YY/T 1712-2021Assisted surgical medical equipment and assisted surgical medical system employing robotic technology (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.

This standard was proposed by the National Medical Products Administration and is under the jurisdiction of the Subcommittee on Medical Electrical Equipment for Electromedicine of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 5).

Drafting organizations: Shanghai Institute of Medical Device Testing, 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 Jiao Tong 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 Jiao Tong University.

Main drafters: 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 systems employing robotic technology.

This standard applies to assisted surgical medical equipment and assisted surgical medical systems 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 edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

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 needles

YY 0167, Non-absorbable surgical sutures

YY/T 1686, Medical electrical equipment employing robotic technology - Classification

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 12642, GB/T 12643 and YY/T 1686 and the following apply.

3.1 positioning accuracy: the difference (APp) between the position of a command pose and the barycentre of the attained positions when approaching the command pose from the same direction, as shown in Figure 1. [GB/T 12642-2013, definition 7.2.1]

3.2 orientation accuracy: the difference (APa, APb, APc) between the orientation of a command pose and the average of the attained orientations when approaching the command pose from the same direction, as shown in Figure 2.

3.4 orientation repeatability: the closeness of agreement (RPa, RPb, RPc) between the attained orientations when the same command pose is repeated n times from the same direction, as shown in Figure 2. [GB/T 12642-2013, definition 7.2.2]

3.10 command pose: the pose specified by the task program to define a specific task of the RA equipment. [GB/T 12643-2013/ISO 8373:2012, definition 4.5.1]

3.11 effective operating force of the robotic arm: the force output by the robotic arm and the end effector under normal working conditions.

3.12 end effector clamping force: the clamping force at the tip of the end effector under normal working conditions.