YY 0174-2005Scalpel blades (English PDF)

3.1 Delivery state

The blade has two delivery states. aseptic and non-sterile (hereinafter referred to as sterile blade and non-sterile blade).

3.2 Specification type

Refer to Annex A for the specifications and dimensions of the blade, as well as the assembly specifications of the handle.

3.4 Marking requirements

According to YY/T 1052, the surface of the blade shall at least be marked with the manufacturer code, material code (non-alloy tool steel, marking default) and specifications. See Figure 1 for marking positions.

4.1 dimensions

The blade assembly dimensions alpha, delta, b, b1, L1 and L2, see Figure 1, shall comply with the provisions of GB 8662.

4.2 Appearance

4.3 Edge sharpness

The blade edge shall be sharp. The cutting force shall not be greater than 0.80N.

4.4 Hardness

The blade shall be heat treated. Its hardness is not less than 650HV10.

4.5 Elasticity

The blade shall have good elasticity. After the test, there is no fracture and no obvious deformation.

4.6 Anti-rust performance

The blade shall have good rust resistance. There shall be no rust spots on the surface.

4.9 Packaging labels and instructions on use

The packaging labels shall be clear and meet the requirements of Clause 7.

The instructions on use shall specify detailed sterilization or disinfection methods.

5.1 Dimensions

Use universal measuring tools to measure, in accordance with the provisions of 4.1.

5.2 Appearance

5.3 Edge sharpness

See Annex B for test methods, in accordance with the provisions of 4.3.

5.4 Hardness

Conduct the test according to the method specified in GB/T 4340.1.Test three points on the blade. Take its arithmetic mean, in accordance with the provisions of 4.4.

5.5 Elasticity

See Annex C for the test method, in accordance with the provisions of 4.5.

5.6 Anti-rust performance

5.7 Sterility

Conduct it according to the General Principle 1101 "Test of Sterility" of

Pharmacopoeia of the People's Republic of China (Edition 2015· Fourth

Edition), in accordance with the provisions of 4.7.

5.8 Residual ethylene oxide

Conduct according to the method specified in GB/T 14233.1, in accordance with the provisions of 4.8.

7.1 Labels

7.1.1

The minimum package of non-sterile blades shall have at least the following contents or symbols.

7.1.2

The minimum package of sterile blades shall have at least the following contents or symbols.

7.1.3

The minimum sales unit packaging shall have at least the following contents or symbols.

7.1.4

There shall be an inspection certificate in each minimum sales unit. At least the following content shall be included on the certificate.

7.1.5

The packaging, storage and transportation marks on the package shall comply with the relevant regulations of GB/T 191 and YY/T 0466.1.

7.2 Instructions on use

There shall be instructions on use in each minimum sales unit. The preparation of the instructions on use shall comply with the requirements of GB/T 9969, at least containing the followings.

8.1

The initial packaging consists of a single sterile blade or multiple non-sterile blades. The initial packaging shall be the minimum packaging.

8.2

The medium packaging consists of 1 or more small packages. The medium packaging shall be the minimum sales unit.

8.3

After the initial packaging of the sterile blade is opened, there shall be traces of the opening.

8.6

The packaged blades shall be stored in a room temperature, clean, well- ventilated, and non-corrosive gas environment. The expiration date shall not be less than 2 years.

YY 0167-2020 | YY/T 0243-2016 | YY/T 0245-2008 | YY/T 0242-2007 | YY/T 0492-2026 | […]