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YY/T 0916.1-2021: (Small-aperture connectors for medical drugs and gases - Part 1: General requirements)
Status: Valid YY/T 0916.1: Evolution and historical versions
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(Small-aperture connectors for medical drugs and gases - Part 1: General requirements)
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YY/T 0916.1-2021
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| YY/T 0916.1-2014 | English | 799 |
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Small-bore connectors for liquids and gases in healtncare applications. Part 1: General requirements
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YY/T 0916.1-2014
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Basic data | Standard ID | YY/T 0916.1-2021 (YY/T0916.1-2021) | | Description (Translated English) | (Small-aperture connectors for medical drugs and gases - Part 1: General requirements) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 31,322 | | Issuing agency(ies) | State Drug Administration | YY/T 0916.1-2021: (Small-aperture connectors for medical drugs and gases - Part 1: General requirements)
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(Small-aperture connectors for medical drugs and gases Part 1.General requirements)
ICS 11.040.10;11.040.20
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0916.1-2014
Small Bore Connectors for Medical Liquids and Gases
Part 1.General Requirements
Part 1.Generalrequirements
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Material 3
5 Small Bore Connector Incompatibility4
6 Clinical application 4
6.1 Design of new small-diameter connectors 4
6.2 Gastrointestinal applications 4
6.3 Limb Airbag Inflation Application 4
6.4 Axon Application 4
6.5 Intravascular or Subcutaneous Application 4
7 Other small aperture connectors5
Appendix A (informative) Appendix A "Explanation" of ISO 80369-1.2018 used in this part 6
Appendix B (Normative Appendix) Physical Test Methods for Demonstration of Non-Interconnection Properties 9
Appendix C (Informative Appendix) Symbols and Safety Marks 18
Appendix D (Normative Appendix) Evaluation Procedures for Small Bore Connectors 19
Appendix E (Informative) Application of Small Bore Connectors 21
Appendix F (Informative Appendix) Basic Principles 22
Reference 23
index 24
Figure B.1 Typical diameter 10 of a male connector to be evaluated for a retaining collar
Figure B.2 Diameter 10 of a typical full threaded female connector to be evaluated
Figure B.3 Typical rib diameter to be evaluated10
Figure B.4 Typical lug connector to be evaluated 11
Figure B.5 Typical barrel-to-barrel interface to be evaluated11
Figure B.6 Typical barrel to full thread interface to be evaluated11
Figure B.7 Typical barrel-to-full thread interface to be evaluated (section view) 11
Figure B.8 Typical barrel-to-external lug interface to be evaluated12
Figure B.9 Typical barrel-to-external lug interface to be evaluated (section view) 12
Figure B.10 Typical thread-to-thread interface to be evaluated (section view) 12
Figure B.11 Example of structure or geometry to prevent misconnection12
Figure B.12 Establishment of leak test method 17
Table B.1 Dimensional analysis from formula results 13
Table B.2 Interference limits for incorrect connections 14
Table C.1 Safety marking 18
Table E.1 Applications of Small Bore Connectors 21
Table F.1 Consistency between this part and the underlying principles22
foreword
YY/T 0916 "Small Aperture Connectors for Medical Liquids and Gases", consists of the following parts.
--- Part 1.General requirements;
--- Part 2.Connections for breathing systems and driving gas applications;
--- Part 3.Connectors for gastrointestinal applications;
--- Part 5.Limb airbag inflation application connectors;
--- Part 6.Shaft application connectors;
--- Part 7.Connectors for intravascular or subcutaneous application;
--- Part 20.General test methods.
This part is Part 1 of YY/T 0916.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0916.1-2014 "Small Aperture Connectors for Medical Liquids and Gases - Part 1.General Requirements".
Compared with YY/T 0916.1-2014, the main technical changes in this part are as follows.
