YY/T 0980.1-2016 (YY/T0980.1-2016, YYT 0980.1-2016, YYT0980.1-2016)
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Biopsy needles for single use. Part 1: General requirements
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| Standard ID | YY/T 0980.1-2016 (YY/T0980.1-2016) | | Description (Translated English) | Biopsy needles for single use -- Part 1: General requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 21,232 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Drafting Organization | Shanghai Aisi Yi Medical Plastic Products Co., Ltd., Zhejiang Kang Desai Medical Devices Co., Ltd., Zhejiang Volt Medical Devices Co., Ltd., Shanghai Medical Devices Testing Institute | | Administrative Organization | National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC 95) | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Administration of Food and Drug Administration | | Issuing agency(ies) | State Administration of Food and Drug Administration |
YY/T 0980.1-2016
YY
NATIONAL PHARMACEUTICAL INDUSTRY
STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Biopsy Needles for Single
Use – Part 1. General Requirements
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
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Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Classification and Mark ... 8
4.1 Classification ... 8
4.2 Mark ... 8
4.3 Structure ... 9
5 Requirements ... 12
5.1 Sampling structure of biopsy needle ... 12
5.2 Materials ... 12
5.3 Dimensional tolerance ... 13
5.4 Appearance and cleanliness ... 13
5.5 Needlepoint ... 13
5.6 Sample collection space and smoothness ... 13
5.7 Connecting firmness ... 14
5.8 Rigidity and elasticity ... 14
5.9 Toughness ... 15
5.10 Cone joint of needle seat ... 16
5.11 Biological performance ... 16
5.12 Chemical performance ... 16
5.13 Biological evaluation ... 17
6 Package ... 17
6.1 Sterile primary packaging ... 17
6.2 Outer packaging ... 17
7 Mark ... 17
7.1 Sterile primary packaging ... 17
7.2 Outer packaging ... 18
7.3 Pictogram ... 18
Appendix A (Informative) Structure changes between this Part and JIS T
3228.2011 ... 19
Appendix B (Informative) Technical differences and causes between this Part
and JIS T 3228.2011 ... 22
Appendix C (Informative) Guidelines for biopsy needle rigidity and structural
size ... 29
Bibliography ... 31
Foreword
YY/T 0980 Biopsy Needles for Single Use can be divided into the following 4 parts.
-- Part 1. General Requirements;
-- Part 2. Manual Biopsy Needle;
-- Part 3. Mechanical Assembly Type;
-- Part 4. Mechanical Complete Type.
This Part belongs to Part 1 of YY/T 0980 Biopsy Needles for Single Use.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part modifies and adopts JIS T 3228.2011 Biopsy Needles for Single Use.
Compared with JIS T 3228.2011, this Part has more adjustments in structure; Appendix
A list the Clause Number Comparison List between This Part and JIS T 3228.2011.
There is technical difference between this Part and JIS T 3228.2011; Appendix B gives
the Corresponding Technical Differences and Causes List.
Please note that some contents of this document may involve patents. The issuer of
this document does not assume the responsibility for identifying these patents.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee for
Standardization of Medical Syringe (Needle) (SAC/TC 95).
Drafting organizations of this Part. Shanghai SA Medical & Plastic Instruments Co.,
Ltd., Zhejiang Kindly Medical Devices Co., Ltd., Zhejiang Fert Medical Device Co., Ltd.,
and Shanghai Testing & Inspection Institute for Medical Devices.
Participating drafting organizations of this Part. Weihai Jierui Medical Products Co.,
Ltd., and Shandong Shinva Ande Healthcare Apparatus Co., Ltd.
Chief drafting staffs of this Part. Cao Xianming, Liu Yiwei, Zhang Qian, Su Weidong,
and Huang Shuze.
Biopsy Needles for Single
Use – Part 1. General Requirements
1 Scope
This Part of YY/T 0980 specifies the general requirements of biopsy needle for single
use (hereinafter referred to as biopsy needle).
This Part is applicable to the biopsy needle for single use for sample collection of living
tissue for inspection.
This Part is not applicable to biopsy needle for repeated use, and the mechanical
power device connected with the biopsy needle by means of assembly.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 1220-2007 Stainless-steel Bars
GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and
Certain Other Medical Equipment - Part 1. General Requirement
GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and
Certain Other Medical Equipment - Part 2. Lock Fittings
GB/T 2965 Titanium and Titanium Alloy Bars
GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for
Medical Use - Part 1. Chemical Analysis Methods
GB/T 14233.2 Test Methods for Infusion Transfusion Injection Equipment for
Medical Use - Part 2. Biological Test Methods
GB 15980 Hygienic Standard of Disinfection for Single Use Medical Products
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1. Evaluation and
Testing within a Risk Management Process
GB 18279.1 Sterilization of Health Care Products - Ethylene Oxide - Part 1.
Requirements for Development, Validation and Routine Control of a Sterilization
Process for Medical Devices
GB/T 18279.2 Sterilization of Health Care Products - Ethylene Oxide - Part 2.
Guidance on the Application of GB 18279.1
GB/T 18280.1 Sterilization of Health Care Products – Radiation - Part 1.
Requirements for Development, Validation and Routine Control of a Sterilization
Process for Medical Devices
GB/T 18457-2015 Stainless-steel Needle Tubing for the Manufacture of Medical
Devices
GB/T 19633.1 Packaging for Terminally Sterilized Medical Devices - Part 1.
Requirements for Materials, Sterile Barrier Systems and Packaging Systems
YY/T 0313-2014 Medical Polymer Products - Requirement for Package and
Information Supplied by Manufacturer
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied - Part 1. General Requirements
3 Terms and Definitions
The following terms and definitions are applicable to this document.
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.
3.14 Outer package
The package unit that is applicable to the product transportation.
[YY/T 0313-1998, definition 3.6]
4 Classification and Mark
4.1 Classification
4.1.1 According to the method to obtain the biopsy sample through the biopsy needle,
it can be di...
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