YY/T 1712-2021_English: PDF (YY/T1712-2021)
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Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology
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YY/T 1712-2021
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| 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
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 applicable:
1) Warning: If the RA equipment is an F-type applied part, then, the applied
part of other medical electrical equipment that is used in conjunction with
this RA equipment shall be BF-type or CF-type;
2) Warning: When other ME equipment is used with surgical tools of the RA
equipment, patient leakage current may be superimposed;
3) Warning: When the RA equipment is used with laser equipment, advice
on its safe use shall be provided, including avoiding potential injuries, such
as wearing appropriate personal protective equipment, or inserting
appropriate filters for the surgical tools of the RA equipment;
f) The result shall meet the requirements of 4.3.1.
5.3.2 RA equipment positioning repeatability under navigation guidance
Test requirements for RA equipment positioning repeatability under navigation
guidance:
a) Connect and start the RA equipment according to the requirements of the
manual;
b) Install the calibration finger on the end mechanism as required; control the
movement of the RA equipment to place the calibration finger measuring
point at any position A in the effective workspace; use a three-dimensional
measuring instrument to measure the position coordinates A0 (XA0, YA0, ZA0)
of the current calibration finger measuring point;
c) Control the movement of the RA equipment, so that the calibration finger
measuring point is placed at any different position B in the effective
workspace; use the software to record the current pose of the RA equipment;
use a three-dimensional measuring instrument to measure the position
coordinates of the current calibration finger measuring point B0 (XB0, YB0, ZB0);
d) Control the movement of the RA equipment to move the calibration finger
measuring point to the position A; record the position coordinate A1 (XA1, YA1,
ZA1) again in the same way;
e) Control the movement of the RA equipment to move the calibration finger
measuring point to the position B; record the position coordinate B1 (XB1, YB1,
ZB1) again in the same way;
f) Repeat steps d) and e) to obtain position coordinates Ai (XAi, YAi, ZAi) and Bi
(XBi, YBi, ZBi), i = 1, 2, 3, 4, 5;
g) Calculate the spatial distance AOAi =
ඥሺ𝑋𝐴𝑂 െ 𝑋𝐴𝑖ሻ2 ሺ𝑌𝐴𝑂 െ 𝑌𝐴𝑖ሻ2 ሺ𝑍𝐴𝑂 െ 𝑍𝐴𝑖ሻ2 , BOBi =
ඥሺ𝑋𝐵𝑂 െ 𝑋𝐵𝑖ሻ 2 ሺ𝑌𝐵𝑂 െ 𝑌𝐵𝑖ሻ2 ሺ𝑍𝐵𝑂 െ 𝑍𝐵𝑖ሻ2 , (i = 1, 2, 3, 4, 5),
which is the RA equipment positioning repeatability;
h) The result shall meet the requirements of 4.3.2.
5.3.3 RA equipment system accuracy under navigation guidance
Test requirements for the RA equipment system accuracy under navigation
guidance:
Test requirements for translational clamping force in the working state of the
end instrument:
a) The RA equipment is equipped with a needle holder surgical instrument; a
No. 7 suture that meets the requirements of YY 0167 is clamped at the front
1/3 of the head of the needle holder;
b) Run the RA equipment; make the needle holder completely closed;
c) Apply the translational clamping force that is specified by the manufacturer
in the direction parallel to the principal axis of the needle holder pliers; the
suture must not slip off.
5.5.2.2 Driving torque
Test requirements for the driving torque in the working state of the end
instrument:
a) The RA equipment is equipped with a needle holder surgical instrument; the
midpoint of a suture straight round needle that meets the requirements of
YY/T 0043 is clamped at the front 1/3 of the head of the needle holder;
b) Run the RA equipment; make the suture straight round needle perpendicular
to the direction of the plier, and the needle holder completely closed;
c) Apply the torque that is specified by the manufacturer to the suture straight
round needle parallel to the direction of the plier; the suture needle shall not
be displaced.
Note: During the test, select the suture needle of corresponding
specifications according to the surgical indications of the RA
equipment.
5.6 Master-slave control time delay
Test requirements for the master-slave control time delay of the RA equipment:
a) Connect the moving parts of the linear motion generator to the operating
handle of the master equipment through a rigid connecting rod, so that it can
control the master equipment reference point to move along the measured
direction (Figure 9);
b) Under the master-slave control mapping ratio of 1:1, control the motion
generator to make the master equipment reference point move according to
the following requirements: the master equipment reference point
accelerates from the static state to 80% of the rated velocity (or the velocity
that is give in the standard) within 200 ms; after moving at a uniform velocity
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