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YY 0451-2023 PDF English (YY 0451-2010: Older version)Search result: YY 0451-2023 (YY 0451-2010 Older version)
YY0451-2023: PDF in EnglishYY 0451-2023 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.01 CCS C 47 Replacing YY 0451-2010 Portable Infusion Devices for Single Use - Non Electrically Driven (ISO 28620:2020, Medical Devices - Non-electrically Driven Portable Infusion Devices, MOD) ISSUED ON: SEPTEMBER 5, 2023 IMPLEMENTED ON: SEPTEMBER 15, 2026 Issued by: National Medical Products Administration Table of Contents Foreword ... 3 Introduction ... 5 1 Scope ... 6 2 Normative References ... 6 3 Terms and Definitions ... 7 4 General Requirements ... 9 5 Operating Requirements ... 12 6 Test Methods ... 12 7 Information That Shall Be on the Packaging and / or Product ... 17 8 Accompanying Documents ... 18 Appendix A (informative) Technical Differences between This Document and ISO 28620:2020, and Causes for the Differences ... 19 Appendix B (normative) Particulate Pollution Test ... 22 Bibliography ... 25 Portable Infusion Devices for Single Use - Non Electrically Driven 1 Scope This document specifies the basic requirements and corresponding test methods for portable infusion devices for single use - non electrically driven (hereinafter referred to as the infusion devices). This document is applicable to infusion devices for continuous (fixed or adjustable) and / or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications. NOTE: the parts of neurological application include the spine, intrathecal or subarachnoid space, ventricles, epidural space, epidural space or dural space. Neurological anesthetics can be locally infused to affect large parts (for example, limbs) of the body and involve nerve plexus blocks (for example, brachial plexus block or single nerve block). The neurological application procedure involves a continuous infusion of local anesthetic into the wound. This document does not apply to: ---Electrically driven or electrically controlled infusion devices covered by GB 9706.224; ---Devices for the delivery of discrete (bolus) medicinal liquids covered by the YY/T 1768 series for use by a single patient; ---Implanted devices; ---Enteral feeding pumps; ---Transcutaneous infusion devices; ---Devices whose infusion is not driven by the devices themselves or devices whose infusion is driven by active intervention by the patient (for example, devices powered solely by gravity). 2 Normative References The contents of the following documents constitute indispensable clauses of this document through normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T 6682- 2008, ISO 3696:1987, MOD) GB 8368 Infusion Sets for Single Use - Gravity Feed (GB 8368-2018, ISO 8536-4:2010, MOD) GB/T 14233.1-2022 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (GB/T 16886.1-2022, ISO 10993-1:2018, IDT) YY 0286.1-2019 Infusion Sets for Special Purpose - Part 1: Infusion Sets for Single Use with Micropore Filters YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT) YY/T 0916.1 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: General Requirements (YY/T 0916.1-2021, ISO 80369-1:2018, IDT) YY/T 0916.6 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 6: Connectors for Neuraxial Applications (YY/T 0916.6-2022, ISO 80369-6:2016, IDT) ISO 80369-7 Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 7: Connectors for Intravascular or Hypodermic Applications1) 3 Terms and Definitions The following terms and definitions are applicable to this document. 3.1 bolus Input a certain volume of medicinal fluid in a short time. 3.2 bolus refill time The time required to refill an empty bolus device to the bolus volume. 3.3 nominal bolus refill time The bolus refill time (3.2) marked on the infusion device or its packaging. 3.4 filling volume The nominal volume (3.10) plus the residual volume (3.5). 3.5 residual volume After the infusion is completed, the volume of residual fluid in the infusion device and its 1) YY/T 0916.7, which equivalently adopts ISO 80369-7:2021, is about to be issued. 