YY/T 0191-2011 English PDF (YYT0191-2011)

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YY/T 0191-2011: Abdominal suction tube
YY/T 0191-2011
Abdominal suction tube
ICS 11.040.30
C36
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0191-1994
Abdominal suction tube
2011-12-31 released
2013-06-01 implementation
Issued by the State Food and Drug Administration
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0191-1994 "Abdominal Suction Tube".
The differences between this standard and YY/T 0191-1994 are as follows.
---Add applicable materials;
---Increase the firmness test method;
---Increase the patency test method;
--- Increase the corrosion resistance requirements and related test methods;
---Modified the electroplating requirements;
---Increase periodic inspection.
This standard was proposed and managed by the National Technical Committee for Standardization of Surgical Instruments (SAC/TC94).
Drafting organizations of this standard. Zhejiang Daji Medical Device Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this standard. Xia Jiming, Zhu Jianjun, Weng Binghao.
The previous versions of the standard replaced by this standard are as follows.
---WS2-225-1976, YY/T 0191-1994.
Abdominal suction tube
1 Scope
This standard specifies the product classification, requirements, test methods, inspection rules and signs, packaging, transportation, and storage of abdominal suction tubes.
This standard applies to the abdominal cavity 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 reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 1220 stainless steel rod
GB/T 1527 Copper and copper alloy drawn tubes
GB/T 2828.1 Sampling inspection procedure by attributes Part 1.Batch inspection sampling plan retrieved by acceptance quality limit (AQL)
GB/T 2829 Periodic Inspection Sampling Procedures and Tables by Attributes (Applicable to the Inspection of Process Stability)
GB/T 4423 Copper and copper alloy drawn rods
Review of GB/T 6463 Metal and Other Inorganic Covering Layer Thickness Measurement Methods
GB/T 10610 Geometrical Technical Specifications for Products (GPS) Surface Structure Profile Method. Rules and Methods for Evaluating Surface Structure
YY 0076-1992 Technical requirements for coating classification of metal parts
YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method
YY/T 0171-2008 Surgical instrument packaging, marking and instruction manual
YY/T 1052 Surgical instrument mark
3 Product Classification
3.1 Type and basic dimensions
3.1.1 The suction tube is divided into straight type, curved type and bent type according to the form.
3.1.2 The type and basic dimensions of the suction tube should meet the requirements of Figure 1 and Table 1.
3.2 Materials
The suction tube should be made of stainless steel material specified in GB/T 1220 or copper material specified in GB/T 1527 and GB/T 4423.
4 requirements
4.1 Dimensions
The outer diameter D1 of the suction pipe joint should meet the requirements of Table 1.
4.2 Patency
The suction pipeline should be unblocked, and the water absorption should not be less than.2000mL/min.
4.3 Robustness
The suction tube should be welded firmly, and the welding part should not be loose, cracked or broken.
4.4 Compatibility
The threaded connection of the suction tube should be well matched, and there should be no looseness or jamming.
4.5 Surface roughness
The value of the surface roughness Ra of the outer surface of the suction tube should not be greater than 0.4μm.
4.6 Corrosion resistance
4.6.1 The stainless steel suction tube should have good corrosion resistance, and its surface state after the test should not be lower than that specified in YY/T 0149-2006
5.4b level requirements.
4.6.2 The copper suction tube has been subjected to a saturated steam test at 134℃~138℃ for 20 minutes.
Traces of corrosion.
4.7 Electroplating
The electroplating of the copper suction tube should meet the requirements of D·L3Ni7/Cr0.3 specified in YY 0076-1992.
4.8 Appearance
4.8.1 The inner and outer tubes of the suction tube should be smooth and round, free of sharp edges, burrs and cracks.
4.8.2 There should be a suction hole at the top of the outer tube, and the arrangement of the surrounding suction holes should be even and tidy, and the number should be no less than 18.
