YY/T 1842.1-2022_English: PDF (YY/T1842.1-2022)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 1842.1-2022 | English | 894 |
Add to Cart
|
5 days [Need to translate]
|
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods
| Valid |
YY/T 1842.1-2022
|
Standard ID | YY/T 1842.1-2022 (YY/T1842.1-2022) | Description (Translated English) | Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | IDT-GB168 | Word Count Estimation | 49,493 | Date of Issue | 2022-05-18 | Date of Implementation | 2023-06-01 | Drafting Organization | Shandong Medical Device Product Quality Inspection Center, Anhui Tiankang Medical Technology Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd., Jinan Huanzheng Technology Development Co., Ltd., Nutricia Pharmaceutical (Wuxi) Co., Ltd., Beijing National Medical Equipment Huaguang Certification Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Zhejiang Volt Medical Equipment Co., Ltd., Henan Tuoren Medical Equipment Group Co., Ltd. | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC 106) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies general requirements for connections for fluid reservoir delivery systems in medical applications. These reservoir connections are used in medical devices or accessories intended for use with patients. This standard also specifies the medical fields in which these reservoir connections are intended to be used. These medical areas include, but are not limited to, the following applications: Respiratory; Gastrointestinal; Neurological; Endovascular; Citrate Anticoagulants, and Irrigation. Unless otherwise specified in the YY/T 1842 series, the liquid storage container connections specified in this standard are not interconnected with the following: Liquid storage container connections for all other applications specified in the YY/T 1842 series; ISO 80601-2- 74 |
YY/T 1842.1-2022
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1.General requirements and common test methods
ICS 11.040.25
CCSC30
People's Republic of China Pharmaceutical Industry Standard
Medical device medical liquid storage container delivery system
used connectors part 1. general requirements and
General Test Methods
(ISO 18250-1.2018, IDT)
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 * range 1
2 Normative references 1
3 Terms and Definitions 2
4 Materials used for fluid reservoir connections3
4.1 *General 3
4.2 Alternative test methods 3
5 *Requirements for application-specific reservoir connections4
5.1 *Incompatibility of reservoir connections 4
5.2 Gastrointestinal applications 4
5.3 Neural applications 4
5.4 Endovascular Applications 4
5.5 Application of apheresis citrate anticoagulant 4
6 *Reservoir connections for applications not yet covered in the ISO 18250 series of standards4
7 * Performance requirements 5
7.1 Leak 5
7.1.1 Positive pressure liquid leakage 5
7.1.2 Negative pressure air leakage 5
7.2 Stress cracking 5
7.3 Resistance to axial load separation 5
7.4 Anti-unscrew torque separation 5
7.5 Overload resistance (sliding wire) 5
7.6 Unscrewing separation with movable or rotatable threaded locking connections and fixed threaded locking connections 5
Appendix A (Informative) Instructions and Guidelines 6
Appendix B (normative) Test methods to demonstrate non-interconnection characteristics 12
Appendix C (normative) * Positive pressure liquid leakage test method 24
Appendix D (normative) *Negative pressure air leakage test method 26
Appendix E (normative) *Stress cracking test method 29
Appendix F (normative) *Test Method 31 for Resistance to Axial Load Separation
Appendix G (normative) *Test Method 33 for Torque Separation Resistance
Appendix H (normative) *Anti-Overload (Sliding Wire) Test Method 35
Annex I (normative) * Unscrewing separation test with movable or rotatable threaded locking connections and fixed threaded locking connections
Method 37
Appendix J (Informative) * Modifications to Test Methods to Obtain Measurement Data Suitable for Statistical Analysis39
Appendix K (informative) Examples of medical devices that may be used for liquid containers in each application category 41
Appendix L (informative) Other mechanical test methods 42
Reference 43
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 1 of YY/T 1842 "Connectors for Medical Devices and Medical Fluid Storage Container Delivery Systems". YY/T 1842 has
The following sections have been published.
--- Part 1.General requirements and general test methods;
--- Part 8.Application of apheresis citrate anticoagulant.
This document uses the translation method identically to ISO 18250-1.2018 "Connectors for Medical Device Liquid Storage Container Delivery Systems No.
Part 1.General requirements and general test methods".
The Chinese documents that have a consistent correspondence with the international documents normatively cited in this document are as follows.
---GB/T 1040.1-2018 Determination of Tensile Properties of Plastics Part 1.General (ISO 527-1.2012, IDT)
---GB/T 1040.2-2006 Determination of Tensile Properties of Plastics Part 2.Test Conditions for Molded and Extruded Plastics
(ISO 527-2.1993, IDT)
---GB/T 9341-2008 Determination of flexural properties of plastics (ISO 178.2001, 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 agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC106).
This document was drafted by. Shandong Medical Device Product Quality Inspection Center, Anhui Tiankang Medical Technology Co., Ltd., Fresenius
Kabi (China) Investment Co., Ltd., Jinan Huanzheng Technology Development Co., Ltd., Nutricia Pharmaceuticals (Wuxi) Co., Ltd., Beijing Guoyi Machinery Co., Ltd.
