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YY/T 1540-2017

Chinese Standard: 'YY/T 1540-2017'
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YY/T 1540-2017English279 Add to Cart Days<=3 Guide for the check of medical class Ⅱ biological safety cabinets Valid YY/T 1540-2017
YY/T 1540-2017Chinese18 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY/T 1540-2017 (YY/T1540-2017)
Description (Translated English) Guide for the check of medical class �� biological safety cabinets
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C48
Classification of International Standard 11.140
Word Count Estimation 14,190
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Drafting Organization Beijing Medical Device Inspection Institute
Administrative Organization State Food and Drug Administration Beijing Medical Device Quality Supervision and Inspection Center
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1540-2017
Guide for the check of medical class Ⅱ biological safety cabinets
ICS 11.140
C48
People's Republic of China pharmaceutical industry standards
Medical grade Ⅱ biological safety cabinet inspection guide
2017-05-02 released
2018-04-01 implementation
State Food and Drug Administration released
Directory
Preface Ⅰ
Introduction Ⅱ
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 2
4.1 Acceptance Verification 2
4.2 inspection inspection 2
4.3 Annual Verification 2
4.4 Verification records 3
4.5 Verification conclusion 3
5 test methods 4
5.1 Appearance 4
5.2 sampling port 4
5.3 Alarm and interlocking system 4
5.4 wind speed display 4
5.5 high efficiency filter integrity 5
5.6 Noise 5
5.7 illumination 6
5.8 down the air flow rate 6
5.9 Inflow air flow rate 6
5.10 Airflow Mode 7
5.11 UV lamp (if any) 7
5.12 Personnel, Products and Cross-contamination Protection 7
Appendix A (Informative) Class Ⅱ biological safety cabinet verification of the original record 10
A.1 Acceptance Verification Record Form 10
A.2 Inspection Record Form 10
A.3 Annual Verification Records Form 11
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the State Food and Drug Administration Beijing Medical Device Quality Supervision and Inspection Center.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Levin, Wang Zazaki, warfare, Zhang Yuchen.
introduction
The purpose of this standard is to verify the performance of Class II biological safety cabinets in medical institutions, to establish standardized methods, requirements and test methods
Provided a guide.
To ensure that Class II biological safety cabinets in normal use, the need for regular verification. This standard specifies the acceptance inspection, inspection
Verification and annual verification of the three types of verification. Acceptance inspection refers to the installation of Class Ⅱ biological safety cabinet after the mobile location and replacement of high efficiency
Filter and internal components after maintenance performance verification; inspection inspection is a simple quarterly check on the operation of equipment; annual inspection is to inspect
Verification added, provides for a more detailed verification.
Inspectors of medical institutions, such as medical practitioners, undertake inspection inspections. Acceptance verification, annual verification by a skilled verifier,
Such as biomedical engineers, medical physicists, medical equipment maintenance personnel, professional inspectors, inspection agencies, or manufacturers bear.
This standard does not include the requirements of disinfection and sterilization procedures.
Medical grade Ⅱ biological safety cabinet inspection guide
1 Scope
This standard specifies the medical institutions Ⅱ level biological safety cabinet (hereinafter referred to as "safety cabinet") acceptance inspection, inspection inspection and annual verification
Requirements and test methods.
The methods described in this standard are intended to assist users of safety cabinets in verifying the performance of such equipment and are intended primarily for medical practitioners, students
Medical engineers, medical physicians, medical equipment maintenance personnel, professional inspectors, inspection agencies or manufacturers.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY 0569-2011 Class Ⅱ biological safety cabinet
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Ⅱ biological safety cabinets class Ⅱbiologicalsafetycabinet; BSC
Negative pressure filtration exhaust hood, to prevent the operator and the environment exposed to bioaerosols generated during the experiment.
Class II cabinets have a front window operator, the operator can operate through the front window in the safety cabinet, the front window to inhale mouth
Of the negative pressure air flow to protect the operator's safety; the descending air flow filtered by the high efficiency filter is used to protect the experimental items in the safety cabinet; the air flow
Filter by high-efficiency filter and discharge safety cabinet to protect the environment. Safety cabinet according to the proportion of exhaust gas flow accounts for the total system flow and internal design structure
Divided into A1, A2, B1, B2 total of four types. A1 and A2 type of 70% gas circulation, 30% gas efflux; B1 type of 30% gas circulation
Ring, 70% gas efflux; B2 type 100% gas efflux. As B1 and B2 type safety cabinet gas exhaust need to connect a dedicated exhaust line,
Therefore, the test method of its discharge filter and A1, A2 efflux filter test different.
3.2
Inspector inspector
After professional training, with the appropriate qualifications, access to safety cabinets for performance testing of personnel, including medical practitioners, biomedical
Engineers, medical physicists, medical equipment maintenance personnel, professional inspectors, inspection agencies, or manufacturers.
3.3
Nominal flow rate nominalsetpointvelocities
The safety cabinet operating point specified by the manufacturer is the descending and inflow airflow rates set by the safety cabinet during normal operation.
3.4
Check check
Systematic actions taken to ensure the safety and effectiveness of safety cabinets in medical facilities include acceptance checks, inspections and annual inspections.
3.5 Acceptance Verification
After the safety cabinets have been delivered to the customer for the first test and after the position has been changed, replace the high-efficiency filter and internal parts after repair
test.
Related standard:   YY/T 1539-2017  YY/T 1477.5-2020
Related PDF sample:   YY/T 1477.4-2017  YY/T 1511-2017
   
 
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