4.8.3 There shall be no obvious blisters and accumulations at the welding place of the suction tube.
5 Test method
5.1 Dimensions
Measured with general or special measuring tools, the size of the suction tube should meet the requirements of 4.1.
5.2 Patency
The test is carried out under the condition of a negative pressure of 50kPa±2kPa, which shall meet the requirements of 4.2.
5.3 Robustness test
Fix the tube body of the suction tube, and apply a load of 50N on the axis of the suction tube and the joint perpendicular to the axis of the suction tube for 5s.
Observe the welded part, it should meet the requirements of 4.3.
5.4 Compatibility test
The manual disassembly of the suction tube by imitating the use action should meet the requirements of 4.4.
5.5 Surface roughness
Use the sample block comparison method or the profile method (GB/T 10610) for measurement, which should meet the requirements of 4.5.
The profile method is used for measurement during arbitration.
5.6 Corrosion resistance
5.6.1 Test according to the boiling water test method in YY/T 0149-2006, which should meet the requirements of 4.6.1.
5.6.2 Test with saturated steam at a temperature of 134°C to 138°C for 20 minutes and repeat the test 20 times (interval time is the sample
Cooled to room temperature shall prevail), which shall meet the requirements of 4.6.2.
5.7 Plating
The coating is measured according to the method specified in GB/T 6463 and should meet the requirements of 4.7.
5.8 Appearance
Observation with eyesight and feel should meet the requirements of 4.8.
6 Inspection rules
6.1 Acceptance
The suction tube is inspected by the quality department of the manufacturer, and can be submitted for acceptance only after it is qualified.
6.2 Inspection
Suction tubes should be submitted for inspection in batches, which are divided into batch-by-batch inspection (factory inspection) and periodic inspection (type inspection).
6.3 Batch inspection
6.3.1 The batch-by-batch inspection shall be carried out in accordance with the relevant regulations of GB/T 2828.1.
6.3.2 The batch-by-batch inspection adopts the one-time sampling plan of normal inspection, and its classification, inspection group, inspection item, inspection level and acceptance quality limit
(AQL) According to the provisions of Table 2.
Table 2 Batch inspection
6.4 Periodic inspection
6.4.1 Periodic inspection should be carried out in one of the following situations.
a) Before the new product is put into production (including the conversion of old products);
b) Products in continuous production are not less than once every two years;
c) Put into production after more than one year interval;
d) When there are major changes in design, process, and materials;
e) When the national quality supervision and inspection agency requests for supervision and random inspection.
6.4.2 The periodic inspection shall be carried out in accordance with the provisions of GB/T 2829.
6.4.3 A batch-by-batch inspection shall be carried out before the periodic inspection, and samples shall be taken from the batches that are qualified for the periodic inspection.
6.4.4 The periodic inspection adopts a sampling plan, its classification, inspection items, discrimination level, unqualified quality level (RQL) and sampling plan
According to the provisions of Table 3.
Table 3 Periodic inspection
7 signs
7.1 According to YY/T 1052, the suction tube should have the following signs.
a) The manufacturer's code or trademark;
b) Material mark;
c) Specifications.
7.2 The following contents should be included on the inspection certificate.
a) The name or trademark of the manufacturer;
b) Inspector code;
c) Date of inspection.
7.3 The packaging mark shall comply with the provisions of 4.1.1, 4.2.1 and 4.3 in YY/T 0171-2008.
8 Packaging, transportation and storage
8.1 Packaging
The suction tube should be packed in a box (multiple pieces should be packed separately), and there should be an inspection certificate in the box.
8.2 Transportation
The transportation requirements after packing are in accordance with the provisions of the order contract.
8.3 Storage
8.3.1 The packed suction tube should be stored in a room with a relative humidity of no more than 80%, no corrosive gas, and good ventilation.
8.3.2 After packaging, the suction tube should be guaranteed not to rust within two years under the condition of observing the storage rules.