1、NSF International Standard / American National StandardNSF/ANSI 49 - 2014 Biosafety Cabinetry: Design, Construction, Performance, and Field CertificationNSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public healt
2、h and safety-based risk management solutions while serving the interests of all stakeholders. This Standard is subject to revision. Contact NSF to confirm this revision is current. Users of this Standard may request clarifications and interpretations, or propose revisions by contacting: Chair, Joint
3、 Committee on Biosafety Cabinetry c/o NSF International 789 North Dixboro Road, P.O. Box 130140 Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL FAX: (734) 769-0109 E-mail: infonsf.org Web: http:/www.nsf.org i NSF/ANSI 49 2014 NSF International Standard/ American Natio
4、nal Standard for Drinking Water Additives Biosafety Cabinetry: Design, Construction, Performance, and Field Certification Standard Developer NSF International NSF International Designated an ANSI Standard September 19, 2014 American National Standards Institute ii Prepared by The NSF Joint Committee
5、 on Biosafety Cabinetry Recommended for Adoption by The NSF Council of Public Health Consultants Adopted by The NSF Board of Trustees June 1976 Revised May 1983 Revised June 1987 Revised May 1992 Revised March 2002 Addendum November 2002 Revised February 2004 Revised September 2004 Addendum October
6、2004 Addendum March 2005 Revised July 2007 Revised October 2008 Revised June 2009 Revised September 2010 Revised November 2010 Revised November 2011 Revised July 2012 Revised February 2015 Published by NSF International PO Box 130140, Ann Arbor, Michigan 48113-0140, USA For ordering copies or for ma
7、king inquiries with regard to this Standard, please reference the designation “NSF/ANSI 49 2014.” Copyright 2014 NSF International Previous editions 2012, 2011, 2010, 2009, 2008, 2007, 2004, 2002, 1992, 1987, 1983, 1976 Unless otherwise specified, no part of this publication may be reproduced or uti
8、lized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International. Printed in the United States of America. iii Disclaimers1NSF International (NSF), in performing its functions in accordance with its objectives, do
9、es not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Standard by anyone. NSF shall not incur any obligation
10、or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard. NSF Standards provide basic criteria to promote sanitation and protection of the public health. Provisions for mechanical and electrical safety
11、have not been included in this Standard because governmental agencies or other national standards-setting organizations provide safety requirements. Participation in NSFs Standards development activities by regulatory agency representatives (federal, local, state) shall not constitute their agencys
12、endorsement of NSF or any of its Standards. Preference is given to the use of performance criteria measurable by examination or testing in NSF Standards development when such performance criteria may reasonably be used in lieu of design, materials, or construction criteria. The illustrations, if pro
13、vided, are intended to assist in understanding their adjacent standard requirements. However, the illustrations may not include all requirements for a specific product or unit, nor do they show the only method of fabricating such arrangements. Such partial drawings shall not be used to justify impro
14、per or incomplete design and construction. Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The annexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifying organization. 1The information contained in this Discla
15、imer is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. As such, this Disclaimer may contain material that has not been subjected to public review or a consensus process. In addition, it does not contain requirements nece
16、ssary for conformance to the Standard. iv This page is intentionally left blank. v Contents 1 General . 1 1.1 Scope . 1 1.2 Minimum requirements 1 1.3 Variations in design and construction 1 2 Normative references 2 3 Definitions . 3 4 Materials . 10 4.1 General . 10 4.2 Interior work surfaces 10 4.
17、3 Exposed interior surfaces 10 4.4 Other interior and exterior surfaces . 11 4.5 Materials and finishes . 11 5 Design and construction 12 5.1 General . 12 5.2 Cleanability . 12 5.3 Decontamination . 12 5.4 Canopy connect exhaust . 13 5.5 Direct connect exhaust 13 5.6 Duct and plenum design 13 5.7 In
18、ternal corners and angles . 13 5.8 External corners and angles 13 5.9 Joints and seams 14 5.10 Fastening methods . 14 5.11 Welds . 14 5.12 Solder . 14 5.13 Removable panels 14 5.14 Stability . 15 5.15 Provision for mounting 15 5.16 Legs and feet 15 5.17 Reinforcing and framing 15 5.18 Fixed panels .
