YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotic technology
1 Scope
This standard specifies the terms and definitions, requirements, and test methods for the assisted surgical medical equipment and assisted surgical medical system employing robotic technology.
This standard is applicable to the assisted surgical medical equipment and assisted surgical medical system employing robotic technology (hereinafter referred to as "RA equipment").
2 Normative references
The following referenced 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 needle
YY 0167 Non-absorbable surgical suture
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 as well as the following apply.
3.1
positioning accuracy
difference, APp, between the position Oc approaching a command pose from the same direction and the centre of the cluster, G, of the attained positions, see Figure 1
[GB/T 12642-2013, Definition 7.2.1]
Figure 1 Positioning accuracy and repeatability
3.2
orientation accuracy
difference, APa, APb and APc, between the orientation approaching a command pose from the same direction and the mean value of the attained orientations, see Figure 2
[GB/T 12642-2013, Definition 7.2.1]
Figure 2 Orientation accuracy and repeatability
3.3
positioning repeatability
closeness of agreement between the attained positions after n repeat visits to the same command pose in the same direction, which is expressed by the value RP1, i.e., the radius of the sphere whose centre is the centre of the position cluster, see Figure 1
[GB/T 12642-2013, Definition 7.2.2]
3.4
orientation repeatability
closeness of agreement, RPa, RPb and RPc, between the attained orientations after n repeat responses to the same command pose in the same direction, see Figure 2
[GB/T 12642-2013, Definition 7.2.2]
3.5
master-slave operation distance accuracy
difference between the theoretical motion distance and the mean value of actual motion distances of the end effector reference point under master-slave operation
Note: The theoretical motion distance depends on the motion distance of the master equipment reference point and the mapping relationship of the master-slave motion.
3.6
master-slave operation distance repeatability
closeness of agreement between the actual motion distances of the end effector reference point when the master equipment reference point moves n times repeatedly in the same direction under master-slave operation
3.7
master-slave operation orientation accuracy
difference between the mean value of the orientations of the master equipment reference frame and the mean value of the orientations of the end effector reference frame under master-slave operation
3.8
master-slave operation orientation repeatability
closeness of agreement between the attained orientations of the end effector reference frame when the orientation of the master equipment reference frame moves n times repeatedly in the same direction under master-slave operation
3.9
pose
combination of position and orientation in space
Note: It normally refers to the position and orientation of the end effector or mechanical interface.
[GB/T 12643-2013/ISO 8373:2012, Definition 4.5]
Foreword I
Introduction II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Working environmental conditions
4.2 RA equipment accuracy under master-slave control
4.3 Localization accuracy of RA equipment under navigation guidance
4.4 Maximum space and effective workspace
4.5 Load carrying capacity of robotic arm
4.6 Master-slave control time delay
4.7 Environmental test
4.8 Safety requirements
5 Test methods
5.1 Working environmental conditions
5.2 RA equipment accuracy under master-slave control
5.3 Localization accuracy of RA equipment under navigation guidance
5.4 Maximum space and effective workspace
5.5 Load carrying capacity of robotic arm
5.6 Master-slave control time delay
5.7 Environmental test
5.8 Safety requirements
