YY/T 1686-2020 Medical electrical equipment employing robotic technology - Classification
1 *Scope
This standard specifies the terms, definitions, and classification of medical electrical equipment (hereinafter referred to as equipment) or medical electrical systems (hereinafter referred to as systems) employing robotic technology.
Note: The clauses and subclauses with asterisk (*) in this standard are described in the 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 with two or more programmable axes or programmable continuous axes, and a degree of autonomy to simulate, assist or replace medical workers in carrying out 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
direction line used to define the movement of equipment in a straight or rotational manner
Note 1: "Axis” is also used to represent "mechanical joint of equipment".
Note 2: It is modified from GB/T 12643-2013, Definition 4.3.
2.3
medical electrical equipment
electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:
a) provided with no more than one connection to a particular supply mains; and
b) intended by its manufacturer to be used:
Foreword i
1 *Scope
2 Terms and definitions
3 *Classification
Annex A (Informative) Rationale
Bibliography
