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YY/T 1941-2024 English PDF

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US$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1941-2024: Robotically-assisted laparoscopic surgical system
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1941-2024	519	Add to Cart	5 days	Robotically-assisted laparoscopic surgical system	Valid

Similar standards

YY/T 1694 YY/T 1711 YY/T 1537 YY/T 1307 YY/T 1944

Basic data

Standard ID: YY/T 1941-2024 (YY/T1941-2024)
Description (Translated English): Robotically-assisted laparoscopic surgical system
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040
Word Count Estimation: 26,214
Date of Issue: 2024-09-29
Date of Implementation: 2025-10-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the technical requirements for laparoscopic surgical systems using robotic technology and specifies the corresponding test methods. This standard applies to laparoscopic surgical systems using robotic technology and robotic surgical instruments connected through interactive conditions and interface conditions. This standard does not apply to laparoscopic single-port surgical systems.

YY/T 1941-2024: Robotically-assisted laparoscopic surgical system

---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.
ICS 11.040 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Laparoendoscopic surgery system using robotic technology Released on 2024-09-29 Implementation on October 15, 2025 The State Drug Administration issued

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 2 4.1 Manual Controller Performance 2 4.2 Instrument Manipulator Performance 3 4.3 System Operation Performance 3 4.4 Security protection function 4 4.5 Robotic surgical instruments 5 4.6 Software 7 5 Test methods 7 5.1 Manual Controller Performance 7 5.2 Instrument Manipulator Performance 7 5.3 System Operation Performance 9 5.4 Security protection function 15 5.5 Robotic surgical instruments 16 5.6 Software 18 References 19

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. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the medical robot standardization technical authority. This document was drafted by. China Food and Drug Inspection Institute, National Medical Products Administration Medical Device Technical Evaluation Center, Shanghai Medical Device Inspection Institute, Liaoning Medical Device Inspection Institute, Sichuan Drug Inspection Institute (Sichuan Medical Device Inspection Center Center), Beijing Surui Robotics Co., Ltd., Tianjin University, Shanghai Microport Medical Robotics (Group) Co., Ltd., Intuitive Fosun Medical Medical Device Technology (Shanghai) Co., Ltd., Harbin Sizhe Rui Intelligent Medical Equipment Co., Ltd., Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. Shenzhen Kangnuo Siting Technology Co., Ltd., Ximeian Surgical Instruments Co., Ltd., Ruilong Nuofu (Shanghai) Medical Technology Co., Ltd., Guangdong Jiahuamei Certification Co., Ltd., Suzhou Kangduo Robotics Co., Ltd., Beijing Medical Device Inspection Institute, Chongqing Jinshan Medical Machine PEOPLE LIMITED. The main drafters of this document are. Meng Xiangfeng, Li Jingli, Jin Lukai, Zhang Longda, Yang Wenlong1), Hong Wei, Chen Min, Wang Zerui, Wang Gang, Liu Lili, He Chao, Xu Kai, Wang Wei, Gu Yi, Sun Xiao, Xing Yuan, Kuang Chao, Zhang Yang, Yang Chenxu, Wang Hao, Yang Wenlong2), Zhang Chao, Wang Liao. 1) Sichuan Provincial Institute of Drug Control (Sichuan Provincial Medical Device Testing Center). 2) Suzhou Kangduo Robotics Co., Ltd.

Introduction

Since the application scope and technology of this field are still developing, the technical characteristics and test methods specified in this document can only be based on the existing New technologies and methods (such as single-port surgical systems) that are adopted after full consideration of risks should not be excluded from this document. In these cases, the contents of this document should be used as a helpful guide and reference, but should not be used as a mandatory specification. As new product technologies and methods mature, this document will also revise the requirements and methods. Laparoendoscopic surgery system using robotic technology

1 Scope

This document specifies the technical requirements for laparoscopic surgical systems using robotic technology and describes the corresponding test methods. This document applies to laparoscopic surgical systems using robotics technology, as well as machines connected through interaction conditions and interface conditions. Robotic surgical instruments. This document does not apply to laparoscopic single-port surgical systems.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 4340.1 Vickers hardness test for metallic materials Part 1.Test method GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods YY/T 0043 Medical Suture Needle YY/T 0149 Test method for corrosion resistance of stainless steel medical devices YY 0167 Non-absorbable surgical suture YY/T 1686 Terminology, definitions and classification of medical electrical equipment using robotic technology YY/T 1712 Assisted surgical equipment and assisted surgical systems using robotic technology YY 9706.277 Medical electrical equipment Part 2-77.Basic safety and basic requirements for surgical assistance equipment using robotic technology Performance-specific requirements Pharmacopoeia of the People's Republic of China 2020 Edition Volume IV

3 Terms and definitions

The terms and definitions defined in GB 9706.1, YY/T 1712, YY/T 1686, YY 9706.277 and the following apply to this document. 3.1 A laparoscopic surgical device/system using robotic technology, which is expected to control robotic surgical instruments through master-slave operation and/or endoscope, while viewing through the endoscope. Note. RALS usually includes a doctor's console, a patient surgical platform, an image processing platform, a three-dimensional laparoscopic endoscope (abbreviated as endoscope), and a robotic surgical instrument. Machinery, etc. 3.2 A mechanical structure used to capture or record operator's hand movements. Note. Also called the master hand. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1941-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1941-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1941-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1941-2024_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.