YY/T 0979-2016Intra-uterine suction curettes for single use (English PDF)

5.5 Negative pressure resistance

Connect one end of the suction curette to a vacuum device and seal the other end. Under (25±2)°C, apply negative pressure according to Table 2 for 30s. Shall conform to the requirements in 4.5.

5.6 Cavity smoothness

5.6.1 Single/ double cavity suction curette

Take a syringe no less than 30mL and take sufficient amount of water. Connect the joint end of the suction curette (or the main tube of a double cavity suction curette) with the cone head of the syringe, push the core rod, so that the water in the syringe is discharged from the suction end of the suction curette. There shall be no obvious resistance. Shall conform to the requirements of 4.6.

5.6.2 Accessory tube of double cavity suction curette

Take one syringe filled with water. Inject water from either side of the accessory tube with the syringe needle. There shall be water discharged from the other side. Shall conform to the requirements of 4.6.

5.7 Sterile

Inspect according to 1101 sterility test method in the "Pharmacopoeia of the People's Republic of China Fourth Part" (2015 edition). Shall conform to the requirements of 4.7.

5.8 Ethylene oxide residue

Test according to the test method of ethylene oxide residue in GB/T 14233.1- 2008. Shall conform to the requirements of 4.8.

5.9 Biological evaluation

5.9.1 Cytotoxicity

Test according to the test method of leaching solution in GB/T 16886.5. Shall conform to the requirements of 4.9.1.

5.9.2 Delayed type hypersensitivity

Test according to the test method in GB/T 16886.10. Shall conform to the requirements of 4.9.2.

5.9.3 Intradermal stimulation test

The markings of the suction curette shall comply with the specifications of Appendix A.

7.2 Instructions for use

7.2.1 There shall be instructions for use in the package.

7.2.2 The instructions shall be compiled in accordance with the requirements of GB/T 9969.

7.2.3 The instruction for use shall contain the following.

a) Name and address of the manufacturer;

b) Product approval number and product standard number;

c) Scope of use and precautions of the product;

d) Product performance, manufacturing materials and possible side effects;

e) Requirements to ensure the correct and safe use of the suction curette, as well as the requirements and precautions when used with other devices;

f) The measures and the precautions to be taken in case of accident occurred during the use of the products;

g) Required contents and descriptions specified in the product standard.

8.1 Packaging

The packaging of the suction curette shall comply with the provisions of Appendix A.

8.2 Transportation

Transportation requirements shall conform to the order contract.

8.3 Storage

The packaged suction curette shall be stored in a clean and well-ventilated room at room temperature with relative humidity no more than 80% and no corrosive gas.

8.4 Period of sterilization expiry

The suction curette sealed in the package shall be indicated with the period of