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YY/T 1686-2020

Chinese Standard: 'YY/T 1686-2020'
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YY/T 1686-2020English199 Add to Cart Days<=3 Medical electrical equipment employing robotic technology--Classification Valid YY/T 1686-2020
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Standard ID YYT1686-2020 (YYT1686-2020)
Description (Translated English) Medical electrical equipment employing robotic technology--Classification
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 10,171
Date of Issue 2020-02-21
Date of Implementation 2021-06-01
Drafting Organization China Food and Drug Administration, China Medical Device Technology Evaluation Center, Shanghai Medical Device Testing Institute, Tianjin University, Shanghai Jiaotong University, Suzhou University, Guangdong Jiamei Certification Co., Ltd. Shanghai Branch, People's Liberation Army General hospital
Administrative Organization National Medical Appliance Standardization Technical Committee (SAC / TC 10)
Regulation (derived from) Announcement No. 20 of 2020 by the State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1686-2020
Medical electrical equipment employing robotic technology--Classification
ICS 11.040
People's Republic of China Pharmaceutical Industry Standard
Classification of medical electrical equipment using robotics
2020-02-21 released
2021-06-01 implementation
Issued by the State Drug Administration
Table of contents
Foreword Ⅰ
1 * range 1
2 Terms and definitions 1
3 * Category 4
Appendix A (informative appendix) Principle explanation 5
Reference 7
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee (SAC/TC10).
Drafting organizations of this standard. China Institute for Food and Drug Control, Medical Device Technical Evaluation Center of the State Drug Administration, Shanghai
Medical Device Testing Institute, Tianjin University, Shanghai Jiaotong University, Soochow University, Guangdong Jiahuamei Certification Co., Ltd. Shanghai Branch, Chinese People
PLA General Hospital.
The main drafters of this standard. Zheng Jia, Yu Xinhua, Peng Liang, He Jun, He Kunlun, Chen Min, Kuang Chao, Xing Yuan, Xu Kai, Bai Mengjie, Kuang Shaolong,
Zhou Juan.
Classification of medical electrical equipment using robotics
1 Scope
This standard specifies the requirements for medical electrical equipment (hereinafter referred to as equipment) or medical electrical systems (hereinafter referred to as systems) using robotics technology.
Terms and definitions, classification.
Note. The chapters and articles with an asterisk (*) in this standard have relevant principles in Appendix A.
2 Terms and definitions
The following terms and definitions apply to this document.
*Medical electrical equipment/systems using robotics
With two or more programmable axes or programmable continuous axes, and a certain degree of autonomy, imitate, assist or replace medical staff
Medical electrical equipment or medical electrical systems that perform specific tasks.
Note 1.Each axis is controlled and coordinated by the control system.
Note 2.Refer to IEC /T R60601-4-1 for the degree of autonomy.
It is used to define the direction line of the device moving in a straight line or in a rotating manner.
Note 1."Axis" is also used to mean "mechanical joints of equipment".
Note 2.Rewrite GB/T 12643-2013, definition 4.3.
Medical electrical equipment
Electrical equipment that has an application part or transmits or obtains energy to the patient or detects these transmitted or obtained energy. Such electrical
a) There is no more than one connection to a specified power supply network, and
b) Its manufacturer intends to use it for.
1) Diagnosis, treatment or monitoring of patients, or
2) Eliminate or reduce disease, injury or disability.
Medical electrical system
A combination of several devices that are functionally connected or connected to each other using multiple sockets under the manufacturer's regulations, and at least one of the combinations
One is medical electrical equipment.
Procedures include tissue incision, excision, manipulation or suture, and usually require local or general anesthesia or deep sedation to control pain.
*Rehabilitation is a treatment to improve patients' related sports function impairments.
Note 1.For example, the relearning of upper or lower limb movement control, the recovery of muscle strength and endurance.
Note 2.Rehabilitation can be carried out when the patient is injured due to accidents, diseases or congenital symptoms (such as cerebral palsy), and can also be used to slow down neurodegeneration.
Expected loss of body function caused by chronic diseases (such as Parkinson's disease, multiple sclerosis, etc.).
Note 3.This definition is different from the definition of the World Health Organization (WHO), and only covers the impairment of the patient's motor function, in order to be consistent with the standard scope.
*Compensation relieves patient injury by supporting human body structure or human body function, or replacing human body function.
Note. Compensation can be provided by external power orthotics. Compensation does not include the improvement of related motor function impairment as defined in rehabilitation.
* Problems that damage the function or structure of the human body, such as severe deviation or loss of function or structure.
*Motion functions include one or more sensory, neuromusculoskeletal, or sports-related human functions that realize motion control.
Note. "Sense", "Neuromusculoskeletal" and "exercise-related" come from the World Health Organization (WHO) classification of body functions.
Human body function
The physiological functions of the human system (including pathological functions).
Anatomical parts of the human body such as organs, limbs and their components.
*Placement is expected to be used for the positioning, holding or fixing of surgical instruments used by the device or system.
Operations usually grasp and/or move objects, such as tissues or surgical instruments, with multiple degrees of freedom.
Note. Rewrite GB/T 12643-2013, definition 2.1.
Master-slave control
Equipment or system slave unit (slave) reproduces the control method of the master unit (master) movement.
Note. Rewrite GB/T 12643-2013, definition 5.3.4.
