This standard specifies the classification, requirements, test methods, inspection rules, marking, labeling and packaging methods of the general technical conditions of needle holders. YY/T 1030-2003 General Technical Conditions for Needle Holders YY/T1030-2003 Standard download decompression password: www.bzxz.net

This standard adopts the non-equivalent ISO 151:1988 surgical instruments-non-cutting articulating instruments p4.8.5.3.
This standard replaces YY 91030-1999 & General technical conditions for needle holders. The main changes of this standard compared with YY/T91030-1999 are as follows: "ISO Foreword" is eliminated;
YY/T 1030--2003
General requirements and test methods"
--The title "reference" of Chapter 2 of YY/91030-1999 is changed to "normative reference documents", and the introduction is also changed accordingly according to the requirements of GB/T 1,1-2000. The standard for the promotion of this standard has also been revised. The requirement of "locking force" has been eliminated in the "performance" and the hardness requirement of the carbide sheet has been changed from Rockwell to dimensional recovery. The elasticity and firmness test indicators are selected from 4.3 and 5.3 of ISO711:1988 Surgical instruments-Non-cutting articulated instruments-General requirements and test methods. This standard was proposed by the National Technical Committee for the Promotion of Surgical Instruments. This standard was drafted by Shepai ​​Xinhua Surgical Instruments Co., Ltd. The main drafter of this standard is Sen Renbing. The referenced version of the standard replaced by this standard is: G13 11229-1976, GR 11229—19891YY91030-1999.
1 Scope
General Technical Conditions for Needle Holders
YY/T1030—2003
This standard specifies the classification, requirements, test methods, inspection rules, marking, labeling and packaging methods of general technical conditions for needle holders (hereinafter referred to as needle holders).
This standard applies to needle holders.
2 Normative References
The clauses in the following documents become clauses of this standard before being referenced by this standard. All referenced documents with a notified date, All subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any referenced document without an import date, the latest version applies to this standard. GB/T1912000 Packaging Storage and Transportation Pictorial Marking Core
GB/T23C—1991 Metal Rockwell Hardness Test Method GH12201992 Stainless Steel Bars
GB/T2828—1987 Batch Inspection Counting Sampling Procedure and Sampling Table (Applicable to Continuous Batch Inspection)GR/T 2829—2002
2 Periodic inspection counting sampling procedures and tables (applicable to process stability inspection) YY/T0149-1993 Test method for corrosion resistance of stainless steel medical devices YY/T0194—1991 Determination method for the swing amount of the head end of medical forceps YY/T91052--1999 Surgical instrument marking
3 Classification
The manufacturing material of the needle holder should be 2Cr13M or 2Cr13, 3Cr13, 4Cr13, 3Cr13Mo materials specified in GB1220—1992; the gill shaft should be made of 1Cr13 or 2Cr13 materials. 4 Requirements
4.1 Appearance
4.1.1 The type and basic dimensions of the needle holder should comply with the provisions of the product standard. 4. 1,2 The needle holder should be symmetrical and clean, without sharp edges, burrs, cracks or sand holes. 4.1.3 The lip teeth of the needle holder should be clear and complete. When the locking teeth are fully locked, the tooth surface of the front 3/5 of the lip teeth should be in full contact. 4.1.4 The locking teeth of the needle holder should be complete and free of sharp edges. 4.1.5 The needle holder can be made with or without bright finish. The value of the surface roughness R. should not exceed the value specified in Table 1. Table 1 Surface roughness
Color Part
Shiny
Dull
4. 2 Performance in use
Female leg
Male gill
Unit: micrometer
4.2.1 The needle holder should have good elasticity and semi-solidity. When tested according to 6.3, no distortion, cracking or other permanent deformation should occur. 4.2.2 The needle holder should have good gripping ability. Test according to 6.5. The suture should not slip off. The holding tension should meet the requirements of the product standard.
