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YY/T 0191-2011 PDF in English


YY/T 0191-2011 (YY/T0191-2011, YYT 0191-2011, YYT0191-2011)
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Standards related to: YY/T 0191-2011

YY/T 0191-2011: PDF in English (YYT 0191-2011)

YY/T 0191-2011
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 36
Replacing YY/T 0191-1994
Abdominal suction tube
腹腔吸引管
ISSUED ON: DECEMBER 31, 2011
IMPLEMENTED ON: JUNE 01, 2013
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Product classification ... 5 
4 Requirements ... 6 
5 Test methods ... 7 
6 Inspection rules ... 8 
7 Marking ... 9 
8 Packaging, transportation, storage ... 10 
Abdominal suction tube
1 Scope
This Standard specifies the product classification, requirements, test methods,
inspection rules and marking, packaging, transportation, and storage of
abdominal suction tubes.
This Standard applies to the abdominal suction tube (hereinafter referred to as
the suction tube). The product is installed on the suction device for liquid suction
during abdominal surgery.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB/T 1220, Stainless steel bars
GB/T 1527, Drawn tube of copper and copper alloys
GB/T 2828.1, Sampling procedures for inspection by attributes - Part 1:
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection
GB/T 2829, Sampling procedures and tables for periodic inspection by
attributes (apply to inspection of process stability)
GB/T 4423, Copper and copper alloy cold-drawn rod and bar
GB/T 6463, Metallic and other inorganic coatings - Review of methods of
measurement of thickness
GB/T 10610, Geometrical product specifications (GPS) - Surface texture:
Profile method - Rules and procedures for the assessment of surface texture
YY 0076-1992, Coating classifications for metal product - Technical
conditions
YY/T 0149-2006, Medical instruments of stainless steel - Test methods of
corrosion resistance
YY/T 0171-2008, Surgical instruments - Packaging, Marking and Instructions
3.2 Materials
The suction tube shall be made of stainless-steel material that is specified in
GB/T 1220 or copper materials that are specified in GB/T 1527 and GB/T 4423.
4 Requirements
4.1 Dimensions
The outer diameter dimension D1 of the suction tube joint shall meet the
requirements of Table 1.
4.2 Patency
The suction tube shall be smooth; the water absorption shall not be less than 2
000 mL/min.
4.3 Soundness
The suction tube shall be welded firmly; the welding part shall not be loose,
cracked or broken.
4.4 Compatibility
The threaded connection of the suction tube shall be well matched, and there
shall be no looseness or jamming.
4.5 surface roughness
The value of the surface roughness Ra of the outer surface of the suction tube
shall not be greater than 0.4 μm.
4.6 Corrosion resistance
4.6.1 The stainless-steel suction tube shall have good corrosion resistance; its
surface state after the test shall not be lower than the requirements for grade b
in 5.4 of YY/T 0149-2006.
4.6.2 The copper suction tube shall not have damage or corrosion marks which
cannot be removed by wiping after a saturated steam test at 134 °C ~ 138 °C
for 20 minutes.
4.7 Electroplating
The electroplating of the copper suction tube shall meet the requirement for
D·L3Ni7/Cr0.3 that is specified in YY 0076-1992.
4.8 Appearance
4.8.1 The inner and outer tubes of the suction tube shall be smooth and round,
free of sharp edges, burrs and cracks.
4.8.2 There shall be a suction hole at the top of the outer tube; the arrangement
of the surrounding suction holes shall be even and tidy, and the number shall
be no less than 18.
4.8.3 There shall be no obvious blisters and accumulations at the weld of the
suction tube.
5 Test methods
5.1 Dimensions
Use a general or special measuring tool to measure; the dimensions of the
suction tube shall meet the requirements of 4.1.
5.2 Patency
Carry out the test under the condition of a negative pressure of 50 kPa± 2 kPa,
which shall meet the requirements of 4.2.
5.3 Soundness test
Fix the tube body of the suction tube; load a load of 50 N on the axial and
perpendicular joints of the suction tube, respectively, for 5 s; observe the
welding position, which shall meet the requirements of 4.3.
5.4 Compatibility test
Imitate the use action to manually disassemble the suction tube, which shall
meet the requirements of 4.4.
5.5 Surface roughness
Use the sample piece comparison method or the profile method (GB/T 10610)
for measurement, which shall meet the requirements of 4.5.
Use the profile method for measurement during arbitration.
5.6 Corrosion resistance
5.6.1 Perform the test according to the boiling water test method in YY/T 0149-
2006, which shall meet the requirements of 4.6.1.
5.6.2 Use the saturated steam at a temperature of 134 °C ~ 138 °C to perform
the test for 20 minutes; repeat the test 20 times (the interval is based on the
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.