YY/T 0842-2011 English PDF (YYT0842-2011)

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YY/T 0842-2011: Medical endoscopes - Endoscope accessories - Sheaths
YY/T 0842-2011
YY
ICS 11.040.99
C 40
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
Medical endoscopes –
Endoscope accessories - Sheaths
(ISO 8600-1.2005, Optics and photonics - Medical endoscopes and
endotherapy devices - Part 1. General requirements; ISO 8600-4.1997, Optics
and optical instruments - Medical endoscopes and certain accessories - Part
4. Determination of maximum width of insertion portion, NEQ)
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 01, 2013
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... 5 
5 Test methods ... 8 
6 Inspection rules ... 10 
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
The Standard is established under the title of “Medical endoscopes - Endoscope
accessories”.
This Standard not-equivalently adopts the international standards ISO 8600-1.2005
“Optics and photonics - Medical endoscopes and endotherapy devices - Part 1.
General requirements” and ISO 8600-4.1997 “Optics and optical instruments - Medical
endoscopes and certain accessories - Part 4. Determination of maximum width of
insertion portion”.
Please note that some of the content of this document may involve patents. The issuing
agency of this document does not undertake the responsibility for the identification of
these patents.
This Standard was proposed by the China Food and Drug Administration.
The Standard shall be under the jurisdiction of the National Standardization Technical
Committee on Medical Optical Instruments (SAC/TC 103/SC 1).
Drafting organizations of this Standard. Hangzhou Quality Supervision and Inspection
Center on Medical Device under State Food and Drug Administration, Zhejiang
Institute for the Control of Medical Device.
Main drafters of this Standard. Yan Qinglai, Jia Xiaohang, Zhang Xinyuan.
Medical endoscopes –
Endoscope accessories – Sheaths
1 Scope
This Standard specifies the requirements and test methods of sheaths.
This Standard applies to sheaths for the insertion of medical endoscopes.
2 Normative references
The following documents are essential for the application of this document. For all
dated reference documents, only the dated versions are applicable to this document.
For all undated reference documents, the latest versions (including all modifications)
are applicable to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and
testing within a risk management process (ISO 10993-1.2009, IDT)
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion
resistance (ISO 13402.1995, MOD)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Endoscope accessory
Optional accessories that are necessary and/or suitable to be used with endoscopes,
to achieve the intended use of endoscopes, or to provide convenience for the intended
use of endoscopes, or to improve the intended use of endoscopes, or to increase the
additional use of endoscopes.
3.2
Sheath
External inserting pipes for guiding endoscopes or endotherapy devices.
3.3
Main channel
A part of sheaths. Endoscopes or endotherapy devices are required to be inserted
through this part.
3.4
Minimum main channel width
Minimum internal width of the channel of endoscopes or endotherapy devices.
3.5
Insertion portion
A part of sheaths, which can be inserted into natural channels or surgical incisions of
human bodies.
3.5.1
Working length
Maximum length of sheath's insertion portion.
4 Requirements
4.1 Materials
4.1.1 Chemical composition of metal materials
Manufacturers of the metal materials that directly or indirectly contact with patients
shall explicitly indicate in any possible form, wherein the metal materials shall be
marked with grades and/or code as well as the requirements for materials' chemical
composition. The chemical composition of metal materials shall be verified by tests.
4.1.2 Biological compatibility
Materials that directly or indirectly contact with patients shall be conducted with
biological safety evaluation in accordance with the principles and requirements in GB/T
Sheaths and endoscopes or scope mounts or obturators shall meet the following
requirements after mounting.
a) the positioning shall be reliable and has no loosening after full insertion;
b) except for no sealing requirement claimed by the manufacturer, the sealing after
full insertion shall be in a good condition. The water seeped shall not exceed
more than 5 drops within 1 min when performing water permeability test.
4.4 Connection
Every connecting portion involving sheaths shall be connected by tight mounting
method, the mounting area shall be no visible cracks; if it is connected by welding, the
welding seam shall be no unevenness, loose weld, bead weld or apparent pitting; if it
is connected by gluing, the gluing area shall be no effusion or apparent heaping glue,
other parts shall be no flow trance of glue.
4.5 Outer surface quality of insertion portion
Except for special purpose, there shall be nothing that may cause injury on the
insertion portion.
4.6 Water-passing and/or air-passing functions
4.6.1 Water-passing and/or air-passing ducts
If the sheath has water-passing and/or air-passing functions, there shall be no
impurities in water-passing and/or air-passing ducts, and water-passing and/or air-
passing processes shall be smooth.
4.6.2 Water-passing and/or air-passing connectors
If the sheath has water-passing and/or air-passing functions, the manufacturer shall
provide the specification of water-passing and/or air-passing connectors. Water-
passing and/or air-passing connectors of sheath shall meet the requirements of this
specification or relevant standards applicable for this specification.
4.7 Tolerance (applicable for non-disposable products)
After the following tolerance tests, the sheath shall still be able to meet the
requirements of 4.3.
a) High-pressure and high-temperature resistance
Sheaths with high-pressure and high-temperature resistance shall be able to
5.6 Water-passing and/or air-passing functions
5.6.1 Water-passing and/or air-passing ducts
VERIFY by visual observation and water-passing and air-passing operations.
5.6.2 Water-passing and/or air-passing connectors
MEASURE according to the method specified in the relevant standards applicable for
connector specification.
5.7 Tolerance test
5.7.1 High-temperature and high-pressure resistance test
After performing 20 times of high-temperature and high-pressure resistance test (the
test conditions are in accordance with the specification in manufacturer's instruction
manual), the result shall still meet the requirements of 4.3.
5.7.2 Corrosion resistance test
The portion uses stainless steel material shall be tested according to the boiling water
test method in YY/T 0149-2006, the result shall meet the requirements of 4.7 b). Other
materials shall be processed according to the sterilization method specified by the
manufacturer in the instruction manual, there shall be no corrosion, and the result shall
still meet the requirements of 4.3.
6 Inspection rules
Inspection rules are made by the manufacturer according to product features.