YY 0174-2019Scalpel blade (English PDF)

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

4.2.1

The value of the blade surface roughness R a shall not be greater than

0.4µm. The value of the surface roughness R a of the cutting-edge surface shall not be greater than 0.8µm.

4.2.2

The blade edge shall be free of nicks, white edges, curls, cracks and so on.

4.2.3

The width of both sides of the cutting edge of the blade shall be similar, without focal spots on the surface.

4.2.4

The blade shall be flat, without cracks, sharp edges, burrs, obvious pits.

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.

4.7 Sterility

If it is a sterile blade, it shall be sterilized through a confirmed sterilization process. The blade shall be sterile.

4.8 Ethylene oxide residue

If the blade is sterilized with ethylene oxide gas, the residual amount of ethylene oxide shall not exceed 10µg/g.

7.1.2

The minimum package of sterile blades shall have at least the following

contents or symbols:

a) Product name and specifications;

b) Sterilization method, sterility, single-use mark;

c) Product registration certificate number;

d) Words or symbols of "Do not use if the package is damaged";

e) Batch code or batch number, production date, expiration date or expiration date;

f) Name and domicile of the registrant or manufacturer;

g) Words or symbols of "Other contents are detailed in the instructions on use".

7.1.3

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

a) Product name;

b) Specifications, quantity;

c) Sterilization method (for sterile blades), single-use mark;

d) Batch code or batch number, production date, expiration date or expiration date;

e) Product registration certificate number or record certificate number, production license number or production record certificate number;

f) Name of the registrant or filing person, the name of the manufacturer, the address, and the contact information.

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:

a) Name of the registrant or filing person or manufacturer;

b) Number of product technical requirements;

c) Batch code or batch number;

d) Inspection date and inspector code.

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:

a) Product name, specifications;

b) Name, address, contact information and after-sales service information of the registrant or filing person or manufacturer; If it is entrusted production, it shall also indicate the name, address and production license number of the entrusted production enterprise or production record document number;

c) Product registration certificate number or record certificate number, production license number or production record certificate number;

d) Number of product technical requirements;

e) Product performance, manufacturing materials, scope of application;

f) Installation and use instructions or icons;

g) Storage conditions and methods;

h) Description on one-time use, detailed sterilization or disinfection method, production date, use period or expiration date;

i) Explanation of the graphics, symbols, abbreviations used in the label;

j) Preparation of instructions on use or revision date;

k) Contraindications, precautions, warnings and reminders:

1) Requirements to ensure the correct and safe use of the blade, and post- processing requirements for safe use;

2) Precautions when the blade is used in conjunction with other instruments;

3) The sterile blade shall indicate the treatment method when the minimum single package is damaged.