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YY/T 1686-2020

Chinese Standard: 'YY/T 1686-2020'
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BASIC DATA
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
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Medical electrical equipment employing robotic
technology - Classification
采用机器人技术的医用电气设备 分类
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JUNE 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 *Scope ... 4 
2 Terms and definitions ... 4 
3 * Classification ... 8 
Annex A (informative) Principle explanation ... 10 
Bibliography ... 12 
Medical electrical equipment employing robotic
technology - Classification
1 *Scope
This Standard specifies terms and definitions, classification of medical electrical
equipment employing robotic technology (hereinafter referred to as the
equipment) or medical electrical system (hereinafter referred to as the system).
NOTE: The chapters and articles with an asterisk (*) in this Standard have explanations
for relevant principles in Annex A.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1 * medical electrical equipment/system employing robotic technology
medical electrical equipment or medical electrical system that has two or more
programmable axes or programmable continuous axes, and a certain degree
of autonomy to imitate, assist or replace medical staff to perform specific tasks
NOTE 1: Each axis is controlled and coordinated by the control system.
NOTE 2: See IEC/TR 60601-4-1 for the degree of autonomy.
2.2 axis
a direction line that is used to define the device to move in a straight line or
rotation
NOTE: "Axis" is also used to mean "mechanical joints of equipment".
NOTE 2: Rewrite GB/T 12643-2013, definition 4.3.
2.3 medical electrical equipment
electrical equipment that has an application part or transmits or obtains energy
to the patient or detects these transmitted or obtains energy; such electrical
equipment:
a) has no more than one connection to a specified power supply network,
problem with human body function or structure, such as severe deviation or loss
of function or structure
2.9 * movement function
including one or more sensory, neuromusculoskeletal, or sports-related human
functions; these human functions implement motion control
NOTE: "Sensory", "neuromusculoskeletal" and "sports-related" come from the World
Health Organization (WHO) classification of body functions.
2.10 body functions
physiological functions of the human system (including pathological functions)
[ISO 9999:2016, definition 2.4]
2.11 body structures
anatomical parts of the human body such as organs, limbs and their
components
[ISO 9999:2016, definition 2.5]
2.12 * placement
positioning, holding or fixing of surgical instruments intended for use in the
equipment or system
2.13 manipulation
usually grasp and/or move objects with multiple degrees of freedom, such as
tissues or surgical instruments
NOTE: Rewrite GB/T 12643-2013, definition 2.1.
2.14 master-slave control
a control method that the equipment or system slave unit (slave) reproduces
the master unit (master) movement
NOTE: Rewrite GB/T 12643-2013, definition 5.3.4.
2.15 cooperative control
a control method that the equipment or system cooperates with the operator to
complete the operation in its work space
2.16 hand-held
2.24 limbs
the parts of the human body excluding the head, neck, and trunk
2.25 * powered exoskeleton
medical electrical equipment that consists of externally powered electric
orthotics; it is placed on the patient's paralyzed or weakened limb to provide the
patient with mobility
2.26 orthosis
external use device for changing the structure and functional characteristics of
neuromusculoskeletal system
[GB/T 14191.1-2009, definition 2.1.2]
2.27 home healthcare environment
patient's residence or other location where the patient is located, excluding
medical institutions where a trained operator is present as long as the patient
is present
Examples: Cars, buses, trains, ships or airplanes, as well as wheelchairs or
outdoor walking environments.
NOTE 1: A medical institution refers to an institution that has been registered and obtained
a "Medical Institution Practicing License" in accordance with the "Medical Institution
Management Regulations" and the "Implementation Rules of the Medical Institution
Management Regulations".
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 According to expected purpose
3.1.1 Used to assist surgery
3.1.1.1 According to clinical use, it is classified into used to place surgical
instruments and manipulate surgical instruments.
3.1.1.2 According to control mode, it is classified into master-slave control and
cooperative control.
Annex A
(informative)
Principle explanation
A.1 Explanation of standard name
The standardized objects to which this Standard applies are usually called
robots for medical use and medical robots. However, there is no universally
recognized definition of "robots for medical use" and "medical robots", and there
are several problems:
- Subject dislocation. According to international standards, such products are
medical electrical equipment or system that use robotics technology, not
robots.
- Unclear scope. At present, dispensing robots and medical service robots
have appeared on the market. These products are completely inconsistent
with the administrative departments, product risk points and
implementation standards of medical electrical equipment, and it is difficult
to confuse them.
- According to the "Rules for the Naming of Common Names of Medical
Devices", medical devices of the same type with the same or similar
expected purpose and common technology shall use the same common
name. But the intended purpose of medical electrical equipment or system
using robotics is very broad, including usage for surgery assistance,
rehabilitation, compensation. It is not scientific to use a generic name to
cover all expected purposes, nor does it meet the requirements of medical
device regulations and registration review requirements.
Therefore, inspired by the terms of US Food and Drug Administration (FDA)
and in......
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