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YY 9706.241-2020 English PDF

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US$599.00 · In stock
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YY 9706.241-2020: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 9706.241-2020	599	Add to Cart	6 days	Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis	Valid

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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: 32,327
Date of Issue: 2020-09-27
Date of Implementation: 2023-05-01
Older Standard (superseded by this standard): YY 0627-2008
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

YY 9706.241-2020: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(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

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

Foreword

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": ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 9706.241-2020_English be delivered?

Answer: Upon your order, we will start to translate YY 9706.241-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 9706.241-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY 9706.241-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.