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YY/T 1712-2021 PDF English

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YY/T 1712-2021: Assisted surgical medical equipment and assisted surgical medical system employing robotic technology
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YY/T 1712-2021: Assisted surgical medical equipment and assisted surgical medical system employing robotic technology


---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/YYT1712-2021
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 C 39 Assisted surgical medical equipment and assisted surgical medical system employing robotic technology Issued on. MARCH 09, 2021 Implemented on. OCTOBER 01, 2022 Issued by. National Medical Products Administration

Table of Contents

Foreword... 3 Introduction... 4 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 6 4 Requirements... 10 4.1 Working environment conditions... 10 4.2 Master-slave control RA equipment accuracy... 10 4.3 RA equipment positioning accuracy under navigation guidance... 11 4.4 Maximum space and effective workspace... 12 4.5 Load bearing capacity of robotic arm... 12 4.6 Master-slave control time delay... 12 4.7 Environmental test... 12 4.8 Safety requirements... 13 5 Test methods... 14 5.1 Working environment conditions... 14 5.2 Master-slave control RA equipment accuracy... 14 5.3 RA equipment positioning accuracy under navigation guidance... 24 5.4 Maximum space and effective workspace... 27 5.5 Mechanical load bearing capacity... 29 5.6 Master-slave control time delay... 30 5.7 Environmental test... 32 5.8 Safety requirements... 32

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of Subcommittee 5 on Electromedical Equipment of National Technical Committee 10 on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 5). The drafting organizations of this Standard. Shanghai Medical Device Testing Institute, Chongqing Jinshan Science & Technology (Group) Co., Ltd., Beijing TINAVI Medical Technologies Co., Ltd., Shanghai Microport Medical (Group) Co., Ltd., Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai United Imaging Healthcare Co., Ltd., Tianjin University, CCIC-CSA International Certification Co., Ltd. Shanghai Branch, Chinese PLA General Hospital, Shanghai Jiaotong University. The drafters of this Standard. He Jun, He Chao, Hong Wei, Wang Liao, Zhao Yongqiang, Chai Gang, Wang Yun, Xing Yuan, Kuang Zhao, He Kunlun, Xu Kai, Zhang Xiaoli, Zhang Weijun, Dai Tingping, Tang Peifu.

1 Scope

This Standard specifies the terms and definitions, requirements and test methods for assisted surgical medical equipment and assisted surgical medical system employing robotic technology. This Standard applies to assisted surgical medical equipment and assisted surgical medical system employing robotic technology (hereinafter referred to as "RA equipment").

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.1, Medical electrical equipment - Part 1.General requirements for basic safety and essential performance GB/T 12642, Industrial robots - Performance criteria and related test methods GB/T 12643, Robots and robotic devices - Vocabulary GB/T 14710, Environmental requirement and test methods for medical electrical equipment YY/T 0043, Medical suture needle YY 0167, Non-absorbable surgical suture YY/T 1686, Medical electrical equipment employing robotic technology - Classification

3 Terms and definitions

Terms and definitions determined by GB/T 12642, GB/T 12643, YY/T 1686, and the following ones are applicable to this document. 3.1 Positioning accuracy The difference (APp) between the position Oc approaching a certain command pose from the same direction and the attained position cluster center G, which is shown in Figure 1. [GB/T 12642-2013, definition 7.2.1] Figure 1 -- Positioning accuracy and repeatability 3.2 Orientation accuracy The difference (APa, APb, APc) between the orientation approaching a certain command pose from the same direction and the attained orientation average, which is shown in Figure 2. 3.4 Orientation repeatability The degree of consistency of the attained orientations that the same command pose responses repeatedly n times from the same direction (RPa, RPb, RPc), which is shown in Figure 2. [GB/T 12642-2013, Definition 7.2.2] 3.10 Command pose The pose that is given by the motion program that is worked out in order to define the specific tasks of the RA equipment. [GB/T 12643-2013/ISO 8373.2012, definition 4.5.1] 3.11 Effective operation force of robotic arm Under normal working conditions, the force that is output by the robotic arm and the end effector. 3.12 End effector clamping force Under normal working conditions, the clamping force of the front end of the end effector.

4 Requirements

4.1 Working environment conditions Unless otherwise specified by the manufacturer, the working environment conditions of RA equipment shall meet. 4.2 Master-slave control RA equipment accuracy 4.2.1 Pose accuracy and pose repeatability 4.2.2 Master-slave operation accuracy and master-slave operation repeatability 4.3 RA equipment positioning accuracy under navigation guidance 4.3.1 RA equipment positioning accuracy under navigation guidance The positioning accuracy shall meet the manufacturer's regulations in the accompanying documents. 4.4 Maximum space and effective workspace 4.4.1 Maximum space The maximum space shall meet the manufacturer's regulations in the accompanying documents. 4.4.2 Effective workspace The effective workspace shall meet the manufacturer's regulations in the accompanying documents. 4.5 Load bearing capacity of robotic arm 4.5.1 Effective operation force of robotic arm The effective operation force of robotic arm shall meet the manufacturer's regulations in the accompanying documents. 4.6 Master-slave control time delay The master-slave control time delay shall meet the manufacturer's regulations in the accompanying documents. 4.7 Environmental test Except for the special components (such as batteries) otherwise specified by the manufacturer's declaration, the RA equipment shall at least meet the requirements of the climatic environmental condition group I and the mechanical environmental condition group I in GB/T 14710. 4.8 Safety requirements In addition to the following contents which implement the requirements of this Standard, GB 9706.1 is applicable.

5 Test methods

5.1 Working environment conditions It shall be in accordance with 4.1. 5.2 Master-slave control RA equipment accuracy 5.2.1 Pose accuracy and pose repeatability 5.2.1.2 Positioning accuracy The positioning accuracy of the RA equipment can be obtained by the following measurements and calculations. 5.2.1.3 Positioning repeatability The positioning repeatability of the RA equipment can be obtained by the following measurements and calculations. 5.3.3 RA equipment system accuracy under navigation guidance Test requirements for the RA equipment system accuracy under navigation guidance. 5.6 Master-slave control time delay Test requirements for the master-slave control time delay of the RA equipment. 5.7 Environmental test Perform in accordance with the regulations of GB/T 14710. 5.8 Safety requirements The safety test requirements are carried out in accordance with the provisions of GB 9706.1. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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