Cooperative control equipment or system in its work space to cooperate with the operator to complete the operation of the control method.
After the handheld device is installed and placed into use, it is expected to be held by the hand.
Note. The equipment can be accessories or equipment parts.
Wearable is a transferable device worn by the patient or attached to the patient's clothing during operation.
The upper limb is the part of the human body that consists of the hands, forearms, upper arms, scapular area and joints between them.
Lower limbs
The part of the human body that consists of feet, calves, thighs, pelvic area and joints between them.
The part of the human body beyond the wrist of the upper limb.
[GB/T 14191.1-2009, definition 2.2.11]
* Active training activetraining
The patient's limbs actively drive the equipment or system for rehabilitation training, and the equipment can output damping force and exert resistance to the movement of the limbs.
The equipment or system provides certain auxiliary force to the limbs to drive the limbs to perform rehabilitation training.
*Passive training of patients' limbs is driven by equipment or system for rehabilitation training.
The head, neck, and trunk are removed from the human body.
*The power exoskeleton is a medical electrical device composed of an externally powered electric orthosis, which is placed on the patient's paralyzed or weakened limb to provide the patient with mobility
Orthosis is a device used outside the body to change the structure and functional characteristics of the neuromusculoskeletal system.
[GB/T 14191.1-2009, definition 2.1.2]
In the home care environment, the patient’s residence or other location where the patient is located does not include medical institutions where a trained operator is present as long as the patient is present.
Examples. in cars, buses, trains, ships or airplanes, and in wheelchairs or outdoor walking environments.
Note 1.A medical institution refers to a medical institution that has been registered in accordance with the Regulations on the Management of Medical Institutions and the Implementation Rules of the Regulations on the Management of Medical Institutions.
Note 2.Other places where patients appear include outdoor environments where they walk or travel by car.
Note 3.Rewrite IEC 60601-1-11.2015, definition 3.1.
3 *Classification
3.1 As expected
3.1.1 For auxiliary surgery According to clinical use, it is divided into being used to place surgical instruments and manipulate surgical instruments. According to the control mode, it is divided into master-slave control and cooperative control. According to the mode of use, it is divided into handheld and non-handheld.
3.1.2 For rehabilitation According to the mode of use, it is divided into wearable and non-wearable. According to the part of action, it is divided into upper limbs (excluding hands), lower limbs, hands, and other parts. According to the training mode, it is divided into active training, assisted training and passive training.
3.1.3 For compensation
Divided into power exoskeleton, other electric orthotics, etc.
3.2 By place of use
Divided into home care environment and medical institutions.
3.3 By applicable people
Divided into adults, children, and newborns.
Appendix A
(Informative appendix)
Principle explanation
A.1 Description of the standard name
The standardized objects to which this standard applies are usually called medical robots, medical robots, etc. But "medical robots" and "medical robots"
There is no universally accepted definition, and there are several problems.
---The main body is misplaced. According to international standards, such products are medical electrical equipment or systems that use robotics technology, not robots.
---The scope is unclear. At present, there are dispensing robots and medical service robots on the market. Administrative of these products and medical electrical equipment
Competent departments, product risk points, and implemented standards are completely inconsistent, and it is difficult to confuse them.
---According to the "Medical Device Naming Rules", medical devices of the same type with the same or similar expected purpose and common technology
The equipment should use the same common name. The expected purpose of medical electrical equipment or systems using robotics is very wide.
Including for auxiliary surgery, rehabilitation, compensation, etc., it is neither scientific nor consistent to use a common name to cover all expected purposes
Meet the requirements of medical device regulations and registration review requirements.
Therefore, inspired by the terms related to the U.S. Drug Administration (FDA) and international standards, the standardization objects to which this standard applies
The name is determined to be medical electrical equipment or systems using robotics technology. The name is not a generic name for this type of product, but is clear
The main body of this type of product also clarifies the technical characteristics of this type of product that distinguish it from other medical electrical equipment or systems. With different expectations
The purpose of this type of product, according to the requirements of the naming rules, the specific general name is determined.
A.2 Principle explanation of special chapters and clauses
This standard focuses on scientific classification of medical electrical equipment or systems that use robotics, so the terms and definitions given by the standard
These are terms involved in the classification (see Chapter 1).
At present, the definition of robots in domestic and foreign standards is not unified. The definition given in this standard (see Chapter 2) is based on
Or related definitions in national or international standards under development, combined with existing product characteristics. The corresponding relationship is shown in Table A.1.
The classification of this standard (see Chapter 3) is based on existing knowledge and representative product technical characteristics and risk points, giving a multi-dimensional
Classification method. With the development of industry and technology, related products are not limited to the classification given in this standard. This classification can help
Related parties such as testing, manufacturers, etc. understand the relevant standards that need to be considered in the design and use of different categories of equipment and the risks that need to be controlled.
It helps related parties to more scientifically determine the generic name of the product, and at the same time provides ideas for the construction of the standard system for this type of product.
[1] GB 11291.1-2011 Safety requirements for robots used in industrial environments Part 1.Robots
[2] GB/T 12643-2013 Robot and Robot Equipment Vocabulary
[3] GB/T 14191.1-2009 Terminology of prosthetics and orthotics Part 1.External limb prostheses and external orthoses
Basic terminology
Related standard:   YY/T 1695-2020  YY/T 1695-2020
Related PDF sample:   YY/T 1681-2019  YY/T 1630-2018
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