--- Modified normative references (see Chapter 2, Chapter 2 of the.2014 edition);
--- Modified the requirements for other small aperture connectors (see Chapter 7, Chapter 6 of the.2014 edition);
--- Modify Appendix B to verify the physical test method of non-interconnection characteristics, so as to be consistent with ISO 80369-2, ISO 80369-3,
IEC 80369-5, ISO 80369-6 and ISO 80369-7 are consistent (see Appendix B, Appendix B of the.2014 edition);
--- Added Appendix D to replace the small aperture connection proposed in Chapter 7 of the previous edition of the standard, including the new design in ISO 80369
evaluation procedures for components, and a description of computer-aided design (CAD) analysis has been added to the evaluation of non-interconnected performance (see
Appendix D, Chapter 7 of the.2014 edition).
This section uses the translation method equivalent to ISO 80369-1.2018 "Small-bore connectors for medical liquids and gases - Part 1.General
Require".
The Chinese documents that have consistent correspondence with the international documents normatively cited in this part are as follows.
---YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)
---YY/T 1474-2016 Application of Medical Device Usability Engineering to Medical Devices (IEC 62366.2007, IDT)
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section is drafted by. Shandong Medical Device Product Quality Inspection Center, Anhui Tiankang Medical Technology Co., Ltd., Zhejiang Fuer
Special Medical Equipment Co., Ltd., Henan Tuoren Medical Equipment Group Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Nudix
Asia Pharmaceutical (Wuxi) Co., Ltd., Beijing National Medical Equipment Huaguang Certification Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd., Jinan Huanzheng
Technology Development Co., Ltd.
The main drafters of this section. Yao Xiujun, Xu Hui, Bai Baodong, Su Weidong, Liu Yanhong, Gong Bingxian, Zhu Yanqin, Wang Meiying, Hong Mei, Li Yuanyu,
Fang Yuan and Li Kanyuan.
The previous versions of the standards replaced by this part are as follows.
---YY/T 0916.1-2014.
Introduction
In the.1990s, due to the large number of medical devices equipped with luer connectors as specified in ISO 80369, some
Reports of patient death or injury resulting from incorrect delivery of enteral solutions, intrathecal drugs or compressed gas due to misconnection of components have raised concerns.
worry.
The European Technical Committee for Standardization (CEN/BT) and the European Commission proposed the use of enteral nutrition circuits and gas collection and delivery systems.
Concerns with luer fittings. In November.1997, the newly created European Committee for Standardization Medical Forum Steering Group (CHeF
steeringgroup) established a Task Force (FTG) to specifically consider this issue.
FTG forms CEN's report CR13825.In this report they concluded that. in many incompatible medical applications
The use of one type of connector can create problems. In the coronary care and treatment ward, a patient uses up to 40 lubricators on multiple medical devices.
er connector. Therefore, it is not surprising that a bad connection occurs.
Appendix A "Instructions and Guidelines" of ISO 80369-1.2018 used in this part of YY/T 0916 refer to Appendix A, and Appendix B is given
For physical test methods to demonstrate non-interconnection characteristics, see Appendix C for symbols and safety markings, and Appendix D for evaluation of small-bore connectors.
Refer to Appendix E for the application of small aperture connectors, and refer to Appendix F for the basic principles.
For many years, medical devices have adhered to the principle of "safety under a single fault condition". Simply put, this means that a single failure should not generate
unacceptable risk. This principle is reflected in the requirements of many medical device standards. Introducing this principle to the luer connector
In this case, a misconnection should not pose an unacceptable risk to the patient. FTG recommends that luer connectors should be limited to use with the vascular system or
A connection between instruments to which a hypodermic syringe is attached. In addition, new small-bore connectors should be developed for applications in other fields, and these new connectors
The connector should preferably be non-interconnected with the Luer connector and various other new connectors.
ISO 16142-1 describes this type of problem in Appendix B of the Fundamental Principles (see Appendix F).
The device design scheme and medical device manufacturing adopted by the manufacturer should comply with safety principles and take into account the recognized state of the art. when
When it is necessary to reduce the risk, the manufacturer should control the risk so that the residual risk associated with each hazard (source) is judged to be acceptable. Manufacturer Yiyi
The following principles are adopted.
a) identify known or foreseeable hazards (sources) and estimate the associated risks arising from intended use and foreseeable misuse;
b) eliminate risks as far as reasonably practicable by inherently safe design and manufacture;
c) reduce residual risks as far as reasonably practicable by taking adequate safeguards, including warnings or safety messages;
d) Inform the user of all remaining risks.
