YY/T 0980.3-2016Biopsy needles for single use - Part 3: Mechanical assembly type (English PDF)
一次性使用活组织检查针第3部分机动装配式
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 0980.3-2016 is the English-translated version of 一次性使用活组织检查针第3部分机动装配式.
YY/T 0980.3-2016 is the Chinese pharmaceutical industry standard for the mechanical assembly type of single-use biopsy needle, the needle assembled before use with a reusable mechanical power device that fires it.
It is the third part of the YY/T 0980 series and sets the requirements on top of the general part, covering the needle and its point and sample notch, the fit and the coupling to the power device, the strength of the joints, the rigidity and toughness of the tube, sterility and the marking. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 0980.3-2016
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Structure type5
- 4 Material7
- 5 Requirements and test methods7
- 6 Packaging and marking9
- 7 Instructions for use10
- 8 Transportation and storage10
- 9 Type inspection rules10
- Annex A (informative) Type inspection rules11
- Bibliography12
Foreword
YY/T 0980 "Biopsy needles for single use" series of standards consist of the following parts.
- Part 1: General requirements;
- Part 2: Manual biopsy needle;
- Part 3: Mechanical assembly type - Part 4: Mechanical complete type.
This Part is Part 3 of YY/T 0980 "Biopsy needles for single use".
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This Part of YY/T 0980 specifies the requirements for biopsy needles for single use - mechanical assembly type (hereinafter referred to as "biopsy needles").
This Part applies to mechanical assembly type biopsy needles for single use, which consist of needles for single use and reusable mechanical power devices for automatic or semi-automatic cutting operations to collect biopsy samples.
This Part does not apply to reusable biopsy needles and mechanical power devices connected with the biopsy needle by means of assembly before use.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1220 Stainless steel bar
GB/T 2965 Titanium and titanium alloy bar
YY/T 0980.1-2016 Biopsy needles for single use - Part 1: General requirements
3 Structure type
3.1 A biopsy needle consists of an outer needle tube, an outer needle seat, an inner needle bar, an inner needle seat, a fixed part and a protective cover.
3.2 The sampling type of biopsy needles consists of slot cutting and tube cutting, as shown in Figure 2.
4 Material
4.1 The material of biopsy needles' needle tube and needle seat shall meet the requirements of 5.2 in YY/T 0980.1-2016.
5 Requirements and test methods
5.1 General
In addition to the relevant requirements specified in 5.3 ~ 5.13 of YQ/T 0980.1-2016, biopsy needles shall also meet the following requirements.
5.2 Cutting sampling type
5.2.1 The needle tip top of slot cutting biopsy needles shall not extend beyond the slope root of the inner needle bar, and the front edge of sampling slot of inner needle bar shall not extend beyond the needle tip top of the outer needle tube.
5.3 Inner needle bar's connection fastness
The connection between inner needle bar and inner needle seat of biopsy needles shall be firmly; the axial static tension shown in Table 1 shall be applied to the inner needle bar and the inner needle seat for 10 s, and the two shall not be separated.
5.6 Fixed part
The fixing of the fixed part and the inner and outer needle seats shall be securely locked and shall not fall off naturally before installation.
5.7 Protective cover
The needle tip of biopsy needles shall have a protective cover, which shall not fall off naturally and shall be easy to be removed when used.
6 Packaging and marking
The packaging and marking of biopsy needles shall meet the requirements of Clauses 6 and 7 of YY/T 0980.1-2016.
7 Instructions for use
The instructions for use shall have at least the following information.
8 Transportation and storage
8.1 During transportation and storage process, biopsy needles shall be prevented from stress, sun and rain and snow.
9 Type inspection rules
See Annex A for type inspection rules.
Annex A (informative) Type inspection rules
A.1 Inspection items
The inspection item are the requirements of Clause 5.
A.2 Sampling quantity
Randomly select 10 samples for physical performance; samples for chemical and biological performance are selected according to demand.
A.3 Determination rules
If all inspection items are qualified, the type inspection is PASS. If the inspection items of chemical and biological performance are all qualified and any inspection item of physical performance is unqualified, it is allowed to double the sampling quantity and re-inspect the unqualified item. If the re-inspection is still unqualified, the type inspection is FAIL.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 1220-2007 — Stainless steel bars
GB/T 2965-2023 — Titanium and titanium alloy bars
YY/T 0980.1-2016 — Biopsy needles for single use - Part 1: General requirements
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YY/T 0980.3-2016
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