YY/T1030—2003
When the needle holder is opened and closed, the gills should be relaxed and flexible, and there should be no jamming. 4.2.3
Release the locking teeth, the head ends are 1I:IⅡ1 apart, and the total value of the head end swing caused by swinging the finger ring should be less than or greater than the requirements in Table 2. 4.2. 4
Table 2 Head end swing
Extra length of the clamp L
140L200
Unit is meter
The hardness of the needle holder shall be in accordance with the requirements in Table 3. The difference between the two pieces shall not exceed 4HRC, and the difference between the two pieces of embedded carbide shall not exceed 50HVs5. Table 3 Hardness requirements
2Cr13.2Cr13M
3Cr13,4G-13.36r13Mo
Front part at 1/2 of the headwwW.bzxz.Net
Hard alloy sheet 2923HVe;
18 HRC
40HC-48HRC
4.2.6 The corrosion resistance of the needle holder shall meet the requirements of YY/1C1491993 for the outer surface b level and the gill c level. 5 Inspection rules
5.1 Acceptance
The needle holder shall be inspected by the manufacturing technical inspection department and can only be submitted for acceptance after passing the inspection. 5.2 Batch rules
Needle holders must be submitted for inspection in batches, which are divided into batch inspection (factory inspection) and periodic inspection (type inspection). 5.2.1 The production batch consists of products manufactured under basically the same material, process equipment and production time conditions. 5.2.2 Special batches shall be specified in the order contract. 5.3 Batch inspection
5.3.1 Batch inspection shall be carried out in accordance with the relevant provisions of GB/T2828-1987. 5.3.2 The sampling plan adopts one-time sampling. The strictness of the sampling plan starts from the above routine inspection sampling plan. Its minimum qualified classification, AQL (AQL) inspection level shall be in accordance with the provisions of Table 4 (calculated by the number of unqualified products per 100 units) Table 4 Batch inspection
Technical qualified classification
Unqualified classification
Inspection items
Inspection level
5.4 Periodic inspection
Periodic inspection should be carried out under the following circumstances; 5.4.1
Before new products are put into production (including old products transferred to production): at least once a year in continuous production;
When production is resumed after one month;
When there are major changes in design and process:
e) Products made from each batch of raw materials;
[) When the quality supervision department conducts retrospective supervision and random inspection of product quality. 5.4.2 Periodic inspection shall be carried out in accordance with the provisions of GB/T2822002. 4.1.2
5.4.3 The sampling plan adopts -single sampling. The unqualified classification test group test item daily discrimination level RQL (unqualified quality level) and sampling plan shall be in accordance with the provisions of Table 5 (calculated based on the number of unqualified products per 100 units) Table 5 Periodic inspection
Qualified classification
Test group
Inspection item
Discrimination level
Sampling plan
5_0 11
12L5 6
5.5 When the unqualified products are submitted for inspection again after inspection, the test group that caused the unqualified shall be re-tested. 6 Test method
6.1 Hardness
YY/T 1030—2003
16[56]
1215 67
Measured according to GI3/T230—1991, three points are measured on the upper plane of each rod and the front 1/2 of the head of the non-inserted needle holder or on the carbide insert, and the arithmetic mean is calculated respectively. It shall comply with the provisions of 4, 2.5. 6.2 Corrosion resistance
Performed according to the boiling water test method (A method) specified in YY/T0149—1993. It shall comply with the provisions of 4.2.6. 6.3 Elasticity and firmness
Put a stainless steel wire with a diameter in accordance with Table 6 on the front of the needle holder, close the needle holder completely, and keep this state for 3 hours. The temperature is room temperature, and check whether the needle holder has cracks and permanent deformation. It shall comply with the provisions of 1.2.1. Table 6 Diameter of steel wire for test
Nominal length of needle holder L
Diameter of stainless steel wire
6.4 Swing of head end
160 and below
It shall comply with the relevant provisions of YY/T 0194-1994 and shall comply with the provisions of 4.2.4. 6.5 Clamping function
160
Unit is meter
Use the needle holder to clamp a No. 7 suture at the front 1/3 of the head (fine needle holder clamps No. 7 bonding wire), the needle holder is completely closed, and the tension in accordance with the product requirements is applied to the bonding wire. The suture must not slip off. It should comply with the provisions of 4.2.2. 6.6 Appearance
Daily observation should comply with the provisions of 4.1.2, 4.1.3, 4.1.4. 6.7 Dimensions
Measured by special measuring tools, should comply with the product standards. 6.8 Surface roughness
Measured by sample comparison method or electrical measurement method, the quality is measured by electrical measurement method, and should comply with the provisions of 4.1 and 5. 6.9 Flexibility test
When the needle holder is opened and closed, the gills must be able to move smoothly and not too loose or too tight. The instrument must be able to be easily opened and closed with two fingers. It should comply with the provisions of 4.2.3.
7 Marking
71 Each needle holder should have the following markings according to YYT91052-1999: a) Manufacturer code or trademark:
YY/T 1030-—2003
h) Year of production (the last two characters);
( ) Material marking
7.2 The following markings should be on the inspection certificate: \) Manufacturer name or trademark;
h) Inspector code.
7.3 The following marks shall be on the box:
a) manufacturer's name or trademark, factory address;
product name;
type or specification;
quantity;
e) product standard number;
product registration number.
7.4 The packaging, storage and transportation marks of the outer packaging shall comply with the provisions of GB/T1912000. 8
Packaging, transportation and storage
Each needle holder shall be packed into a neutral plastic bag after anti-rust treatment. The bag shall have a certificate of inspection and be sealed. 8.2 Every 10 needle holders of the same type and specification shall be packed into a box. 8.3 Special requirements shall be packed as needed.
8.4 The packing and transportation requirements shall be in accordance with the order contract. 8.5 The packaged forceps should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases.
After packaging, the needle holding forceps should be guaranteed not to rust within one and a half years under the conditions of complying with the storage rules.
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