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YY 0451-2023 related PDF English

YY 0451-2023 (YY0451-2023) & related versions
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusSimilar PDF
YY 0451-2023English359 Add to Cart 4 days Portable infusion devices for single use - Non electrically driven YY 0451-2023 Valid YY 0451-2023
YY 0451-2010English150 Add to Cart 0-9 seconds. Auto delivery. Portable infusion devices for single use - Non electrically driven YY 0451-2010 Valid YY 0451-2010
YY 0451-2003English679 Add to Cart 5 days Single-use injectors for continuous ambulatory administration of medicinal products by parenteral route YY 0451-2003 Obsolete YY 0451-2003



YY 0451-2023: PDF in English
YY 0451-2023. Disposable portable infusion pumps with non-electric drive
ICS 11.080.01
CCSC47
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0451-2010
Single use portable infusion pump non-electrically driven
devices,MOD)
Published on 2023-09-05
Implemented on 2026-09-15
Released by the State Drug Administration
Preface
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 0451-2010 "Disposable Portable Infusion Pump Non-Electric Drive". Compared with YY 0451-2010, except for the
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
---Changed the scope (see Chapter 1, Chapter 1 of the.2010 edition);
---Changed the composition (see 4.1,.2010 version of 4.1);
---Changed the material (see 4.2,.2010 version of 4.2);
---Changed the general principles of design and characteristics (see 4.3.1, 4.3.1 of the.2010 version);
---Changed the connectors in design and characteristics (see 4.3.2,.2010 version of 4.3.2);
---Changed the filter in design and characteristics (see 4.3.3,.2010 version of 4.3.3);
---Changed the pressure resistance test (see 6.3,.2010 version of 6.3);
---Changed the tensile strength test (see 6.4, 6.6 of the.2010 edition);
---Changed the drop test (see 6.5, 6.4 of the.2010 version).
---Changed the information that should be on the packaging and/or product (see Chapter 7, Chapter 7 of the.2010 edition).
This document is modified to adopt ISO 28620.2020 "Medical Devices Non-electrically Driven Portable Infusion Pumps".
Compared with ISO 28620.2020, this document has made the following structural adjustments.
---Increased particulate pollution (see 4.3.6);
---Increased chemical properties (see 4.5).
Compared with ISO 28620.2020, this document has many adjustments in structure. Appendix A lists the corresponding technical differences and their reasons.
List.
This document also has the following editorial changes.
---Added Appendix A (informative) "Technical differences and reasons between this document and ISO 28620.2020".
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 Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
Previous versions of this document and the documents it replaces.
---First released as YY 0451-2003 in.2003, first revised in.2010;
---This is the second revision.
introduction
Single-use portable infusion pumps are non-electrically driven and can be used in both healthcare and non-healthcare settings. They can be operated by healthcare professionals.
personnel or intended patient use or administration.
Currently domestic infusion pumps are typically filled by a healthcare professional before use. The existence of foreign infusion pumps is pre-specified by the manufacturer (pharmaceutical factory)
In the case of filling medicinal liquid, the manufacturer (pharmaceutical factory) is required to provide research conclusions on the compatibility/stability of the device and specific drugs. This document does not cover
related information.
In order to facilitate clinical selection of an appropriate type of infusion pump, it is recommended that manufacturers mark the public label used at the end of the pipeline on the product packaging or accompanying documents.
The type of locking connector is convenient for medical staff to choose.
Single use portable infusion pump non-electrically driven
1 Scope
This document specifies the basic requirements and corresponding tests for single-use portable infusion pumps - non-electrically driven (hereinafter referred to as infusion pumps)
method.
This document applies to infusion pumps for continuous (fixed or adjustable) and/or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications.
Note. The sites of neurological application include the spine, intrathecal or subarachnoid space, ventricles, epidural space, epidural space or dural space. Neurological anesthetics
Can be infused locally to affect large parts of the body (e.g. limbs) and involve plexus blockade (e.g. brachial plexus block or single nerve block). nerve
The application process involves a continuous infusion of local anesthetic into the wound.
This document does not apply to.
---Electric or electronically controlled infusion pumps 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;
---Implantation devices;
---Intestinal feeding pump;
---Transcutaneous infusion device;
---Infusion power is not provided by the device itself or is powered by the patient's active intervention (for example, a device powered only by gravity)
device).
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696.1987, MOD)
GB 8368 Disposable infusion set gravity infusion type (GB 8368-2018, ISO 8536-4.2010, MOD)
GB/T 14233.1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process (GB/T 16886.1-
2022,ISO 10993-1.2018,IDT)
YY 0286.1-2019 Special infusion set Part 1.Disposable microporous filter infusion set
YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General requirements
(YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 0916.1 Small bore connectors for medical liquids and gases Part 1.General requirements (YY/T 0916.1-2021,
ISO 80369-1.2018,IDT)
YY/T 0916.6 Small-bore connectors for medical liquids and gases Part 6.Axial application connectors (YY/T 0916.6-
2022,ISO 80369-6.2016,IDT)
ISO 80369-7 Small bore connectors for medical liquids and gases Part 7.Connectors for intravascular or subcutaneous applications 1) (Smal-
1) YY/T 0916.7 will be released soon, which is equivalent to ISO 80369-7.2021.
......

BASIC DATA
Standard ID YY 0451-2023 (YY0451-2023)
Description (Translated English) Portable infusion devices for single use - Non electrically driven
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 18,145
Date of Issue 2023-09-05
Date of Implementation 2026-09-15
Older Standard (superseded by this standard) YY 0451-2010
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 the basic requirements and corresponding test methods for disposable portable infusion pumps - non-electrically driven (hereinafter referred to as infusion pumps). This standard applies to infusion pumps for continuous (fixed or adjustable) and/or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications. This document does not apply to: electric or electronically controlled infusion pumps covered by GB 9706.224; devices for single patient use for delivering discrete (bolus) medicinal liquids covered by the YY/T 1768 series; implantable devices; intestinal Feeding pump; transcutaneous infusion device; device in which infusion power is not provided by the device itself or obtained by active intervention of the patient (for example, a device powered only by gravity).