The consensus is that small aperture connector systems cannot be designed to overcome all opportunities for false connections or to eliminate intentional errors
use. However, there can be multiple stages to improve the status quo and make patients safer. This is only possible through industrial, medical, medical device users and medical
The long-term efforts of the medical device management department to achieve.
As far as practicable, the ISO 80369 series of standards has limited the number of connections to one per application, unless there is a sufficient number of connections
clinical or technical evidence of the case.
It is expected that specific medical device standards will reference the interface requirements of the corresponding parts of the ISO 80369 series of standards.
This section contains general requirements to ensure the prevention of misconnection between small aperture connectors for different applications, and defines their applications.
Specifies a test method for evaluating the non-interconnecting properties of small bore connectors in the ISO 80369 series of standards.
ISO 80369-2~ISO 80369-7 specifies the dimensional requirements of the connector interface and the evaluation of the interconnectivity of the connector pair.
Basic performance requirements.
This part of ISO 80369 specifies the general requirements and tests for evaluating the non-interconnecting properties of small and medium-bore connectors in the ISO 80369 series.
method.
ISO 80369-20 specifies the test for evaluating the basic performance requirements of small bore connectors specified in ISO 80369-2~ISO 80369-7
test method.
ISO 80369-2~ISO 80369-7 specifies the interface size requirements of connectors and evaluates the interconnection between two counterparts of connectors
sexual performance requirements.
The design and dimensions of small bore connectors specified in ISO 80369-2 ~ ISO 80369-7 have been successfully completed in accordance with the requirements of this part
Rating (ie the risk of misconnection to other connections has been demonstrated to be acceptable).
Other parts of YY/T 0916 will contain requirements for connectors for different application categories.
Small Bore Connectors for Medical Liquids and Gases
Part 1.General Requirements
1 Scope
This part of YY/T 0916 specifies general requirements for small-bore connectors for transporting liquids or gases in medical applications. this
Some small bore connectors are used in medical devices or accessories intended for patient use.
This section also specifies the medical fields in which these small bore connectors are intended to be used.
These medical areas include (but are not limited to).
--- breathing system and driving gas;
--- gastrointestinal tract;
--- urinary tract;
--- Extremity airbag inflation;
--- axons; and
--- Intravascular or subcutaneous.
Based on the inherent design and dimensions of small-bore connectors, this section provides a methodology for assessing their non-interconnecting properties to ensure reduced
Incorrect connections between medical devices or accessories for different applications specified in this part and in future parts of the ISO 80369 series of standards to be developed
risks of.
This section does not specify requirements for medical devices or accessories using these small bore connectors. These requirements are specified in the medical device or attached
given in the relevant standards for the parts.
Note 1 to entry. Clause 7 allows the inclusion of the design of small bore connectors for other new applications in the ISO 80369 series of standards.
Note 2.Although the current relevant medical device-specific standards have not yet required, manufacturers are encouraged to introduce the small-bore connectors specified in this series of standards into medical devices.
equipment, medical systems or accessories. It is expected that when the relevant specific medical device standards are revised in the future, they will be considered as those specified in the ISO 80369 series of standards.
Risk of small bore connectors.
Note 3.The connectors specified in the ISO 80369 series of standards are only intended to be used in the application for which they are specified. Using these connectors in other applications increases the
increase the risk of dangerous misconnections.
Note 4.Manufacturers and responsible parties are encouraged to report their experience with small bore connectors specified in the ISO 80369 series of standards to the ISO /TC210 Secretariat for
This feedback is taken into account in the revision process of the relevant parts of the ISO 80369 series of standards.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
ISO 80369-3 Small bore connectors for medical liquids and gases - Part 3.Connectors for gastrointestinal applications (Smal-borecon-
ISO 80369-6 Small bore connectors for medical liquids and gases - Part 6.Connectors for shaft applications (Smal bore
tions)
ISO 80369-7 Small bore connectors for medical liquids and gases - Part 7.Connectors for intravascular or subcutaneous applications (Smal-bore
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