19、 15 5.19 Doors and covers 15 5.20 Louvers and openings . 16 5.21 Tracks and guides 16 5.22 Filters . 16 5.23 Gaskets and sealants . 17 5.24 Stopcocks and service outlets . 17 5.25 Alarms 17 5.26 Electrical components . 18 5.27 Lighting . 18 5.28 Gauges . 19 5.29 Drain spillage trough . 19 5.30 Diffu
20、ser placement 19 5.31 Work area components placement 19 5.32 Height and width . 19 5.33 Data plate(s) . 19 6 Performance . 28 6.1 General . 28 6.2 Pressure decay / soap bubble / tracer gas leak . 28 vi 6.3 HEPA/ULPA filter leak . 28 6.4 Noise level 28 6.5 Lighting intensity . 28 6.6 Vibration . 28 6
21、.7 Personnel, product, and cross-contamination protection 28 6.8 Stability . 29 6.9 Downflow and inflow velocities 29 6.10 Inflow velocity . 30 6.11 Airflow smoke patterns 30 6.12 Drain spillage trough leakage 31 6.13 Motor/blower performance 31 6.14 Electrical safety 31 6.15 Performance data . 31 6
22、.16 Record maintenance . 31 Annex A . A1 Annex B . B1 Annex C . C1 Annex D . D1 Annex E . E1 Annex F . F1 Annex G G1 Annex H . H1 Annex I I1 Annex J . J1 Annex K . K1 vii Foreword2The purpose of this Standard is to establish minimum requirements for materials, design, construction, and performance o
23、f Biosafety Cabinetry that are designed to protect personnel, product, and the environment. This Standard details requirements for performance testing as well as field certification testing. This edition of the Standard (NSF/ANSI 49-2014) includes the following revisions: Issue 48: This revision add
24、s a motor stability test procedure for motor speed control systems. Issue 49: This revision updates the Sealant use language in Annex H. Issue 50: This revision affirms new language regarding the type of fans used in Biosafety Cabinets. Issue 51: This revision affirms new language regarding the Type
25、 Biosafety Cabinet blower startup. Issue 52: This revision clarifies details surrounding the DOP port location in section 5.22. Issue 53: This revision adds definitions to clarify biosafety cabinet shell penetrations and cable ports with considerations given to service technicians and cabinet users
26、relating to safety. Issue 55: This revision updates the instrumentation language. Issue 60: This revision updates the Airflow Grid language in sections A.8.3.1 and A.8.3.2, and the related figure A15. Issue 61: This revision updates the language in sections 5.19.4 and 5.25.1 to include a section req
27、uiring the use of a sash position too low alarm. Issue 72: This revision updates multiple figures throughout the Standard to improve clarity. This Standard was developed by the NSF Joint Committee on Biosafety Cabinetry using the consensus process described by the American National Standards Institu
28、te. Suggestions for improvement of this Standard are welcome. This Standard is maintained on a Continuous Maintenance schedule and can be opened for comment at any time. Comments should be sent to Chair, Joint Committee on Biosafety Cabinetry at standardsnsf.org, or c/o NSF International, Standards
29、Department, PO Box 130140, Ann Arbor, Michigan 48113-0140, USA. 2The information contained in this Foreword is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. As such, this Foreword may contain material that has not been
30、subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard. viii This page is intentionally left blank.1 2015 NSF NSF/ANSI 49 2014 NSF/ANSI Standard for Biosafety Cabinetry Biosafety Cabinetry: Design, Construction, Perf
31、ormance, and Field Certification 1 General 1.1 Scope This Standard applies to Class II (laminar flow) biosafety cabinetry designed to minimize hazards inherent in work with agents assigned to biosafety levels 1, 2, 3, or 4. It also defines the tests that shall be passed by such cabinetry to meet thi
32、s Standard. This Standard includes basic requirements for the design, construction, and performance of biosafety cabinets that are intended to provide personnel, product, and environmental protection; reliable operation; durability and structural stability; cleanability; limitations on noise level;
33、illumination; vibration; and motor/blower performance. 1.2 Minimum requirements Cabinets qualifying under this Standard shall have passed all of the designated tests. Units with component parts covered under existing NSF standards or criteria shall conform to those applicable requirements. 1.3 Varia
34、tions in design and construction Cabinetry varying in design, construction, or installation of accessory equipment may qualify under this Standard, if appropriate tests and investigations indicate that the equipment is durable and reliable, can be cleaned and decontaminated, and performs in conforma
