt IEC 60601-2-41:2013 "Medical Electrical Equipment Part 2-41: Surgical Shadowless Lamps
And special requirements for basic safety and basic performance of diagnostic lamps:
Compared with IEC 60601-2-41:2013, there are technical differences in this part: The clauses related to these differences have been passed on the outer margins:
The vertical single line (|) in the blank position is marked, and Appendix BB gives a list of the corresponding technical differences and their reasons:
This section has made the following editorial changes:
---Term order adjustment: Adjust the serial number:201:3:204 of the term "spot center" in IEC 60601-2-41:2013 to:201:3:201, which
His serial number has been postponed: Because the "spot center" is the basic point of a series of definitions, it is strictly and orderly after adjustment, and the order is more reasonable:
---IEC 60601-2-41:2013:201:5:4 The warm-up time of other light sources does not exceed 1% according to the performance change per 100h
Determine the warm-up time, where 100h is an editorial error, and it is 10h in IEC 60601-2-41:2000, which is changed to
10h:
--- A note has been added in:201:9:5:1:101 of this part:
---A note has been added in this section:201:12:1:102:1:2:
--- The chapter number of:201:3:103 failure protection in Appendix AA is wrong, and it is changed to:201:3:204 in this section:
--- Deleted the term index after the IEC 60601-2-41:2013 reference:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part was proposed by the State Drug Administration:
This part is organized by the National Optical and Photonics Standardization Technical Committee Medical Optics and Instrument Sub-Technical Committee (SAC/TC103/
SC1) Centralized:
Drafting unit of this section: Zhejiang Medical Device Inspection and Research Institute:
The main drafters of this section: Wang Jingtao, Jia Xiaohang, He Tao, Hu Yiping, Peng Jianhua:
The previous versions of the standards replaced by this part are as follows:
---YY 0627-2008:
Medical electrical equipment-Part 2-41: Surgical shadowless lamps
And basic safety and basic performance of diagnostic lamps
Dedicated requirements
201:1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard 1) applies:
201:1:1 *Scope
replace:
This section applies to the basic safety and basic performance of surgical shadowless lamps and diagnostic lighting (hereinafter referred to as ME equipment):
This section does not apply to
---headlamp;
--- GB 9706:19 involves endoscopes, laparoscopes and their light sources;
--- YY/T 1120 related dental lighting;
---GB 7000:201 and GB 7000:204 related general lamps;
---Therapeutic lamp;
---Special light sources with special purposes, such as ultraviolet light for dermatological diagnosis, ophthalmic slit lamps, surgical microscope lights, and surgical navigation systems
All lights;
---Lights connected with surgical instruments;
--- Emergency lighting related to GB 7000:2:
Note: See 4:2 of the general standard:
201:1:2 Purpose
replace:
The purpose of this part is to specify the basic safety and basic performance of surgical shadowless lamps and diagnostic lamps that meet the definition of:201:3:
Claim:
201:1:3 Specific standards
replace:
In the GB 9706:1 series of standards, special standards can be modified, replaced or deleted according to the conditions of special ME equipment:
The requirements listed in the standards can add other basic safety and basic performance requirements:
The requirements of specific standards take precedence over the requirements of general standards:
For simplicity, in this section, GB 9706:1 is referred to as "General Standard":
The numbering method of clauses and subclauses in this part conforms to the numbering method of clauses in the general standard and is prefixed with "201" (as in this part
201:1 describes the content of Chapter 1 of the General Standard), or conforms to the numbering method of the clauses in the applicable parallel standard with the prefix "20X", which
The X refers to the last number of the parallel standard document number (for example, 202:4 in this part explains the internal part of Chapter 4 of the IEC 60601-1-2 parallel standard):
Content, 203:4 of this part describes the content of Chapter 4 of the 60601-1-3 parallel standard, and so on: By using the following word pair and general standard
The content-related changes are stipulated:
1) General standards refer to GB 9706:1, "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance":