YY/T 1057-2016_English: PDF (YY/T1057-2016)
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General specifications for medical foot switch
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| YY/T 1057-2016 | English | 130 |
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Genral specifications for medical foot switch
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YY/T 1057-2016
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| Standard ID | YY 1057-2016 (YY1057-2016) | | Description (Translated English) | General specifications for medical foot switch | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 5,586 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY 91057-1999 | | Quoted Standard | GB 4208-2008; GB 9706.1 | | Drafting Organization | Shanghai Institute of Medical Instrumentation | | Administrative Organization | National Standardization Technical Committee for Medical Electrical Equipment Standardization Subcommittee for Medical Electronic Equipment (SAC/TC 10/SC 5) | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terminology and definitions, requirements and test methods for medical foot switches. This standard applies to medical electrical equipment for the control circuit device foot switch. The scope of application of this standard does not include pneumatic and hydraulic foot switch. | | Standard ID | YY/T 1057-2016 (YY/T1057-2016) | | Description (Translated English) | Genral specifications for medical foot switch | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,629 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2018-01-01 | | Drafting Organization | Shanghai Medical Device Testing Institute | | Administrative Organization | National Medical Electrical Appliances Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC 10/SC 5) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the terms and definitions, requirements and test methods of medical foot switches. This standard applies to foot switches used as control circuit components for medical electrical equipment. The scope of application of this standard does not include pneumatic and hydraulic foot switches. |
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
......
YY/T 1057-2016 (Renamed from YY 1057-2016)
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 30
YY/T 1057-2016
Replacing YY 91057-1999
General specifications for medical foot switch
According to the National Medical Products Administration’s Medical Device
Industry Standard Announcement (No. 76 of 2022), this Standard will become a
recommended standard from September 7, 2022 and will no longer be mandatory.
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 4
5 Test methods... 6
General specifications for medical foot switch
1 Scope
This Standard specifies the terms and definitions, requirements and test methods for
medical foot switches.
This Standard applies to foot switches used as control circuit components for medical
electrical equipment. 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 application 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 Degree 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 purpose of this document, the following terms and definitions apply.
3.1
make-contact element (normally open)
A contact element that closes a circuit when the switch is activated.
3.2
break-contact element (normally closed)
A contact element that breaks a circuit when the switch is activated.
4 Requirements
4.1 Performance requirements
4.1.1 Starting force
The starting force of the foot switch shall be no less than 10 N and no more than 50 N.
4.1.2 Working resistance
For a foot switch that uses a make-contact element (normally open)/break-contact
element (normally closed), when the contact element is closed, the working resistance
shall not be greater than 500 mΩ.
4.1.3 Mechanical strength
4.1.3.1 The foot switch shall be able to withstand the weight of an adult in the normal
position.
4.1.3.2 The foot switch shall not be significantly damaged after an accidental fall.
4.1.3.3 After completing the mechanical strength test, the foot switch shall still meet
the requirements of 4.1.1 and keep the expected function intact.
4.1.3.4 After completing the mechanical strength test, the control setting of the foot
switch shall not change when it is in an abnormal use position.
Example. When a foot switch that uses a make-contact element (normally open) is placed upside
down relative to the normal use position, its contact element will not close.
4.1.4 Mechanical durability
4.1.4.1 The foot switch shall have sufficient mechanical durability.
4.1.4.2 After completing the mechanical durability test, the foot switch that uses a
make-contact element (normally open)/break-contact element (normally closed) shall
still meet the requirements of 4.1.2.
4.1.4.3 After completing the mechanical durability test, the foot switch shall still meet
the requirements of 4.1.1 and keep the expected function intact.
4.1.4.4 After completing the mechanical durability test, the control setting of the foot
switch shall not change when it is in an abnormal use position.
4.1.5 Bending test of connecting wires
After the test specified in 5.1.5, the port connector of the foot switch connecting wire
shall not be damaged and the expected function shall be intact.
4.1.6 Liquid ingress
After completing the tests of 5.1.3, 5.1.4 and 5.1.6, the foot switch shall be tested for
water ingress as specified in Clause 14 of GB 4208-2008 according to the liquid ingress
......
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