4 General Requirements 4.1 Composition The infusion device shall include the following components: ---Non-electrical energy-driven component for the infusion of medicinal fluids; ---Flow-limiting device; ---Liquid storage bag used to hold infused medicinal fluids; ---Medicinal fluid filter on the medicinal liquid infusion channel. NOTE 1: these components are either integral or separated. The infusion device may also include one or more of the following components (non-exhaustive list): ---Flow regulating system; ---Liquid filling port, preferably equipped with an anti-backflow valve; NOTE 2: the liquid filling port is only used for filling medicinal fluids and shall comply with the female Luer connectors in YY/T 0916.7. ---The end of the pipeline complies with the locking connectors in YY/T 0916.6 or YY/T 0916.7, so as to satisfy the requirements for the intended use; ---Flow-stop clamp, if necessary; ---Sterile protective sleeves, for example, Luer caps, on the end of the pipeline and the filling port; ---An infusion system that performs bolus within the infusion time range in a mode of controlling the maximum infusion volume; ---Protective device for the liquid storage bag, so as to prevent the medicinal liquids from flowing out when the liquid storage bag ruptures or leaks (shall satisfy the leakage test of 6.5 and 6.6); ---The mode, in which, the end point of infusion is indicated; NOTE 3: achieved through visual, auditory or other prompts. ---Infusion pipeline; ---Exhaust device. 4.2 Materials The materials used in parts that come into contact with medicinal liquids shall undergo biological evaluation in accordance with the relevant parts of GB/T 16886.1. 4.3 Design and Characteristics 4.3.1 General principle The infusion device shall be designed to deliver in accordance with the nominal flow rate (5.1). 4.3.2 Connectors If applicable, the connectors of the liquid filling port shall comply with the female locking connectors in YY/T 0916.6 or YY/T 0916.7. If connectors are used at the end of the pipeline, they shall comply with the male locking connectors in YY/T 0916.6 or YY/T 0916.7, so as to satisfy the requirements for the intended use. All connectors on the infusion device used to connect to other medical devices or accessories shall be designed in accordance with YY/T 0916.1, YY/T 0916.6 or YY/T 0916.7, so as to satisfy the requirements for the intended use. NOTE: YY/T 0916.6 and YY/T 0916.7 specify the materials, dimensional design and performance requirements for the connectors. On the premise that the materials and designed dimensions of the connectors satisfy the corresponding standards, the connectors are generally considered to comply with the requirements for non-interconnection characteristics in YY/T 0916.1, then, they will only be tested in accordance with the performance requirements in YY/T 0916.6 or YY/T 0916.7. 4.3.3 Filters The system liquid path shall be equipped with a filter with a nominal bore less than or equal to 5 m and shall comply with the requirements for particulate pollution and filtration performance of medicinal liquids in YY 0286.1-2019. 4.3.4 Pipeline The infusion devices may be designed so that their pipeline is integral or separated. If the pipeline is separated, the system connected to the infusion devices shall use locking connectors. When tested in accordance with 6.4, the connection between the liquid storage bag and the pipeline shall be able to withstand a static tensile force of 15 N for 15 seconds. 4.3.5 Liquid storage bag All components on the infusion devices that come into contact with the medicinal liquids shall constitute a closed and leak-free system. This requirement can be verified by the test methods 4.5.5 Evaporation residue Test in accordance with the method of 5.5 in GB/T 14233.1-2022. The total amount of evaporation residue shall not exceed 2 mg. 4.5.6 UV absorbance In accordance with the stipulations of 5.7 in GB/T 14233.1-2022, within 220 nm ~ 360 nm, carry out the test, and the absorbance of the test solution shall not be greater than 0.3. 4.5.7 Residue of ethylene oxide When cutting a sample from the liquid storage bag and testing in accordance with Chapter 9 in GB/T 14233.1-2022, the residue of ethylene oxide shall not exceed 10 g/g. 5 Operating Requirements 5.1 Flow Rate The nominal flow rate of the infusion device shall be calibrated with a quality control solution at a given temperature. The nominal flow rate and the quality control solution and this temperature shall be specified in the instructions for use accompanying the infusion device [see 8c] and 8g)]. When tested in accordance with 6.2, the average flow rate shall be within the 15% deviation range of the nominal flow rate, and the adjustable flow rate shall be within the 20% deviation range of the nominal flow rate. The instantaneous flow rate of at least 80% of the nominal volume shall be supplied within 50% deviation range of the nominal flow rate. NOTE: if the infusion device is exposed to external pressure, the instantaneous flow rate may deviate by more than 50% of the nominal flow rate. 5.2 Bolus (if applicabl.......Source: https://www.ChineseStandard.net/PDF.aspx/YY0451-2023 |