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YY/T 1712-2021 (YYT 1712-2021)

Chinese standards (related to): 'YY/T 1712-2021'
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BASIC DATA
Standard ID YY/T 1712-2021 (YY/T1712-2021)
Description (Translated English) Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C39
Classification of International Standard 11.040
Word Count Estimation 22,223
Date of Issue 2021-03-09
Date of Implementation 2022-10-01
Drafting Organization Chinese People's Liberation Army General Hospital, Beijing SECCO Science and Technology Co., Ltd., Beijing Medical Device Inspection Institute, Shanghai Changdao Biotechnology Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd. Mike Biology Co., Ltd.
Administrative Organization National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC 10/SC 5)
Regulation (derived from) State Drug Administration Announcement No. 37 of 2021
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration


YY/T 1712-2021: PDF in English (YYT 1712-2021)
YY/T 1712-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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 
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 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
Figure 2 -- Orientation accuracy and repeatability
3.3 Positioning repeatability
The degree of consistency of the attained positions that the same command
pose arrives repeatedly n times from the same direction. The value of the
sphere radius RP1, with the cluster center as the center of the sphere, is shown
in Figure 1.
[GB/T 12642-2013, Definition 7.2.2]
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]
3.5 Master-slave operation distance accuracy
The difference between the theoretical movement distance of the end effector
reference point and the average actual movement distance under master-slave
operation.
Note: The theoretical movement distance depends on the movement distance
of the master equipment reference point and the mapping relation of the
master-slave movement.
3.6 Master-slave operation distance repeatability
The degree of consistency of the actual movement distance of the end effector
reference point, when the master equipment reference point repeatedly moves
in the same direction n times under the master-slave operation.
3.7 Master-slave operation orientation accuracy
The difference between the average orientation of the master equipment
reference frame and the average orientation of the end effector reference frame
under master-slave operation.
3.8 Master-slave operation orientation repeatability
The degree of consistency of the attained orientations of the end effector
reference frame, when the orientation of the master equipment reference frame
moves repeatedly in the same direction for n times, under master-slave
operation.
3.9 Pose
3.17 End effector
The equipment that is installed at the mechanical interface for the RA equipment
to complete its surgical tasks.
3.18 End effector reference point
The reference point that is set on the end effector for a certain purpose. In the
test, the geometric center of the last joint axis of the end effector is generally
used as the measurement reference point.
[GB/T 12643-2013/ISO 8373:2012, definition 4.9]
3.19 End effector reference frame
The reference frame that is set on the end effector for a certain purpose. During
the test, it is generally defined at the end effector reference point.
3.20 Master equipment reference point
The reference point that is set on the master equipment in order to reflect the
information of the doctor's hand operation during the operation. During the test,
the intersection of several joint axes at the end of the master equipment is
generally used as the measurement reference point.
3.21 Master equipment reference frame
The reference frame that is set on the master equipment in order to reflect the
information of the doctor's hand operation during the operation. During the test,
it is generally defined at the master equipment reference point.
3.22 Mechanical interface
The component, on the mounting surface of the RA equipment, that is allowed
to connect detachable accessories and components, or is operated by the RA
equipment movement.
Note 1: The mechanical interface can be used to attach sterile items.
Note 2: The mechanical interface can provide insulation and other functions
(such as aseptic boundaries) to meet basic security requirements.
Note 3: The RA equipment may have zero, one or more mechanical interfaces.
Note: Rewrite IEC 80601-2-77.
3.23 Master-slave control
The positioning repeatability shall meet the manufacturer's regulations in the
accompanying documents.
4.2.1.4 Orientation repeatability
The orientation repeatability shall meet the manufacturer's regulations in the
accompanying documents.
4.2.2 Master-slave operation accuracy and master-slave operation
repeatability
4.2.2.1 Master-slave operation distance accuracy
The master-slave operation distance accuracy shall meet the manufacturer's
regulations in the accompanying documents.
4.2.2.2 Master-slave operation distance repeatability
The master-slave operation distance repeatability shall meet the
manufacturer's regulations in the accompanying documents.
4.2.2.3 Master-slave operation orientation accuracy
The master-slave operation orientation accuracy shall meet the manufacturer's
regulations in the accompanying documents.
4.2.2.4 Master-slave operation orientation repeatability
The master-slave operation orientation repeatability shall meet the
manufacturer's regulations in the accompanying documents.
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.
4.3.2 RA equipment positioning repeatability under navigation guidance
The positioning repeatability shall meet the manufacturer's regulations in the
accompanying documents.
4.3.3 RA equipment system accuracy under navigation guidance
The system accuracy shall meet the manufacturer's regulations in the
accompanying documents.
damp and heat storage) and mechanical environment test (vibration test,
collision test); the final test shall be performed after all the tests are completed.
The test items of the environmental test are specified by the manufacturer, and
should include at least 4.2 Master-slave control RA equipment accuracy, and
4.3.2 RA equipment positioning repeatability under navigation guidance.
4.8 Safety requirements
In addition to the following contents which implement the requirements of this
Standard, GB 9706.1 is applicable.
6.1 External marking of equipment or equipment components
6.1v) Protective packaging
Supplement:
If the disposable applied part cannot be marked, it shall be marked on the
independent outer packaging of the applied part, or marked at the adjacent
connection point of the applied part of the RA equipment.
6.1l) Classification
Supplement:
If the RA equipment needs to be marked with IP classification, and a protective
cover is required to meet the IP classification requirements, the IP symbol shall
be marked on the protective cover.
6.8.2 Instruction manual
Supplement:
In addition to the general requirements, the following warnings and safety
instructions shall be added, if applicab......