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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0174-2005 Scalpel blade.
The following main changes have been made with respect to YY 0174-2005:
——application scope is revised (see Clause 1 hereof; Clause 1 of 2005 Edition);
——manufacturing materials are revised (see 3.3 hereof; 3.2 of 2005 Edition);
——requirements for the blade identification are added (see 3.4);
——requirements for hardness are revised (see 4.4 hereof; 4.4.1 of 2005 Edition);
——requirements for anticorrosion performance are added (see 4.6);
——requirements for residual quantity of ethylene oxide are added (see 4.8);
——requirements for packaging label and instruction are added (see 4.9);
——test methods for surface roughness are revised (see 5.2.1 hereof; 5.2.1 of 2005 Edition);
——test methods for cutting edge sharpness are revised (see 5.3 hereof; 5.3 of 2005 Edition);
——type test is revised (see Clause 6 hereof; Clause 6 of 2005 Edition);
——requirements for labels and instructions are revised (see Clause 7 hereof, Clause 7 of the 2005 Edition);
——requirements for packaging, transportation and storage are revised (see Clause 8 hereof; Clause 8 of 2005 Edition).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by State Drug Administration (SDA).
This standard is under the jurisdiction of National Technical Committee 94 on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94).
The previous editions replaced by this standard are as follows:
——WS2/Z45~WS2/Z46-1982;
——GBn 210-1983;
——GB 2544-1988;
——YY/T 0174-1994, YY 0293-1997;
——YY 0174-2005.
Scalpel blade
1 Scope
This standard specifies the classification and identification, requirements, test methods, type inspection, label and instruction, packaging, transportation and storage and validity period of scalpel blade.
This standard is applicable to surgical blades installed on the scalpel handle for cutting soft tissues (hereinafter referred to as blades).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 191 Packaging—Pictorial marking for handling of goods
GB/T 1299 Tool and mould steels
GB/T 4340.1 Metallic materials—Vickers hardness—Part 1: Test method
GB 8662 Fitting dimension between scalpel blades and handles
GB/T 9969 General principles for preparation of instructions for use of industrial products
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
YY 0167-2005 Non-absorbable surgical suture
YY/T 0294.1 Surgical instruments―Metallic materials―Part 1:Stainless steel
YY/T 0466.1 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements
YY/T 1052 Marking requirements for surgical instruments
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Classification and identification
3.1 Delivery status
Blades are delivered in either sterile or non-sterile states (hereinafter referred to as sterile blades and non-sterile blades).
3.2 Specifications and types
Refer to Annex A for the specifications, types and overall dimensions of the blade and the assembly specifications of the blade handle.
3.3 Material
The blade shall be made of non-alloy tool steel conforming to GB/T 1299 or martensitic stainless steel conforming to YY/T 0294.1, or other applicable metal materials conforming to Clause 4.
3.4 Identification requirements
According to YY/T 1052, the blade surface shall at least be marked with the manufacturer's code, material code (non-alloy tool steel and identification default) and specification, and the identification position is shown in Figure 1.
keys:
L——lengths;
B——breadths (widths);
α, δ, b, b1, L1, L2——assembly dimensions with handles.
Figure 1 Identification location of materials and specifications
4 Requirements
4.1 Dimensions
The assembly dimensions α, δ, b, b1, L1 and L2 of the blade, as shown in Figure 1, shall meet the requirements specified in GB 8662.
4.2 Appearance
4.2.1 The value of blade surface roughness Ra shall not be greater than 0.4 μm, and the value of cutting edge surface roughness Ra shall not be greater than 0.8 μm.
4.2.2 The blade edge shall be free of nicks, naked blade, wire edge, cracks, etc.
4.2.3 The width of both sides of the blade cutting edge shall be similar and the surface shall be free of focal spots.
4.2.4 The blade shall be smooth and free from cracks, sharp edges, burrs and obvious pitting.
4.3 Sharpness of cutting edge
The cutting edge of the blade shall be sharp and its cutting force shall not be greater than 0.80 N.
4.4 Hardness
The blade shall be heat treated with a hardness of not less than 650 HV10.
4.5 Elasticity
The blade shall be well flexible without fracture or obvious deformation after test.
4.6 Anti-corrosion performance
The blade shall have good anti-corrosion performance and free from rust spots on the surface.
4.7 Sterility
If it is a sterile blade, it shall be sterilized by a confirmed sterilization process, and the blade shall be sterile.
4.8 Residual quantity of ethylene oxide
If the blade is sterilized with ethylene oxide, the residual quantity of ethylene oxide shall be not greater than 10 μg/g.
4.9 Packaging labels and instructions
The packaging label shall be clear and conform to the provisions of Clause 7. Instructions shall specify detailed sterilization or disinfection methods.
Foreword i
1 Scope
2 Normative references
3 Classification and identification
4 Requirements
5 Test methods
6 Type inspection
7 Labels and instructions
8 Packaging, transportation, storage and validity period
Annex A (Informative) Specifications and types of blades
Annex B (Normative) Test method for sharpness of cutting edge of surgical blade
Annex C (Normative) Test method for elasticity