35、nce to this Standard. Such equipment shall meet the requirements for materials and finishes in this Standard. Major modifications require appropriate tests for conformance. Major modifications include, but are not limited to, changes in the following: location or capacity or quantity or all three of
36、 blower/motor(s); size or design or both of air plenums; position of High Efficiency Particulate Air/Ultra Low Penetrating Air (HEPA/ULPA) filters; position or redesign of work surface; work area intake and exhaust air grilles; window placement or design; access opening size; location and size of ex
37、haust port; and built-in accessory equipment (centrifuges, ultraviolet lighting, supports for intravenous drug container, arm rests, etc.). Relocation of utility service equipment (electrical outlets, petcocks, etc.) is not considered a major modification if other provisions of this Standard are not
38、 compromised. 2015 NSF NSF/ANSI 49 2014 2 2 Normative references The following documents contain requirements that, by reference in this text, constitute requirements of this Standard. At the time of publication, the indicated editions were valid. All documents are subject to revision, and parties a
39、re encouraged to investigate the possibility of applying the most recent editions of the documents indicated below. ACGIH, Industrial Ventilation: A Manual of Recommended Practice3ANSI 226.1 Test No. 174 ANSI/NFPA 70: National Electrical Code, 19995APHA, Compendium of Methods for Microbiological Exa
40、mination of Foods, 1976 (Spore staining techniques)6APHA, Standard Methods for the Examination of Water and Wastewater, Seventeenth Edition (Standard dilution plate methods)6ASHRAE 111-2008: Practices for Measurement, Testing, Adjusting and Balancing of Building Heating, Ventilation, Air-Conditionin
41、g and Refrigeration Systems7IEST-RP-CC001, Recommended Practice for HEPA Filters8IEST-RP-CC007, Testing ULPA Filters8IEST-RP-CC013, Institute of Environmental Sciences Recommended Practice, Tentative, August, 19868IEST-RP-CC021, Testing HEPA and ULPA Filter Media8MIL-F-51079B, Filters, Particulate,
42、High Efficiency, Fire Resistant, Biological Use9NIOSH Pocket Guide: bis(chloromethyl)ether10OSHA, CFR 29 1910.100, Bloodborne Pathogens11The Lighting Handbook: Reference and Application, 10thEdition, 2011123American Conference of Governmental Industrial Hygienists, 1330 Kemper Meadow Dr., Cincinatti
43、, OH 45240 4American Public Health Association, 800 I Street NW, Washington, DC 20001 5National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269 6American Public Health Association, 800 I Street NW, Washington, DC 20001 7American Society of Heating, Refrigerating, and Air-Condition
44、ing Engineers, 1791 Tullie Circle, N. E. Atlanta, GA 30329 8Institute of Environmental Sciences and Technology, 5005 Newport Drive, Suite 506, Rolling Meadows, IL 60008-1699 9US Department of Defense, Navy Publishing and Printing Service Office, 700 Robins Ave., Philadelphia, PA 19111-5094 10NIOSH,
45、Department of Health and Human Services (DHHS), Publications Office, 4676 Columbia Pkwy., Cincinnati, OH 45226 11 Superintendent of Documents, US Government Printing Office, Washington, DC 20402 12 Illuminating Engineering Society, 120 Wall Street, Floor 17, New York, NY 10005-4001 2015 NSF NSF/ANSI
46、 49 2014 3 UL 9413UL 61010A-113UL 61010-1133 Definitions 3.1 accessible: Fabricated to be exposed for cleaning and visual inspection using simple tools (screwdriver, pliers, open-end wrench, etc. Also see definition of “readily accessible.“) 3.2 airflow 3.2.1 downflow velocity: The velocity of HEPA-
47、filtered air as it flows downward through the work area, providing product and cross contamination protection. The velocity is measured in a plane 4 in (10 cm) above the bottom edge of the sash, when it is in its normal operating height. 3.2.2 downflow velocity profile: The individual downflow veloc
48、ities as measured and averaged, on a predetermined grid pattern. Airflow velocities and the average of the airflow through the work area may be calculated as a whole (Uniform) or may be separated into 2 or more adjoining areas (Zoned) with averages calculated for each zone. 3.2.3 inflow: The velocit
49、y or volume of air that flows from the room into the Front Access Opening, providing an air barrier to prevent the escape of aerosols generated in the cabinets workzone. 3.2.4 unidirectional airflow: Air traveling through an area in a single pass in the same direction at a uniform speed to minimize potential cross contamination from aerosols. 3.2.5 non-uniform (zoned) downflow: A downflow velocity profile comprised of several contiguous zones. The average downflow velocities vary from zone to zone. 3.2.6 uniform downflow: A downflow velocity profile wherei
