ANSI NSF 49-2016 Biosafety Cabinetry Design Construction Performance and Field Certification.pdf

1、NSF International Standard / American National StandardNSF/ANSI 49 - 2016 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.orgi NSF/ANSI 49 2016 NSF International Standard/ American Nation

4、al Standard for Biosafety Cabinetry Biosafety Cabinetry: Design, Construction, Performance, and Field Certification Standard Developer NSF International NSF International Designated an ANSI Standard June 24, 2016 American National Standards Institute ii Prepared by The NSF Joint Committee on Biosafe

5、ty 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 November 2011 Revised June 1987 Revised July 2012 Revised May 1992 Revised February 2015 Revised March 2002 Revised March 2017 Addendum Novemb

6、er 2002 Revised February 2004 Revised September 2004 Addendum October 2004 Addendum March 2005 Revised July 2007 Revised October 2008 Revised June 2009 Revised September 2010 Revised November 2010 Published by NSF International PO Box 130140, Ann Arbor, Michigan 48113-0140, USA For ordering copies o

7、r for making inquiries with regard to this Standard, please reference the designation “NSF/ANSI 49 2016.” Copyright 2017 NSF International Previous editions 2014, 2012, 2011, 2010, 2009, 2008, 2007, 2004, 2002, 1992, 1987, 1983, 1976 Unless otherwise specified, no part of this publication may be rep

8、roduced or utilized 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 Disclaimers1 NSF International (NSF), in performing its functions in accordance with its

9、 objectives, does 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

10、any obligation 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 ele

11、ctrical safety 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

12、 their agencys 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 illust

13、rations, if provided, 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 t

14、o justify improper 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. 1 The information containe

15、d in this Disclaimer 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 r

16、equirements necessary for conformance to the Standard. 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 . 1 3 Definitions . 3 4 Materials . 11 4.1 General. 11 4.2 Interior work

17、 surfaces . 11 4.3 Exposed interior surfaces. 11 4.4 Other interior and exterior surfaces . 11 4.5 Materials and finishes 11 5 Design and construction . 13 5.1 General. 13 5.2 Cleanability . 13 5.3 Decontamination 13 5.4 Canopy connect exhaust 13 5.5 Direct connect exhaust. 14 5.6 Duct and plenum de

18、sign 14 5.7 Internal corners and angles . 14 5.8 External corners and angles 14 5.9 Joints and seams . 14 5.10 Fastening methods 15 5.11 Welds . 15 5.12 Solder 15 5.13 Removable panels . 15 5.14 Stability 15 5.15 Provision for mounting . 15 5.16 Legs and feet . 16 5.17 Reinforcing and framing 16 5.1

19、8 Fixed panels 16 5.19 Doors and covers 16 5.20 Louvers and openings . 17 5.21 Tracks and guides . 17 5.22 Filters . 17 5.24 Stopcocks and service outlets . 18 5.25 Alarms 18 5.26 Electrical components . 19 5.27 Lighting 20 5.28 Gauges 20 5.29 Drain spillage trough 20 5.30 Diffuser placement . 20 5.

20、31 Work area components placement 20 5.32 Data plate(s) 20 5.33 Routine maintenance adjustment fixtures . 21 6 Performance . 28 6.1 General. 28 6.2 Pressure decay / soap bubble / tracer gas leak . 28 6.3 HEPA/ULPA filter leak 28 6.4 Noise level 28 6.5 Lighting intensity 28 6.6 Vibration . 28 6.7 Per

21、sonnel, 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 vi 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 6.17 Air velocity stability 31 Annex A . 33 Annex B . 79 Annex C. 83 Annex D. 87 Annex E . 89 Annex F . 129 Annex G 147 Annex H. 165 Annex I . 169 Annex J . 173 Annex K . 177 vii Foreword2 The purpose of this Standard is to establish minimum requirements for materials, des

23、ign, construction, and performance of 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 49-2016) includes the following re

24、visions: Issue 45 Changes were made to Annex G covering the addition of Vaporized Hydrogen Peroxide as a decontamination agent in Biosafety Cabinetry, as well as clarifying the use of Chlorine Dioxide . Issue 56 Language in section 6.14 was added regarding certification to IEC 61010-1 or a national

25、standard based on it. Issue 73 The newly designated C1 BSC was incorporated into the Standard. Issue 76 Updated language was added referencing audible and visual alarms. Issue 78 Metric conversions throughout the Standard were reviewed and updated. Issue 79 Decontamination procedures in Annex G were

26、 updated. Issue 81 This issue updated Annex E. Issue 86 Updates were made in Annex A to the incubation time and temperature prior to the micro check. Issue 88 Language in section 5.32 regarding cabinet height and width was removed. Issue 90 Redundancies about sliding sash alarms in subsections 5.19.

