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YY/T 0907-2023 English PDF

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YY/T 0907-2023: Needle-free injectors for medical use - Requirements and test methods
Status: Valid

YY/T 0907: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0907-2023English699 Add to Cart 5 days [Need to translate] Needle-free injectors for medical use - Requirements and test methods Valid YY/T 0907-2023
YY/T 0907-2013English1239 Add to Cart 3 days [Need to translate] Needle-free injectors for medical use. Requirements and test methods Obsolete YY/T 0907-2013

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Basic data

Standard ID YY/T 0907-2023 (YY/T0907-2023)
Description (Translated English) Needle-free injectors for medical use - Requirements and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 34,344
Date of Issue 2023-06-20
Date of Implementation 2024-07-01
Older Standard (superseded by this standard) YY/T 0907-2013
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements and test methods for single- or multiple-use medical needle-free syringes (hereinafter referred to as needle-free syringes) used in clinical and related medical environments or for personal use. This standard applies to single- or multiple-use needle-free syringes intended for use in clinical and related medical settings or for personal use. This standard does not apply to the following drug delivery methods of needle-free injectors: the puncture of a part of the needle-free injection device itself enters or penetrates the skin or mucous membrane (such as needles, tips, microneedles, implantable slow-release drug devices); Generation of aerosols, droplets, powders or other forms for inhalation, insufflation, nasal or oral deposition (e.g. spray, inhaler, nebuliser); passive diffusion of liquid, powder or other substances deposited on skin or mucous membrane surfaces or ingestion (e.g. transdermal absorption)

YY/T 0907-2023: Needle-free injectors for medical use - Requirements and test methods

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ICS 11.040.20 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0907-2013 Requirements and test methods for medical needleless syringes (ISO 21649.2006,MOD) Published on 2023-06-20 2024-07-01 Implementation Released by the State Drug Administration

Table of contents

Preface III 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 3 4 Symbols and abbreviations 4 5 Requirements 5 5.1 General requirements 5 5.2 Noise requirements 6 5.3 Dosage specification requirements 6 5.4 Measurement Uncertainty and Specification Conformity6 5.5 Performance requirements 6 5.6 Test requirements 7 6 Test methods 9 6.1 Summary 9 6.2 Test procedure 10 6.3 Test conditions 16 6.4 Test evaluation16 7 Information provided by the manufacturer18 7.1 Overview 18 7.2 Identification 18 7.3 User Manual 18 Appendix A (Informative) Design and Materials Guidance 20 Appendix B (Normative) Extraction solution preparation and test methods 21 Appendix C (Normative) Two-sided tolerance (k) 22 Appendix D (informative) Accuracy limit calculation and random setting examples 28 Reference 29

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY/T 0907-2013 "Requirements and Test Methods for Medical Needleless Syringes". Compared with YY/T 0907-2013, In addition to editorial changes, the main technical changes are as follows. a) Added requirements for adaptability of needleless syringe components (see 5.5.4); b) Added chemical requirements for needleless syringes (see 5.5.5); c) Added biological requirements (see 5.5.6); d) Added test procedures (see 6.2); e) Added instructions for use of needleless syringes and unit packaging labeling requirements (see 7.3); f) Added extraction solution preparation and test methods (see Appendix C). This document is modified to adopt ISO 21649.2006 "Requirements and Test Methods for Medical Needleless Syringes" The technical differences and reasons between this document and ISO 21649.2006 are as follows. ---Replaced IEC 60068-2-30.2005 (see 6.3) with the normatively cited GB/T 2423.4 to adapt to my country's technical conditions, Improve operability; ---Replaced IEC 60068-2-27.1987 (see 6.2.7) with the normatively quoted GB/T 2423.5 to adapt to my country's technical conditions parts to improve operability; ---Replaced IEC 60068-2-64.1993 (see 6.2.7) with the normatively cited GB/T 2423.56 to adapt to my country's technical requirements parts to improve operability; ---Replaced ISO 3746.1995 (see 6.2.9) with normatively cited GB/T 3768 to adapt to my country's technical conditions and improve Operability; ---Replaced ISO 10993 (all parts) with normatively cited GB/T 16886 to adapt to my country's technical conditions and improve reliability operability; ---Replaced ISO 11201.1995 (see 6.2.9) with normatively cited GB/T 17248.2 to adapt to my country's technical conditions, Improve operability; ---Replaced ISO 11202.1995 (see 6.2.9) with normatively cited GB/T 17248.3 to adapt to my country's technical conditions, Improve operability; ---Replaced ISO 11204.1995 (see 6.2.9) with normatively cited GB/T 17248.5 to adapt to my country's technical conditions, Improve operability; ---Replaced ISO 14253-1.1998 (see 5.4) with GB/T 18779.1-2022, which is equivalent to the international standard, to adapt to our country technical conditions to improve operability; ---Replaced IEC 60601-1-1.2000 (see 5.1) with normatively quoted GB 9706.1 to adapt to my country's technical conditions and improve High operability; ---Added normative references to GB/T 14233.1-2008 and GB/T 14233.2 (see 6.2), and added corresponding chemical test methods method to adapt to my country’s technical conditions; ---Added adaptability requirements for needleless syringe components; ---Added chemical requirements, biological requirements and testing procedures for needle-free syringes; ---Added needleless syringe instruction manual and unit packaging labeling requirements; ---Deleted the requirements for clinical trials in 5.5.3; ---Added Appendix C "Extraction solution preparation and test methods". The following editorial changes have been made to this document. ---Deleted the note on regulatory content in 5.5.4; ---Informative Appendix D "Guidelines for Design and Materials" has been added; ---Deleted the informative Appendix C "Contrast between ISO /IEC standards and EN standards"; ---Deleted the informative Appendix D "The relationship between this standard and the essential requirements of EU Directive 93/42/eec". Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC95). This document was drafted by. Beijing Kuaishuer Medical Technology Co., Ltd., Shanghai Institute of Medical Device Inspection, Jiangxi Sanxin Medical Technology Co., Ltd. The main drafters of this document. Qi Xin, Lu Liyuan, Hua Songhe, Wang Dan, and Wang Ganying. The previous versions of this document and the documents it replaces are as follows. ---First released in.2013 as YY/T 0907-2013; ---This is the first revision. Requirements and test methods for medical needleless syringes

