This standard specifies the classification and naming, requirements, test methods, inspection rules, marking and instructions for use, packaging, transportation and storage of tooth extraction forceps. This standard applies to gill-penetrating or gill-folding tooth extraction forceps. YY/T 0453-2003 General Technical Conditions for Tooth Extraction Forceps YY/T0453-2003 Standard download decompression password: www.bzxz.net

This standard is a revised version of GB8666.1-1988 "General Technical Conditions for Tooth Extraction Forceps". Compared with GB8666.1-1988, the main technical differences of this standard are as follows: the hardness value is changed from 42-47HRC to 40HRC-48HRC. The inspection rules of YY/T0453-2003
are changed from WS2-279~-1981 "Rules for Counting Sampling Inspection of Medical Device Products" to GB/T2828-1987 "Batch Inspection Counting Sampling Procedure and Sampling Table (Applicable to Inspection of Continuous Batch)". Periodic inspection is added to facilitate blue supervision spot check. From the date of implementation, this standard will also replace GB8666.1-1988 "General Technical Conditions for Tooth Extraction Forceps". This standard is proposed and managed by the National Surgical Instrument Standardization Committee. The main drafting unit of this standard: Surgical Instrument Factory of Shanghai Medical Instrument (Group) Co., Ltd. The main drafter of this standard: Zhang Hongxia.
The previous versions of the standards replaced by this standard are: GB8666.1—1988.
1 Scope
General technical conditions for dental extraction forceps
YY/T0453—2003
This standard specifies the classification and naming, requirements, test methods, inspection rules, marking and instructions for use, packaging, transportation and storage of dental extraction forceps.
This standard applies to gill-penetrating or gill-folding dental extraction forceps. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this standard. GB/T191—2000 Pictorial marking for packaging, storage and transportation GB/T230—1991 Rockwell hardness test method for metals GB1220—1992 Stainless steel bars
GB/T2828—1987 Batch-by-batch inspection, counting sampling procedures and sampling tables (applicable to inspection of continuous batches) 2-cycle inspection, counting sampling procedures and tables (applicable to inspection of process stability) GB/T2829—2002
GB9969.1—1998 General provisions for instructions for use of industrial products YY/T0149—1993 No Test method for corrosion resistance of stainless steel medical instruments YY/T0173.1-1994 Surgical instruments, cylindrical countersunk gill shaft screws YY/T0173.3-1994 Surgical instruments Gill shaft for forceps YY/T91052-1999 Surgical instrument markings
3 Classification
3.1 The type and basic dimensions of tooth extraction forceps shall comply with the provisions of product standards. 3.2 The gill shaft screws of tooth extraction forceps shall comply with the provisions of YY/T0173.1-1994; the gill shaft for forceps shall comply with the provisions of YY/T0173.3-1994.
3.3 The materials selected for tooth extraction forceps shall comply with the provisions of Table 1. Table 1 Materials
Part Name
Tooth Forceps Body
Gill Shaft Screw
Gill Shaft for Forceps
4 Requirements
4.1 Performance
2Cr13Mo
2Cr13, 1Cr13
Standard Number
GB1220
4.1.1 The screw of the tooth extraction forceps should be firmly fixed on the left piece. When the tooth extraction forceps is closed or opened, the screw should not follow the movement. 4.1.2 The opening and closing of the tooth extraction forceps should be easy and flexible, and there should be no jamming. 4.1.3 The thickness of the tooth extraction forceps and the gap size at the head end should comply with the provisions of the product standard. YY/T0453—2003
4.2 Physical and chemical properties
4.2.1 The hardness of the tooth extraction forceps is 40HRC~48HRC4.2.2 After the tooth extraction forceps bear the pressure specified in the product standard, the head end should not be broken or deformed. The surface of the tooth extraction forceps can be made bright or dull, and the value of its surface roughness R. should not be greater than the provisions of Table 2. 4.2. 3
Table 2 Surface roughness
Bright
Non-bright
Gill-penetrating
Gill-folding
Gill selection
3 Stability
The tooth extraction forceps should have good corrosion resistance and should meet the requirements of b-level for the outer surface and c-level for the gills after the test. 4.4 Appearance
Unit: micrometer
4.4.1 The tooth extraction forceps should be free of sharp edges, burrs, and cracks, and the outer edges of the front and rear ends of the gills (including the two ends of the gills of the male piece) should be blunt. 4.4.2 The handle of the tooth extraction forceps should be clear, without missing flowers or oxide scale. 5 Test method
Performance in use
5.1.1 Screw fixation test: simulate the use action and visually inspect, which should comply with the provisions of 4.1.1. 5.1.2
Flexibility: simulate the use action and inspect by hand, which should comply with the provisions of 4.1.2. 5.1.3 Size test: measure with general measuring tools or special measuring tools, which should comply with the provisions of 4.1.3. 5.2 Physical and Chemical Properties
5.2.1 Hardness Test
According to the provisions of GB/T230-1991, three points are measured on the two heads of the tooth extraction forceps, and the arithmetic mean of the three points is taken, which shall comply with the provisions of 4.2.1.
