YY/T 1539-2025Medical clean bench (English PDF)
医用洁净工作台
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 30, 2025
Implementation date
November 1, 2027
Scope
YY/T 1539-2025 is the English-translated version of 医用洁净工作台.
YY/T 1539-2025 is the Chinese standard "Medical clean bench". Its scope clause reads: This document defines the types of medical clean benches (hereinafter referred to as clean benches), and specifies the requirements, labeling and accompanying documents, packaging, and transportation.
The contents and storage information are described, along with the corresponding experimental methods. This document applies to medical clean benches used in medical institutions. Its clauses include terms and definitions.
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Document preview — YY/T 1539-2025
National Standard of the People's Republic of China
- ICS
- 11.140
- Classification
- C44
- Replacing
- YY/T 1539-2017
Issued by: National Medical Products Administration
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Types of clean benches
- 4.1 According to airflow pattern
- 4.2 By Operation Method
- 5 Requirements
- 5.1 Appearance
- 5.2 Materials
- 5.3 Structure
- 5.4 Performance
- 6.Test Methods
- 6.1 Appearance
- 6.2 Materials
- 6.3 Structure
- 6.4 Performance
- 7 Tags and 20 Random Files
- 7.1 Tag
- 7.2 Random Files
- 8 Packaging, transportation and storage
- 8.1 Packaging Markings
- 8.2 Packaging
- 8.3 Transportation
- 8.4 Storage
- Appendix A (Informative) Inspection Rule
1 Scope
This document defines the types of medical clean benches (hereinafter referred to as clean benches), and specifies the requirements, labeling and accompanying documents, packaging, and transportation.
The contents and storage information are described, along with the corresponding experimental methods.
This document applies to medical clean benches used in medical institutions.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 191 Pictorial Symbols for Packaging and Storage
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measuring, control and laboratory use – Part 1.General requirements
GB/T 42125.1 Safety requirements for electrical equipment for measuring, control and laboratory use - Part 1.General requirements
Pharmacopoeia of the People's Republic of China
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Suitable for medical institutions, this box-type air purification system can provide local operating environments with a cleanliness level of ISO 5 (Class 100) or higher.
equipment.
Note. Common names for clean benches include clean workbench, ultra-clean workbench, medical clean workbench, and biological clean workbench.
3.2
The airflow flows from top to bottom and is perpendicular to the horizontal plane.
3.3
The airflow moves from one side to the other, and the airflow is parallel to the horizontal plane.
3.4 working area
The area where operations are performed inside the clean bench.
3.5 Product protection
Clean benches prevent airborne contaminants from outside from entering the work area through the front window operating port.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 18268.1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
- GB/T 42125.1Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements
Editions of YY/T 1539
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1539-2025 | Medical clean bench | current edition | Current |
| YY/T 1539-2017 | Medical clean bench | previous edition | In force until 2027-11-01 |
This page sells the current edition, YY/T 1539-2025. Earlier editions are listed for reference only.
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Related Standards
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 18268.1-2025 — Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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