YY/T 0980.1-2016Biopsy needles for single use - Part 1: General requirements (English PDF)

3.1 Biopsy

The method to obtain living tissue sample from the patient body for the pathological examination and disease diagnosis.

3.2 Biopsy needle

Needle medical device for collecting the living tissue sample.

3.3 Aspiration biopsy needle

The biopsy needle collecting the living tissue sample through aspiration, the front end of the needle body shall be designed as a puncture structure and retain sample aspiration collection space; it can be used alone or coordinate with aspirator to use.

3.4 Cutting biopsy needle

The biopsy needle collecting the living tissue sample through cutting the living tissue, the front end of the needle body shall be designed as puncture structure and retain sample cutting collection space.

3.5 Manual biopsy needle

The biopsy needle collecting the living tissue sample through manual operation.

The biopsy needle, before use, the biopsy needle body is assembled with the reusable mechanical power device; automatically or semi-automatically collecting the living tissue sample by means of mechanical power device.

4.1 Classification

4.1.1 According to the method to obtain the biopsy sample through the biopsy needle, it can be divided into.

4.1.2 According to the method to use biopsy needle, it can be divided into.

4.1.3 According to the usage of biopsy needle, it can be divided into.

4.2 Mark

4.2.1 Model mark

The model mark of biopsy needle consists of English letters and Arabic numerals; the expression method is as follows.

4.3 Structure

The needle part of the biopsy needle is composed of single needle tube and needle Design style code

5.1 Sampling structure of biopsy needle

The sampling structure of biopsy needle shall at least include one of the following modes.

5.2 Materials

5.2.1 Needle tube materials

The needle tube shall be made of the following materials.

5.2.2 Needle seat or relevant accessories materials

The materials of needle seat or relevant accessories that in direct or indirect contact with the human body shall meet the requirements of 5.11, 5.12, and 5.13 in this Part.

5.5 Needlepoint

The needlepoint cutting edge shall be sharp; use the 2.5× magnifier to check there shall be no visible hook head, flat head, burs or the like defects.

5.7 Connecting firmness

5.7.1 According to nominal outside diameter or outside diameter on the minimum cross-section of the biopsy needle, exert the axial static tension specified in Table 2 on the needle tube and needle seat, last for 10s, the two of which shall not be separated.

5.8 Rigidity and elasticity

5.8.1 For the needle tube adopting the stainless-steel materials specified in GB/T 18457-2015, and applicable to the inside and outside diameter sizes listed in Table 1, its rigidity shall meet the requirements of such standard.

5.9 Toughness

5.9.1 For the needle tube adopting the stainless-steel materials specified in GB/T 18457-2015, and applicable to the inside and outside diameter size series listed in

5.11 Biological performance

5.11.1 Sterile

The biopsy needle ensures the sterility of the product through confirmation of sterilization process and routine control.

5.13 Biological evaluation

Perform the biological evaluation against the biopsy needle as per the method specified in GB/T 16886.1.

6.1 Sterile primary packaging

The sterile primary packaging shall meet the requirements of GB/T 19633.1; ensure that it is not easy to be broken before use, and can prevent the microbial invasion.

6.2 Outer packaging

The outer packaging shall have the strength to protect the content products under the normal disposing, transporting and storing conditions.

7.1 Sterile primary packaging

The sterile primary packaging shall have the following marks at least.

7.2 Outer packaging

The outer packaging shall have the following marks at least.

7.3 Pictogram

The pictogram shall conform to the provisions of YY/T 0466.1.