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YY 1057-2016: PDF in English

YY 1057-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 30
Replacing YY 91057-1999
General specifications for medical foot switch
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration of China
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 5 
4 Requirements ... 5 
5 Test methods ... 7 
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY 91057-1999 "General specifications for medical foot
switch. The main technical changes are as follows.
- modified the application scope of the standard;
- modified the requirements for mechanical strength, fluid protection and
connecting wires;
- added "4.2 Safety requirements";
- deleted "2.1 Manufacture" of YY 91057-1999;
- deleted "2.9 Stationarity" of YY 91057-1999;
- deleted "2.10 Electrical safety" of YY 91057-1999;
- deleted "2.11 Mechanical and climatic environment test" of YY 91057-
1999;
- deleted "2.12 Shell paint" of YY 91057-1999;
- deleted "2.13 Requirements for repair or replacement" of YY 91057-1999;
- deleted "4 Inspection rules" of YY 91057-1999;
- deleted "5 Requirements for marks, packaging, transport, storage" of YY
91057-1999.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration of China.
This Standard shall be under the jurisdiction of Subcommittee on Medical
Electronic Equipment of National Technical Committee on Medical Appliance of
Standardization Administration of China (SAC/TC 10/SC 5).
The drafting organizations of this Standard. Shanghai Medical Device Testing
Institute.
Main drafters of this Standard. He Jun, Hu Sheng.
Version of standard substituted by this Standard is.
General specifications for medical foot switch
1 Scope
This Standard specifies the terms and definitions, requirements and test
methods for medical foot switch.
This Standard is applicable to foot switch for medical electrical equipment as
control circuit device. The scope of application of this Standard does not include
pneumatic and hydraulic foot switches.
NOTE Foot switches that are not within the scope of this Standard can still refer to the relevant
provisions of this Standard.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 4208-2008, Degrees of Protection Provided By Enclosure (IP Code)
GB 9706.1, Medical electrical equipment - Part 1.General requirements for
safety
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 make-contact element (normally open)
a contact element of closing a circuit when the switch is activated
3.2 break-contact element (normally closed)
a contact element of disconnecting a circuit when the switch is activated
4 Requirements
4.1 Performance requirements
possible abnormal positions. The control setting of the foot switch shall not be
changed accidentally.
5.1.4 Mechanical durability
5.1.4.1 Operate the foot switch to perform 30,000 no-load (no operating
current) operation cycle. The movable part of the foot switch shall reach the
maximum operating position in both directions. The foot switch shall be free
from damage after the test and the function is expected to be intact.
5.1.4.2 The foot switch that uses make-contact element (normally open)/
break-contact element (normally closed), after performing the test specified in
5.1.4.1, when the contact element of the foot switch is under closed state, shall
use the Kelvin four-wire method to measure the working resistance of the foot
switch at the far end of the foot switch cable.
5.1.4.3 After the test specified in 5.1.4.1 is carried out, the starting force of the
foot switch shall be measured according to the test method of 5.1.1, and the
requirements of 4.1.1 shall be met. Simulate the expected function of the foot
switch to verify its integrity.
5.1.4.4 After the test specified in 5.1.4.1, the foot switch is turned over and
placed on the support surface in various possible abnormal positions. The
control setting of the foot switch shall not be accidentally changed.
5.1.5 Wire bending test for connection
First, let the axis at the connection wire port be in the vertical direction, and
hang an object with a mass of 3kg on the connecting wire 1m from the port.
Tilt the foot switch to bend the connecting wire by 90° and keep it at this position
for 1min.
Subsequently, the foot switch is tilted in the opposite direction of the vertical
direction, so that the connecting wire is bent by 90°, and held at this position for
1min. After the test, the connecting wires shall meet the requirements of 4.1.5.
5.1.6 Liquid injection
The foot switch shall be tested for water ingress as specified in Clause 14 of
GB 4208-2008 in accordance with the liquid inlet protection (IPX) class
specified by the manufacturer. After the test, check if the foot switch still
achieves the desired function.
5.2 Safety requirements
The compliance with 4.2 requirements shall be checked by the test in GB
9706.1 and the relevant tests in the professional standards applicable to the
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.