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YY/T 1842.1-2022Medical devices-Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods (English PDF)

医疗器械医用贮液容器输送系统用连接件第1部分：通用要求和通用试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2023

Scope

YY/T 1842.1-2022 is the English-translated version of 医疗器械医用贮液容器输送系统用连接件第1部分：通用要求和通用试验方法.

YY/T 1842.1-2022 is the Chinese standard "Medical devices-Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods".

Its scope clause reads: 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.

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Document preview — YY/T 1842.1-2022

National Standard of the People's Republic of China

Classification: C 30

Issued by: National Medical Products Administration of the People's Republic of China

Preface
Introduction
1 * range
2 Normative references
3 Terms and Definitions
4 Materials used for fluid reservoir connections
4.1 *General
4.2 Alternative test methods
5 *Requirements for application-specific reservoir connections
5.1 *Incompatibility of reservoir connections
5.2 Gastrointestinal applications
5.3 Neural applications
5.4 Endovascular Applications
5.5 Application of apheresis citrate anticoagulant
6 *Reservoir connections for applications not yet covered in the ISO 18250 series of standards
7 * Performance requirements
7.1 Leak
7.1.1 Positive pressure liquid leakage
7.1.2 Negative pressure air leakage
7.2 Stress cracking
7.3 Resistance to axial load separation
7.4 Anti-unscrew torque separation
7.5 Overload resistance (sliding wire)
7.6 Unscrewing separation with movable or rotatable threaded locking connections and fixed threaded locking connections
Appendix A (Informative) Instructions and Guidelines
Appendix B (normative) Test methods to demonstrate non-interconnection characteristics
Appendix C (normative) * Positive pressure liquid leakage test method
Appendix D (normative) *Negative pressure air leakage test method
Appendix E (normative) *Stress cracking test method
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
Appendix J (Informative) * Modifications to Test Methods to Obtain Measurement Data Suitable for Statistical Analysis
Appendix L (informative) Other mechanical 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) […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 43 pages — is available in the English PDF.

Referenced standards

Normative references

YY/T 0316-2016Medical devices-Application of risk management to medical devices

Cited by

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