This standard specifies the requirements, inspection rules, test methods, classification and marking, logo, instruction manual, packaging, transportation, storage, etc. of sterile plastic handle scalpels. This standard applies to sterile plastic handle scalpels for single use after sterilization. This product is used for cutting soft tissue in surgical operations. YY/T 0454-2003 Sterile Plastic Handle Scalpel YY/T0454-2003 Standard download decompression password: www.bzxz.net

YY/T0454—2003
In order to standardize the technical requirements of sterile plastic handle scalpels, this standard makes unified provisions for the requirements, inspection rules, test methods, classification and marking, signs, instructions for use, packaging, transportation, storage, etc. of sterile plastic handle scalpels. Appendix A of this standard is a normative appendix.
This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Instruments of the State Food and Drug Administration. The drafting unit of this standard: Zhunyin Medical Device Co., Ltd. The main drafters of this standard: Si Huaixi, Lu Guangheng, Shi Jun. I
1 Scope
Sterile plastic handle scalpels
YY/T 0454—2003
This standard specifies the requirements, inspection rules, test methods, classification and marking, signs, instructions for use, packaging, transportation, storage, etc. of sterile plastic handle scalpels.
This standard applies to sterile plastic-handled scalpels (hereinafter referred to as scalpels) for single use after sterilization. This product is used for cutting soft tissues in surgical operations.
2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard. GB/T191—2000 Pictorial marking for packaging, storage and transportation GB/T 1220—1992
Stainless steel bars
) Alloy tool steel
GB/T 1299—2000
GB/T 2828—1997
Counting sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) GB9969.1-1998General principles for instructions for use of industrial products GB/T14233.1--1998Test methods for medical blood transfusion and infusion syringes Part 1: Chemical analysis methods GB/T14436—1993General principles for guarantee documents for industrial products YY/T0174—1994Surgical blades
"Pharmacopoeia of the People's Republic of China" 2000 edition, Part II
3 Requirements
The surface of the plastic handle should be smooth and free of injection molding defects. 3.2 The handle pattern of the plastic knife handle should be neat and clear. 3.3 The mark of the scalpel should be clear and complete. 3.4 The surgical blade assembled with the plastic knife handle should comply with the provisions of 4.3 of YY/T01741994. 3.5 The blade and the handle should be assembled firmly.
3.6 The scalpel should have a blade protection device.
3.7 The scalpel is sterilized with ethylene oxide, and its residual amount should not exceed 10μg/g. 3.8 The scalpel should be sterile. bzxZ.net
3.9 The small package mark should be clear.
4 Inspection rules
4.1 Acceptance
The scalpel should be inspected by the technical inspection department of the manufacturer and can only be submitted for acceptance after passing the inspection. 4.2 Batch rules
Each inspection batch should consist of unit products with the same batch number, the same type, and continuous production and production time. When several production batches constitute an inspection batch, they should be products produced under the same sterilization conditions. 4.3 Factory inspection
YY/T0454—2003
4.3.1 Surgical knives are submitted for inspection in batches and shall comply with the relevant provisions of GB/T2828-1987. 4.3.2 The factory inspection of surgical knives adopts a single sampling plan. The initial inspection is a normal inspection. Its non-conforming classification, inspection items, inspection level, and qualified quality level (AQL) are in accordance with the provisions of Table 1. Table 1
Non-conforming classification
Inspection items
Inspection level
Qualified quality level
4.4 Type inspection
All qualified
Batch inspection counting sampling table
4.4.1 The type inspection items and sampling quantity of surgical knives shall comply with the provisions of Table 2. Table 2 Inspection items and sampling quantity
Inspection items
Sampling quantity
Note 1: 3.8 and 7.1.1 should be checked at the same time when checking other items. Note 2: A total of 50 pieces and 12 small packages should be sampled. Type inspection should be carried out in any of the following circumstances: 4.4.2
When new products or old products are transferred to the factory for production;
Not less than once a year in continuous production;
When there are major changes in structure, materials, and processes; c)
When the national quality supervision and inspection agency proposes a requirement for type testing d))
5 Test method
5.1 Appearance test
By visual observation, it should comply with the provisions of 3.1, 3.2, 3.3, and 3.6. 5.2 Surgical blade test
3.3, 3.5, 3.6,
According to the requirements of 5.3.1 in YY/T0174-1994, the results should meet the requirements of 3.4. 5.3 Assembly firmness test
12 small packages
Add a 10N load to the middle of the plastic handle without impact and keep it for 30s. The surgical blade shall not fall off. See Appendix A for the test method. 5.4 Ethylene oxide residue test
According to the test method in GB/T14233.1-1998, the test results should meet the requirements of 3.7. 5.5 Sterility test
Randomly select 10 surgical knives, inoculate them in culture medium in a sterile room for cultivation, and perform the sterility test in the appendix of the 2000 edition of the Pharmacopoeia of the People's Republic of China. It should meet the requirements of 3.8. 5.6 Small package marking
Visual observation shall comply with the provisions of 3.9. 6 Classification and marking
6.1 Classification
According to the connection method between the surgical blade and the plastic handle, surgical knives can be divided into two categories: 2
a) assembled surgical knives;
b) fused surgical knives.
