YY/T 0980.2-2016Biopsy needles for single use - Part 2: Manual biopsy needle (English PDF)

3.1 General

The structures of the biopsy needles can be divided into manual aspiration, manual cutting, and combination of the former two types.

3.2 Structure

3.2.1 The structure of manual aspiration biopsy needle is shown in Figure 1.

3.2.2 The structure of manual cutting biopsy needle is shown in Figure 2.

3.2.3 The structure of manual aspiration and manual cutting combined biopsy

needle is shown in Figure 3.

5.1 General

In addition to meet the requirements of Clause 5 in YY/T 0980.1-2016, the biopsy needle shall also meet the requirements of 5.2 ~ 5.8.

5.2 Needlepoint structure

5.2.1 If the external needle tube of the biopsy needle adopts inclination edge needlepoint, use 3× magnifier to observe; its internal needle tube or internal needle bar needlepoint puncturing with external needle tube shall not protrude out of the edge bevel of the external needle tube.

5.3 Inner hole cleanliness

The inner hole of biopsy needle shall be clean; take the amount (stipulate din Table 1) of mixture between glycerol and alcohol at the rate of 1.1 to inject through the biopsy needle; use the normal or corrected vision to check whether the mixture contains the foreign objects or impurities.

5.4 Internal needle connecting firmness

The internal needle tube or internal needle bar of biopsy needle shall be connected with internal needle seat firmly, after exerting the axial static tension shown in Table 2 on the internal needle tube/bar and internal needle seat, last for 10s, the two of which shall not be separated.

5.6 Scale identification

If the external needle tube of biopsy needle has scale line for prompting the puncture depth (as shown in Figure 4), the scale line shall form a circle on the external surface of the needle tube, and is clearly visible.

5.7 Positioner

5.7.1 If the biopsy needle is equipped with the puncture depth positioner, when exerting 10N axial static pressure on the front end of the positioner, last for 10s, the positioner shall have no axial movement.

5.8 Sheath

The sheath for protecting the needlepoint shall be equipped with out of the needlepoint of the biopsy needle, and the sheath shall not fall off naturally.

A.1 Inspection items

The inspection items can refer to the requirements of Clause 5.

A.2 Sampling amount

Physical performance shall randomly sample 10 pieces; while the chemical and biological performance shall sample as per the demand.

A.3 Judgement rules

When all inspection items are qualified, the product passes through the type inspection.

During the inspecting process, if the chemical and biological performances are qualified, but the physical performance is disqualified, the sampling amount is allowed to be doubled, and re-inspect the disqualified item. If the re-inspection is still disqualified, then the product doesn't pass through the type inspection.