YY/T 1539-2017 (YYT1539-2017)

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YY/T 1539-2017
Medical clean bench
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Medical clean bench
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword I
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 type of clean bench 2
4.1 Classification by airflow pattern 2
4.2 Classification by operation mode 2
5 Requirements 2
5.1 Appearance 2
5.2 Material 2
5.3 Structure 2
5.4 Performance 3
6 Test method 5
6.1 Appearance 5
6.2 Material 5
6.3 Structure 5
6.4 Performance 5
7 labels, tags 12
7.1 Nameplate 12
7.2 Random File 12
8 Packaging, transportation and storage 12
8.1 Packing 12
8.2 Transportation 12
8.3 Storage 13
Appendix A (informative) Inspection Rules 14
A.1 Inspection type 14
A.2 Factory inspection 14
A.3 Type inspection 14
A.4 Installation inspection 14
A.5 Annual Maintenance Inspection 14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the Beijing Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Wang Huiru, Wang Qiqi, War, Zhang Yuchen.
Medical clean bench
1 Scope
This standard specifies the terms and definitions of clean benches, classification types, materials, structures and performance requirements, test methods, inspection rules,
Requirements for labels, markings, random documents, packaging, shipping and storage.
This standard applies to clean work stations (hereinafter referred to as clean benches) for use by medical institutions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Clean bench cleanbench
The clean bench is a medical operating system that provides a partial operating ring with a clean rating of ISO 5 (Class 100) or higher.
Box air purification equipment.
Note. Common names for clean benches include clean benches, ultra-clean benches, medical clean benches, and bio-clean benches.
3.2
Vertical flow verticalunidirectionalairflow
The airflow flows from the top to the bottom, and the airflow is perpendicular to the horizontal plane.
3.3
Horizontal flow horizontalunidirectionalairflow
The air flow flows from side to side and the air flow is parallel to the horizontal plane.
3.4
Workspace workingarea
The part of the clean bench that operates.
3.5
Product protection protection
The clean bench prevents airborne contaminants from the outside from entering the work area through the operating port.
3.6
High efficiency filter highefficiencyparticulateair(HEPA)filter
A disposable dry filter with extended/pleated media featuring the following.
---The hard outer shell is filled with pleats;
--- For particulates with a diameter of 0.3μm, the filtration efficiency is not less than 99.99%;
---The clean filter has a maximum pressure drop of 250Pa when operating at rated flow;
--- When the scanning test is carried out with a polydisperse aerosol with a light scattering median size of 0.7 μm and a geometric standard deviation of 2.4, the transmission rate is not exceeded.
Over 0.01%.
3.7
Effective flow rate range theeffectiverangeofvelocity
The flow rate