1 Scope

This document specifies medical needleless syringes for single or multiple use for use in clinical and related medical settings or for personal use. (hereinafter referred to as "needleless syringe") requirements and test methods. This document applies to single- or multiple-use needleless syringes for use in clinical and allied health care settings or for personal use. Note. The medication chamber of a needleless syringe is usually disposable and must be replaced after a single use or a limited number of uses. Sometimes it is separated from the injection mechanism Isolated, and often referred to as "cartridge", "ampule", "syringe", "capsule" or "disc". On the contrary, the medicine chamber can also be a permanent inner chamber, and its usability Can remain valid within the validity period. This document does not apply to the following administration methods using needleless syringes. ---Puncture a part of the needleless injection device itself into or penetrate the skin or mucous membrane (such as needle, tip, microneedle, implantable slow drug release device); ---Produces aerosols, droplets, powders or other forms for inhalation, insufflation, nasal or oral deposition (such as sprays, inhalers, atomization device); ---The deposited liquid, powder or other substances on the surface of the skin or mucous membranes are passively diffused or ingested by the body (such as transdermal absorption patches, liquid drop); ---Applied to acoustic energy or electromagnetic energy (such as ultrasound or ion introduction device); ---Infusion system, which uses artificial pipes, catheters and/or needles inserted into the human body to add or measure drugs.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the documents. Among them, dated references For documents, only the version corresponding to the date applies to this document; for undated referenced documents, the latest version (including all modification orders) applies in this document. GB/T 2423.4 Environmental testing of electrical and electronic products Part 2.Test methods Test Db. Alternating damp heat (12h 12h cycle Ring) (GB/T 2423.4-2008, IEC 60068-2-30.2005, IDT) GB/T 2423.5 Environmental testing Part 2.Test method Test Ea and guidance. Impact (GB/T 2423.5-2019, IEC 60068-2-27.2008,IDT) GB/T 2423.7-2018 Environmental testing Part 2.Test methods Test Ec. Impact caused by rough operation (mainly used for Equipment type sample)(IEC 60068-2-32.2008,IDT) GB/T 2423.56 Environmental testing Part 2.Test method test Fh; Broadband random vibration and guidelines (GB/T 2423.56- 2018,IEC 60068-2-64.2008,IDT) GB/T 3768-2017 Acoustic sound pressure method determines the sound power level and sound energy level of noise sources using the envelope measurement surface above the reflective surface Simple method (ISO 3746.2010, IDT) GB/T 3785.1-2010 Electroacoustic sound level meter Part 1.Specification (IEC 61672-1.2002, IDT) GB/T 4798.7-2007 Application environmental conditions for electrical and electronic products Part 7.Portable and non-stationary use (IEC 60721-3-7. 2002,MOD) Note. There is no technical difference between the quoted content of GB/T 4798.7-2007 and the quoted content of IEC 60721-3-7.2002. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020, IEC 60601-1.2012, MOD)

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