YY 0451-2023 PDF English
US$260.00 · In stock · Download in 9 secondsYY 0451-2023: Portable infusion devices for single use - Non electrically driven Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY 0451: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0451-2023 | English | 260 |
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Portable infusion devices for single use - Non electrically driven
| Valid |
| YY 0451-2010 | English | 150 |
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Portable infusion devices for single use - Non electrically driven
| Valid |
| YY 0451-2003 | English | 679 |
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5 days
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Single-use injectors for continuous ambulatory administration of medicinal products by parenteral route
| Obsolete |
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YY 0451-2023: Portable infusion devices for single use - Non electrically driven---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0451-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
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
Foreword
This document was drafted in accordance with the rules provided in GB/T 1.1-2020 Directives
for Standardization - Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This document serves as a replacement of YY 0451-2010 Portable Infusion Devices for Single
Use - Non Electrically Driven. In comparison with YY 0451-2010, apart from structural
adjustments and editorial modifications, the main technical changes are as follows.
---The Scope is modified (see Chapter 1; Chapter 1 of Version 2010);
---The “composition” is modified (see 4.1; 4.1 of Version 2010);
---The “materials” is modified (see 4.2; 4.2 of Version 2010);
---The “general principle” in Design and Characteristics is modified (see 4.3.1; 4.3.1 of
Version 2010);
---The “connectors” in Design and Characteristics is modified (see 4.3.2; 4.3.2 of Version
2010);
---The “filters” in Design and Characteristics is modified (see 4.3.3; 4.3.3 of Version 2010);
---The pressure resistance test is modified (see 6.3; 6.3 of Version 2010);
---The tensile strength test is modified (see 6.4; 6.6 of Version 2010);
---The drop test is modified (see 6.5; 6.4 of Version 2010);
---The information that shall be on the packaging and / or product is modified (see Chapter
7; Chapter 7 of Version 2010).
This document modifies and adopts ISO 28620.2020 Medical Devices - Non-electrically Driven
Portable Infusion Devices.
In comparison with ISO 28620.2020, this document makes the following structural adjustments.
---“particulate pollution” is added (see 4.3.6);
---“chemical properties” is added (see 4.5).
In comparison with ISO 28620.2020, there are many structural adjustments. Appendix A
provides a list of the corresponding technical differences and the causes for these differences.
This document also makes the following editorial modification.
---Appendix A (informative) “Technical Differences between This Document and ISO
28620.2020 and Their Causes” is added.
Please be noted that certain content of this document may involve patents. The institution
issuing this document does not undertake the responsibility of identifying these patents.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on Infusion
Equipment for Medical Use of Standardization Administration of China (SAC/TC 106).
The issuing of the previous versions.
---Firstly issued as YY 0451-2003 in 2003, and firstly revised in 2010;
---This is the second revision.
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).
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)
3 Terms and Definitions
The following terms and definitions are applicable to this document.
The ratio of the nominal volume (3.10) to the actual time required to infuse the solution.
4 General Requirements
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.
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
When tested in accordance with 6.7, the bolus volume shall not exceed 115% of the nominal
bolus volume.
6 Test Methods
In accordance with the instructions for use and the accompany documents, prepare the infusion
device [see 8c)], so that it can infuse solution.
7 Information That Shall Be on the Packaging and / or Product
The infusion device, sterile barrier system and / or protective packing shall be labeled with the
information provided in Table 1.
8 Accompanying Documents
The accompanying documents shall contain at least the following information.
Appendix A
(informative)
Technical Differences between This Document and ISO 28620.2020, and Causes for the
Differences
Appendix B
(normative)
Particulate Pollution Test3)
By rinsing the surface of the liquid channel in the inner cavity of the infusion device, collect
particles on the filter membrane, and use a microscope to count them.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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