Search result: YY/T 1842.3-2023
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Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications
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YY/T 1842.3-2023
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| Standard ID | YY/T 1842.3-2023 (YY/T1842.3-2023) | | Description (Translated English) | Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 42,415 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2024-12-01 | | Drafting Organization | Shandong Medical Device and Drug Packaging Inspection Institute, Nutricia Pharmaceuticals (Wuxi) Co., Ltd., Anhui Tiankang Medical Technology Co., Ltd., Shandong Ande Medical Supplies Co., Ltd., Beijing Guoyi Huaguang Certification Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Equipment (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies requirements for the dimensions, design and functional characteristics of connectors intended for use in gastrointestinal fluid storage containers. This standard does not specify dimensional or performance requirements for medical devices or accessories using these connectors. These requirements are given in the standard for the specific medical device or accessory. This standard does not apply to threaded caps, crown caps, and threaded connections because they are not dedicated connectors for medical devices. Although gastrointestinal feeders often need to be connected to them, they are more suitable for the field of food and beverage packaging. |
YY/T 1842.3-2023.Medical devices - Connectors for liquid storage containers and delivery systems - Part 3.Gastrointestinal applications
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Medical equipment and liquid storage container transportation
System connectors
Part 3.Gastrointestinal applications
(ISO 18250-3.2018,IDT)
Released on 2023-11-22
2024-12-01 implementation
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 2
4.1 Non-interconnected features 2
4.2 Material requirements 2
5 Size requirements 2
6 Performance requirements 3
6.1 General performance requirements 3
6.2 Positive pressure liquid leakage 3
6.3 Negative pressure air leakage 3
6.4 Stress cracking 3
6.5 Resistance to axial load separation 3
6.6 Anti-unscrewing torque separation 3
6.7 Overload resistance (slippage) 4
6.8 Unscrew and separate 4
Appendix A (Informative) Notes and Guidelines 5
A.1 General 5
A.2 Explanation of specific clauses and sub-clauses 5
Appendix B (Normative) Gastrointestinal reservoir connector 6
Appendix C (Normative) Standard Connectors 17
C.1 General requirements for standard connectors 17
C.2 Standard connectors 17
Appendix D (informative) Evaluation of medical devices with connections for this application and their properties 23
Appendix E (Informative) Summary of usability requirements for gastrointestinal reservoir connections 24
E.1 User Features 24
E.2 Usage scenarios 24
E.3 Usage Environment 25
E.4 Other attributes 26
E.5 General user requirements 26
Appendix F (Informative) Summary of criteria and requirements for gastrointestinal reservoir connectors 27
Appendix G (Informative) Summary of Design Evaluation of Reservoir Connections for Gastrointestinal Applications 30
G.1 General Principles 30
G.2 Design Engineering Analysis Overview 30
G.3 Design Verification Summary 32
G.4 Design Verification Summary 32
G.5 Design Review Summary 32
Appendix H (Informative) Differences from YY/T 0916.20 33
Appendix I (informative) Geometric design and function of twist-lock connectors 34
Reference 36
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is Part 3 of YY/T 1842 "Connectors for medical device liquid storage container delivery systems".
The following parts have been published.
--- Part 1.General requirements and general test methods;
--- Part 3.Gastrointestinal application;
--- Part 6.Neurological applications;
--- Part 7.Connectors for intravascular infusion;
--- Part 8.Application of citrate anticoagulants in single collection.
This document is equivalent to ISO 18250-3.2018 "Medical devices - Connectors for medical fluid containers and delivery systems - Part 3.Gastrointestinal
Dao Application.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Nutricia Pharmaceuticals (Wuxi) Co., Ltd., Anhui Tian
Kang Medical Technology Co., Ltd., Shandong Ande Medical Supplies Co., Ltd., and Beijing Guoyixie Huaguang Certification Co., Ltd.
The main drafters of this document are. Wang Changbin, Zhu Yanqin, Zhou Yuyan, Wang Yongbing, Yu Kelong, Wang Meiying and Li Kanyuan.
introduction
During the development of ISO 80369-3.2016, a standard for small-aperture gastrointestinal connectors, it was discovered that the risk of incorrect connection is not limited to
This risk also needs to be considered for the connections to the patient and the entire gastrointestinal system.
However, gastrointestinal fluid container connectors do not fully meet the definition of small-bore connectors, so
It was decided to develop a separate standard for this type of connector to take into account the risk of incorrect connection between it and other devices such as IV bags.
To reflect current use of feed fluid reservoirs, this document includes two different designs of connectors.
YY/T 1842 "Connectors for medical device liquid storage container delivery systems" is intended to consist of the following parts.
--- Part 1.General requirements and general test methods;
--- Part 3.Gastrointestinal application;
--- Part 6.Neurological applications;
--- Part 7.Connectors for intravascular infusion;
--- Part 8.Application of citrate anticoagulants in single collection.
Medical equipment and liquid storage container transportation
System connectors
Part 3.Gastrointestinal applications
1 Scope
This document specifies requirements for the dimensions and design and functional characteristics of connections intended for use on gastrointestinal fluid storage containers.
This document does not specify dimensional or performance requirements for medical devices or accessories that use these connectors. These requirements are specified in the specific medical device
or given in the standard of the appendix.
NOTE 1 Even if specific medical device standards do not currently require it, manufacturers are encouraged to incorporate connectors specified in this document into medical devices for the gastrointestinal tract.
It is expected that the requirements for liquid container connections specified in ISO 18250 will be included when the dedicated medical device standard is revised.
This document does not apply to threaded caps, crown caps, and screw caps, as they are not intended for medical device connections.
Devices often need to be connected to them, but they are more suitable for the field of food and beverage packaging.
Note 2.Examples of threaded caps and screw threads are given in DIN 55525.1988, ASTM D 2911-94 (2001 review), DIN 6063-1.2004, DIN 6063-2.2004,
Defined in DIN168-1.1998; examples of crown caps are defined in DIN6094-1.1998, ISO 12821.2003, EN14635.2010.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
YY/T 0916.20-2019 Small-bore connectors for medical liquids and gases Part 20.General test methods (ISO 80369-
20.2015,IDT)
ISO 18250-1 Medical devices - Connectors for use in medical fluid containers and delivery systems - Part 1.General requirements and general test methods
Note. YY/T 1842.1-2022 Medical devices Medical liquid storage container delivery system connector Part 1.General requirements and general test methods
(ISO 18250-1.2018, IDT)
plastics
ASTM D790-10 Standard test method for flexural properties of unreinforced and reinforced plastics and electrical insulating materials
tingmaterials
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in ISO 18250-1 and the following apply.
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