6.2 Marking
Surgical blade specification code
Plastic handle material code
Manufacturer code
Example: HY-S-11 is a surgical knife assembled with a plastic handle and a No. 11 surgical blade produced by HY Factory. 6.3 Materials
YY/T 0454—2003
6.3.1 The plastic handle of a scalpel should be made of non-toxic ABS (acrylonitrile-butadiene-styrene) or materials suitable for plastic handles. 6.3.2 The surgical blade should be made of Cr03 alloy tool steel or Cr06 material specified in GB/T1299-—2000 and stainless steel material specified in GB/T1220-1992, or made of materials suitable for surgical blades. 7 Markings and Instructions for Use
7.1 Markings
7.1.1 The following markings shall be on the small package:
Manufacturer name or trademark,
Product name;
Specifications,
Production batch number;
Sterilization method;
Sterilization validity period;
Words such as secondary use or sterile;
“Do not use if the sterilized package is damaged” or words indicating equivalent content. The following markings shall be on the medium package:
Manufacturer name or trademark;
Product name;
Specifications;
Quantity;
Product registration number;
Implementation standard number;
Sterilization method;
Sterilization validity period.
The following marks should be on the large package:
Product name;
Specifications;
Quantity;
Name and address of manufacturer;
Production batch number and sterilization date;
YY/T0454—2003
f) Product registration number;
g) Implementation standard number;
h) Gross weight;
i) Net weight;
j) Volume (length × width × height);
k) Words or marks such as "rainproof" should comply with the provisions of GB/T191---2000. 7.2 Instructions for use
7.2.1 The instructions for use should include the following contents: product name, implementation standard number, abbreviation; a) i) manufacturer name and detailed address;
product structure and usage requirements;
d) product type, specification, model,
precautions.
7.2.2 The instructions for use should comply with the provisions of GB9969.1-1998. 8 Packaging, transportation, storage
8.1 Packaging
8.1.1 The surgical blade protection device should be easy to remove or take off. 8.1.2 The small package is the smallest package for one-time use, and the small package should be able to ensure normal use within the validity period. 8.1.3 The medium package should contain the instruction manual and product certificate. The preparation of the product certificate should comply with the provisions of GB/T14436. 8.1.4 The large package should be strong enough to ensure that the product will not be damaged under normal transportation and storage conditions. The words or logos on its surface should be clear and complete within the validity period. Special packaging requirements shall be in accordance with the provisions of the order contract. 8.2 Transportation
The product should be protected from heavy pressure, direct sunlight and rain during transportation. 8.3 Storage
The packaged scalpel should be stored in a clean and well-ventilated room with a relative humidity of no more than 80%, no corrosive gas. 9 Others
After sterilization, the scalpel shall be valid for no less than 2 years and no more than 5 years under the conditions of storage regulations. 4
A.1 Instrument requirements
Adjustment block
Surgical blade
Adjust the position of the adjustment block.
(Normative Appendix)
Assembly firmness test
A.1.2 Make the distance to the fixed block equal to the length of the plastic knife handle. A.2 Test method
Remove the blade protection sheet or knife sheath of the scalpel. A.2.1
A.2.2 Place the scalpel in the position shown in the figure.
Plastic knife handle
A.2.3 Apply a load of 10N to the middle of the plastic knife handle without impact and maintain it for 30s. A.2.4 Remove the load and observe that the surgical blade does not fall off. 10mm
YY/T0454—2003
Fixed block
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