5.2.2 Strength Test
According to the test principle shown in Figure 1, a stainless steel block with a thickness 5mm larger than the gap of the tooth extraction forceps head specified in the product standard and a shape that basically matches the beak of the tooth extraction forceps head is placed at the front end of the head. After applying the pressure specified in the standard push at the marked position of the handle, it shall comply with the provisions of 4.2.2.
Force Direction
Figure 1 Principle of Strength Test of Tooth Extraction Forceps
5.2.3 Surface Roughness Test
YY/T 0453--2003
Measurement by sample block comparison method or electrical measurement method shall comply with the provisions of 4.2.3. Quality arbitration is conducted by electrical measurement. 5.3 Stability performance
Corrosion resistance test: Conducted in accordance with the boiling water test method (A) specified in YY/T0149-1993, and shall comply with the provisions of 4.3. 5.4 Appearance
Visual inspection of the feel shall comply with the provisions of 4.4.
6 Inspection rules
6.1 Acceptance
Tooth extraction forceps shall be inspected by the technical inspection department of the manufacturer, and only after they are qualified can they be submitted to the ordering party for acceptance. 6.2 Batch rules
Tooth extraction forceps must be submitted for inspection in batches, and the inspection is divided into batch inspection (factory inspection) and periodic inspection (type inspection). 6.3 Batch inspection
6.3.1 The batch inspection of tooth extraction forceps shall be carried out in accordance with the provisions of GB/T2828-1987. 6.3.2 The batch inspection of tooth extraction forceps adopts one-time sampling. The strictness of the sampling plan starts from the normal inspection plan. Its non-conforming classification, inspection items, inspection level and AQL (acceptable quality level) shall be in accordance with the provisions of Table 3 (counted by the number of non-conforming products per 100 units of products). Table 3 Batch inspection
Non-conforming classification
Non-conforming classification group
Inspection items
Inspection level
6.4 Periodic inspection
Periodic inspection shall be carried out in the following cases: before the new product is put into production (including the conversion of old products); products in continuous production shall be carried out at least once a year; when the interval is more than one year before the production is put into production;
When there are major changes in design, process and materials;1
When the national quality supervision and inspection agency supervises and inspects the product quality. Periodic inspection shall be carried out in accordance with the provisions of GB/T2829-—2002. c
Periodic inspection adopts a sampling plan, and its non-conforming classification, test group, inspection items, discrimination level, RQL (non-conforming quality level) and sampling plan shall be in accordance with the provisions of Table 4 (counted by the number of non-conforming products per 100 units of products). Table 4 Periodic inspection
Non-conforming classification
Test group
Inspection items
Discrimination level
Sampling plan
10[67]
YY/T 0453—2003
7 Marking and instructions for use
7.1 Marking
7.1.1 Each pair of dental extraction forceps shall have the following markings in accordance with YY/T91052—1999: a) manufacturer code or trademark;
b) production year (the last two characters);
c) material mark.
7.1.2 The inspection certificate shall have the following marks: a) manufacturer name or trademark;
b) inspector code.
7.1.3 The box shall have the following marks and instructions for use: a)
manufacturer name or trademark, factory address;
b) product name;
type or specification;
c) quantity;
d) product standard number;
e) product registration number; bZxz.net
f) product scope of application.
7.1.4 The packaging, storage and transportation marks of the outer packaging shall comply with the provisions of GB/T191-2000. 7.2 Instructions for use
7.2.1 If there are no instructions for use on the box, there should be instructions for use inside the box. 7.2.2
The preparation of instructions for use should comply with the provisions of GB9969.1-1998. 8 Packaging, transportation, storage
8.1 After rust-proofing, each tooth extraction forceps shall be packed in a neutral plastic bag, and the bag shall contain a certificate of inspection. 8.2: Each pair of tooth extraction forceps of the same type and specification shall be packed in a box. 8.3 Special requirements can be packaged according to the order contract. 8.4 The packing and transportation requirements shall be in accordance with the order contract. 8.5 The packaged tooth extraction forceps shall be stored in a room with a relative humidity not exceeding 80%, no corrosive gases and good ventilation. 9 Others
After packaging, the tooth extraction forceps shall be guaranteed not to rust within one and a half years under the condition of complying with the storage rules. 0050
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