Light Certification Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Zhejiang Volt Medical Equipment Co., Ltd., Henan Camel Medical
Equipment Group Co., Ltd.
The main drafters of this document. Zhang Limei, Wang Changbin, Zhou Yuyan, Hong Mei, Fang Yuan, Zhu Yanqin, Wang Meiying, Li Songhua, Su Weidong, Liu Yanhong,
Bai Baodong and Ai Chongchong.
introduction
During the development of the ISO 80369 series of small bore connector standards, it became clear that the connection between medical devices and reservoirs became the same.
just as important. It was agreed that such connectors should be developed in parallel with the small bore connectors specified in the ISO 80369 series of standards and comply with similar
security and interoperability requirements.
Clause 4 of ISO 16142-1.2016 addresses this type of problem.
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 should press
The following sequence is used in order.
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 is reasonably practicable by taking adequate protective measures, including warnings or safety messages;
d) Inform the user of all remaining risks.
It was quickly realized that many reservoirs containing fluids for different applications administered to patients used the ubiquitous trocar.
Acts as a connection between the drug delivery device and the reservoir, resulting in incorrect drug administration. The ISO 18250 series is dedicated to each
The application offers a unique design to reduce the risk of wrong dosing. It should be understood that reservoir connection system design cannot overcome all errors.
the possibility of misconnection, nor does it eliminate intentional misuse. However, there are steps that can be taken to improve the status quo and make patients safer. This can only
This is achieved through the long-term efforts of industry, medical professionals, medical device purchasers and medical device regulators.
YY/T 1842 "Connectors for Medical Liquid Storage Container Delivery Systems for Medical Devices" is intended to consist of the following parts.
--- Part 1.General requirements and general test methods. The purpose is to specify connections for liquid reservoir delivery systems in medical applications
General requirements for items.
--- Part 3.Gastrointestinal applications. The purpose is to specify the dimensions, as well as design and functional characteristics of reservoir connections for gastrointestinal applications
requirements.
--- Part 6.Neural applications. The purpose is to specify the connection between the outlet end of the nerve reservoir and the inlet end of the nerve delivery device.
Require.
--- Part 7.Connectors for intravascular infusion. The purpose is to specify the connection between the intravascular infusion set and the intravascular infusion reservoir container.
dimensions, as well as design and functional characteristics requirements.
--- Part 8.Application of apheresis citrate anticoagulant. The purpose is to specify the dimensions of the connections of the apheresis anticoagulant reservoirs, and the design of the
requirements for design and functional characteristics.
The ISO 18250 series specifies requirements to prevent misconnections between reservoir connections used in different applications. This document stipulates
General requirements and general test methods for all reservoir connections in this series are described. Specific test methods for specific reservoir connections will be
Included in this application section. The ISO 18250 series specifies the prevention of incorrect connections between reservoir connections used in different applications
or reduce its incidence to acceptable levels.
Although not required by the current relevant specific medical device standards, manufacturers are encouraged to use the liquid storage containers specified in the YY/T 1842 series
Connectors are incorporated into medical devices, medical systems or accessories. It is expected that when the relevant specific medical device standards are revised, they will be included in this series of standards
Requirements for specified reservoir connections.
YY/T 1842 series is not suitable for screw caps, crown caps and screw mouths, because they are not special connectors for medical devices.
Note. Examples of threaded caps and threads are defined in DIN55525, ASTMD2911/D2911M, DIN6063-1, DIN6063-2, DIN168-1.Emperor
Examples of crown caps are defined in DIN6094, ISO 12821, EN14635.
If there is an asterisk (*) at the beginning of a title, paragraph or table title, relevant instructions and guidelines are given in Appendix A.
Medical device medical liquid storage container delivery system
used connectors part 1. general requirements and
General Test Methods
1 Scope
This document specifies the general requirements for connections for reservoir delivery systems in medical applications. These reservoir connections are used for
In a medical device or accessory intended for use on a patient.
This document also specifies the medical fields in which these reservoir connections are intended to be used.
These medical areas include (but are not limited to) the following applications.
--- respiratory system;
--- gastrointestinal tract;
---nerve;
--- intravascular;
--- citrate anticoagulants; and
---rinse.
Unless otherwise specified in the YY/T 1842 series, the liquid storage container connections specified in this document are not interconnected with the following.
--- YY/T 1842 series for all other applications of liquid storage container connections;
--- ISO 80601-2-74.2017 Detachable temperature sensor port specified in Annex EE;
--- ISO 172561) Threaded connections specified in Appendix B.
1) Under development, currently ISO /DIS17256.2017.
The applied part of the YY/T 1842 series may specify other non-interconnected connection parts (specified in the applied part) of the liquid storage container.
connector.
This document specifies a methodology for assessing the non-interconnecting properties of liquid storage container connections based on their inherent design and dimensions.
This document does not specify requirements for medical devices or accessories using these reservoir connections, which are
given in the relevant standards for the parts.
This document also specifies test methods for verifying the general performance requirements for connections to liquid containers. Performance requirements for these general test methods
Specified in the application section, not in the general section.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)
ties-Part 1.Generalprinciples)
......
|