27、4 and 5.25.1 were removed. Issue 96 Language involving preparation of the spore suspension of Bacillus atrophaeus 9372 in Annex A was updated. Issue 99 The soap bubble leak test in Annex A was revised. This Standard was developed by the NSF Joint Committee on Biosafety Cabinetry using the consensus

28、process described by the American National Standards Institute. 2 The 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

29、 subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard. viii Suggestions for improvement of this Standard are welcome. This Standard is maintained on a Continuous Maintenance schedule and can be opened for comment a

30、t any time. Comments should be sent to Chair, Joint Committee on Biosafety Cabinetry at standardsnsf.org, or c/o NSF International, Standards Department, PO Box 130140, Ann Arbor, Michigan 48113-0140, USA. 1 2017 NSF NSF/ANSI 49 2016 NSF/ANSI Standard for Biosafety Cabinetry Biosafety Cabinetry: Des

31、ign, Construction, Performance, 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 suc

32、h cabinetry to meet this 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; limit

33、ations on noise level; 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

34、requirements. 1.3 Variations 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, a

35、nd performs in conformance 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 q

36、uantity or all three of 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;

37、location and size of exhaust 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 o

38、f this Standard are not compromised. 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 are en

39、couraged to investigate the possibility of applying the most recent editions of the documents indicated below. 2017 NSF NSF/ANSI 49 2016 2 ACGIH, Industrial Ventilation: A Manual of Recommended Practice3 ANSI 226.1 Test No. 174 ANSI/NFPA 70: National Electrical Code, 19995 APHA, Compendium of Method

40、s for Microbiological Examination of Foods, 1976 (Spore staining techniques)6 APHA, Standard Methods for the Examination of Water and Wastewater, Seventeenth Edition (Standard dilution plate methods)6 ASHRAE 111-2008: Practices for Measurement, Testing, Adjusting and Balancing of Building Heating, V

41、entilation, Air-Conditioning and Refrigeration Systems7 IEEE/ASTM SI 10, American National Standard for Metric Practice8 IEST-RP-CC001, Recommended Practice for HEPA Filters9 IEST-RP-CC007, Testing ULPA Filters9 IEST-RP-CC013, Institute of Environmental Sciences Recommended Practice, Tentative, Augu

42、st, 19869 IEST-RP-CC021, Testing HEPA and ULPA Filter Media9 MIL-F-51079B, Filters, Particulate, High Efficiency, Fire Resistant, Biological Use10 NIOSH Pocket Guide: bis(chloromethyl)ether11 OSHA, CFR 29 1910.100, Bloodborne Pathogens12 The Lighting Handbook: Reference and Application, 10th Edition

43、, 201113 UL 9414 3 American Conference of Governmental Industrial Hygienists, 1330 Kemper Meadow Dr., Cincinatti, OH 45240 4 American Public Health Association, 800 I Street NW, Washington, DC 20001 5 National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269 6 American Public Healt

44、h Association, 800 I Street NW, Washington, DC 20001 7 American Society of Heating, Refrigerating, and Air-Conditioning Engineers, 1791 Tullie Circle, N. E. Atlanta, GA 30329 8 ASTM International, 100 Barr Harbor Dr., West Conshohocken, PA 19428 www.astm.org 9 Institute of Environmental Sciences and

45、 Technology, 5005 Newport Drive, Suite 506, Rolling Meadows, IL 60008-1699 10 US Department of Defense, Navy Publishing and Printing Service Office, 700 Robins Ave., Philadelphia, PA 19111-5094 11 NIOSH, Department of Health and Human Services (DHHS), Publications Office, 4676 Columbia Pkwy., Cincin

46、nati, OH 45226 12 Superintendent of Documents, US Government Printing Office, Washington, DC 20402 13 Illuminating Engineering Society, 120 Wall Street, Floor 17, New York, NY 10005-4001 www.iesna.org 2017 NSF NSF/ANSI 49 2016 3 UL 61010A-114 UL 61010-114 3 Definitions 3.1 accessible: Fabricated to

47、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-filtered air as it flows downward through the work area, providing product and cross co

48、ntamination protection. The velocity is measured in a plane 4 inches (100 mm) above the bottom edge of the sash, when it is in its normal operating height. 3.2.2 downflow velocity profile: The individual downflow velocities as measured and averaged, on a predetermined grid pattern. Airflow velocitie

49、s 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 velocity 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