This standard specifies the technical requirements, test methods, inspection rules and marking, packaging, transportation, storage and other requirements for gill-penetrating hemostatic forceps. This standard applies to gill-penetrating hemostatic forceps. GB 2766-1995 General Technical Conditions for Gill-penetrating Hemostatic Forceps GB2766-1995 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
General Specifications for Gill-penetrating Hemostatic Forceps
Haemostatic forceps with box jointGeneral specifications
GB 2766---1995
Replaces GB2766-88
This standard adopts the international standard IS(）7151--1988 "General requirements and test methods for surgical instruments, non-cutting articulated instruments". 1 Subject content and scope of applicationwww.bzxz.net
This standard specifies the technical requirements, test methods, inspection rules and marking, packaging, transportation, storage and other requirements for gill-penetrating hemostatic forceps products (hereinafter referred to as forceps).
This standard applies to gill-penetrating hemostatic forceps products. 2 Reference standards
GB230--91Method for testing Rockwell hardness of metalsGB1220-92Stainless steel bars
GB 2828-87
GB 8938-88
Batch inspection counting sampling procedures and sampling tables (applicable to inspection of continuous batches)Typed paper
GB/T10160-1995Determination of locking force and disengagement force of medical forcepsGB 12655--90
Cigarette paper
ZB C30 001-84
Surgical instrument marking
WS2/Z--22-75 Determination of the swing of the head end of medical forceps--General provisionsWS2/Z--23-75 Determination of the swing of the head end of medical forcepsDetermination conditions (-)3 Technical requirements
3.1 The type and basic dimensions of the forceps should be specified in the product standard. The width (6,) and thickness (8,) of the head end should be checked item by item during acceptance.
3.2 The forceps should be made of 2Cr13Mo and 2Cr13 materials specified in GB1220, and the gill shaft of the forceps should be made of 2Cr13 and 1Cr13 materials specified in GB1220.
3.3 The pliers, except for the gill axis, should be heat treated, with a hardness of HRC40~48, and the difference in hardness between the two pieces should not be greater than HRC4.3.4 The pliers should be symmetrical, and there should be no sharp edges, burrs or cracks on the surface. The sharp edges of the gill angles must be removed. 3.5 The grinding teeth should be clear, and there should be no missing teeth, rotten teeth or burrs. 3.6 The pliers should have good elasticity and firmness. 3.7 When the locking teeth of the pliers are fully locked, the lip teeth should match; the hook and groove of the lip hook of the hooked pliers should match, and there should be no jamming or deflection. 3.8 The pliers should have good locking performance. When the locking teeth are fully locked, the locking force and disengagement force should meet the requirements of the product standards. 3.9 The opening and closing of the pliers should be easy and flexible, and the swing amount should meet the requirements of the product standards. 3.10 The pliers should have good corrosion resistance. 3.11 The surface of the pliers can be made shiny or matte, and the value of its surface roughness R. should not be greater than that specified in Table 1. Approved by the State Administration of Technical Supervision on June 2, 1995 360
She installed film
Implementation on December 1, 1995
Test method
GB 2766-1995
Shiny
4.1 Dimension inspection: Use general measuring tools or special measuring tools to measure the surface of the pliers
Non-shiny
4.2 Hardness inspection: According to the provisions of GB230, measure three points on the upper end plane of the rod or the plane near the gills of the head, and take the arithmetic average of the three points.
4.3 Appearance inspection: Visual observation.
4.4 Elastic firmness test: Use a brass rod with a diameter equal to 5% of the length from the tip of the pliers to the center of the gill axis (1), place it on the front end of the head, completely lock it, and then relax it. Repeat 2 to 3 times. The pliers should not be deformed or broken. 4.5 Lip head teeth fit test: Visually observe that the lip head teeth should fit together. Then put the material specified in GB8938 or GB12655 in the lip head teeth, completely lock it, and then relax it. (For pliers without hooks, except for the 5 teeth at the back root; for pliers with hooks, except for the two teeth below the lip head hook and the 5 teeth at the back root). There should be obvious and clear marks on the paper.
4.6 Locking force test: According to the provisions of GB/T10160, measure three times and take the arithmetic mean of the readings. Disengagement force test: According to the provisions of GB/T10160, measure three times and take the arithmetic mean of the readings. 4.7
4.8 Inspection of head end swing: Test as specified in WS2/Z-22 and WS2/Z--23. 4.9 Inspection of corrosion resistance
4.9.1 Wash the pliers with soap and warm water, then rinse thoroughly in distilled water and dry. 4.9.2 Boil the pliers in a beaker or rust-proof container filled with distilled water for 30 minutes, then cool with the distilled water for at least 1 hour. 4.9.3 Remove the pliers from the distilled water and expose them to air for 2 hours. 4.9.4 The pliers that have undergone the above tests must be wiped clean with a dry cloth and checked for visible signs of corrosion. They should be rubbed vigorously by hand with a cloth, and spots that cannot be wiped off should be considered signs of corrosion.
4.10 Surface roughness shall be measured by sample comparison method or electrical measurement method. The electrical measurement method shall be used for quality arbitration. 5 Inspection rules
5.1 The pliers shall be inspected by the technical inspection department of the manufacturer and can only be submitted to the ordering party for acceptance after they are qualified. 5.2 Pliers must be submitted for inspection in batches.
5.3 Batch inspection
5.3.1 Batch inspection shall comply with the provisions of GB2828. 5.3.2 The batch inspection of pliers adopts one-time sampling. The strictness of the sampling plan starts from the normal inspection sampling plan. The classification of unqualified products (in terms of unqualified items per month), inspection items, inspection level and qualified quality level shall be in accordance with the provisions of Table 2. Table 2
Unqualified product classification
Unqualified product classification group
Inspection items
Inspection level
Qualified quality level
3.3 3.6
Note: The materials are controlled by the factory during the process of processing. E
Disengagement force
Locking force
6 Marking, packaging, transportation and storage
GB 27661995
6.1 Each pair of pliers shall have the following markings in accordance with the provisions of ZBC30001: a.
Manufacturer code or trademark;
Year of production (the last two characters);
2Cr13 stainless steel pliers shall have the material mark \Cr”; 2Cr13Mo stainless steel pliers shall have the material mark \Mo”. 6.2 After being treated with rust prevention, each pair of pliers shall be packed in a neutral plastic bag. The bag shall have a certificate of inspection and shall be sealed. The certificate of inspection shall have the following markings:
Manufacturer name or trademark;
Inspector code.
6.3 Every 2, 5 or 10 pliers of the same type and specification are packed in a box, and the box should have the following marks: a.
Manufacturer name and trademark;
Product name;
Specification;
Quantity;
Product standard number;
Address of the factory.
6.4 The box should be sealed with the following marks: a.
Sealing date:
Packer code.
6.5 Special needs can be packaged on demand.
6.6Packaging and transportation requirements shall be in accordance with the order contract. 6.7Packaged pliers should be stored in a room with a relative humidity not exceeding 80%, no corrosive gas and good ventilation. Additional remarks:
This standard is proposed by the National Technical Committee for Standardization of Surgical Instruments. This standard is under the jurisdiction of the National Medical Device Quality Supervision and Inspection Center. This standard was drafted by Shanghai Surgical Instrument Factory. The main drafter of this standard is Huang Mengci.
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