YY/T 1550.3-2024Guidance on the study of compatibility of infusion equipment and pharmaceutical products - Part 3: Leachable study - Unknown substances (English PDF)
一次性使用输液器具与药物相容性研究指南 第3部分：可沥滤物研究 未知物
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 8, 2024
Implementation date
July 20, 2025
Scope
YY/T 1550.3-2024 is the English-translated version of 一次性使用输液器具与药物相容性研究指南 第3部分：可沥滤物研究 未知物.
YY/T 1550.3-2024 is the Chinese standard "Guidance on the study of compatibility of infusion equipment and pharmaceutical products - Part 3: Leachable study - Unknown substances".
Its scope clause reads: This document describes the process of single-use infusion sets in contact with drugs under simulated clinical infusion conditions or clinical infusion conditions.
Methods for the investigation of unknowns in leachables. This document applies to specific infusion sets that require studies of unknown leachables and, when necessary, alternative solvents or proposed solutions for the drug that have been demonstrated.
For drugs to be infused, unknown leachable substances should be studied. Other infusion devices can be used for reference if evaluation is required. Its clauses include terms and definitions.
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Document preview — YY/T 1550.3-2024
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C31
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General
- 5 Test methods
- 5.1 Preparation of extract
- 5.2 Characterization of unknown leachables
- 5.3 Sample determination
- 5.4 Result calculation
- 6 Research report content
- References
1 Scope
This document describes the process of single-use infusion sets in contact with drugs under simulated clinical infusion conditions or clinical infusion conditions.
Methods for the investigation of unknowns in leachables.
This document applies to specific infusion sets that require studies of unknown leachables and, when necessary, alternative solvents or proposed solutions for the drug that have been demonstrated.
For drugs to be infused, unknown leachable substances should be studied. Other infusion devices can be used for reference if evaluation is required.
2 Normative references
This document has no normative references.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
threshold below which the analyst need not characterize, analyze, or characterize extractables or leachables for potential toxicological evaluation.
Quantification or reporting.
[Source. GB/T 16886.18-2022, 3.2]
3.2
A method designed to detect, identify, and semi-quantitatively estimate all relevant analytes present in test samples at concentrations above established reporting thresholds (e.g., AETs).
method.
[Source. GB/T 16886.18-2022, 3.4]
3.3 Qualitative identification
Assign molecular structures and chemical names to organic compounds, and assign constituent elements or, as appropriate, molecular structures and their chemical names to inorganic compounds.
Chemical name of the process.
[Source. GB/T 16886.18-2022, 3.19]
3.4 Quantification
The process of determining the concentration of an analyte in a sample.
[Source. GB/T 16886.18-2022, 3.30]
3.5 Semi-quantitative analysis
The concentration of the analyte is provided by using the response of one or more surrogate substances and the analyte and surrogate phases are specifically stated.
Methods for analyzing responses.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.
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Related Standards
YY/T 1550.2-2019 — Guidance on the study of compatibility between infusion equipment and pharmaceutical products - Part 2: Leachables - Known substances
YY/T 1550.1-2017 — Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 1: Drug sorption
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1550.3-2024
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