NSF/ANSI 49 - 2018

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This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.NSF International Standard /American National StandardNSF/ANSI 49 - 2018Biosafety Cabinetry: Design,Construction, Performance,and Field Certification

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.NSF International, an independent, not-forprofit, non-governmental organization, isdedicated to being the leading globalprovider of public health and safety-basedrisk management solutions while servingthe 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 andinterpretations, or propose revisions by contacting:Chair, Joint Committee on Biosafety Cabinetryc/o NSF International789 North Dixboro Road, PO Box 130140Ann Arbor, Michigan 48113-0140 USAPhone: (734) 769-8010 Telex: 753215 NSF INTLFAX: (734) 769-0109E-mail: info@nsf.orgWeb: www.nsf.org

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.NSF/ANSI 49 – 2018NSF International Standard /American National Standardfor Biosafety Cabinery –Biosafety Cabinetry: Design,Construction, Performance,and Field CertificationStandard DeveloperNSF InternationalDesignated as an ANSI StandardMarch 5, 2018American National Standards Institutei

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.Prepared byThe NSF Joint Committee on Biosafety CabinetryRecommended for adoption byThe NSF Council of Public Health ConsultantsAdopted byThe NSF Board of TrusteesJune 1976Revised May 1983Revised March 2002Revised September 2004Revised July 2007Revised September 2010Revised July 2012Revised January 2019Revised June 1987Addendum November 2002Addendum October 2004Revised October 2008Revised November 2010Revised February 2015Revised May 1992Revised February 2004Addendum March 2005Revised June 2009Revised November 2011Revised March 2017Published byNSF InternationalPO Box 130140, Ann Arbor, Michigan 48113-0140, USAFor ordering copies or for making inquiries with regard to this Standard, please reference the designation“NSF/ANSI 49 – 2018.”Copyright 2019 NSF InternationalPrevious editions 2017, 2014, 2012, 2011, 2010, 2009, 2008, 2007, 2004, 2002, 1992, 1987, 1983, 1976Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by anymeans, electronic or mechanical, including photocopying and microfilm, without permission in writing fromNSF International.Printed in the United States of America.ii

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.Disclaimers 1NSF International (NSF), in performing its functions in accordance with its objectives, does not assume orundertake to discharge any responsibility of the manufacturer or any other party. The opinions and findingsof NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or relianceupon this Standard by anyone. NSF shall not incur any obligation or liability for damages, includingconsequential damages, arising out of or in connection with the use, interpretation of, or reliance upon thisStandard.NSF Standards provide basic criteria to promote sanitation and protection of the public health. Provisionsfor mechanical and electrical safety have not been included in this Standard because governmentalagencies or other national standards-setting organizations provide safety requirements.Participation in NSF's Standards development activities by regulatory agency representatives (federal,local, state) shall not constitute their agency's endorsement of NSF or any of its Standards.Preference is given to the use of performance criteria measurable by examination or testing inNSF Standards development when such performance criteria may reasonably be used in lieu of design,materials, or construction criteria.The illustrations, 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 showthe only method of fabricating such arrangements. Such partial drawings shall not be used to justifyimproper or incomplete design and construction.Unless otherwise referenced, the Annexes are not considered an integral part of NSF Standards. TheAnnexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifyingorganization.1The information contained in this Disclaimer is not part of this American National Standard (ANS) and has not beenprocessed in accordance with ANSI’s requirements for an ANS. As such, this Disclaimer may contain material thathas not been subjected to public review or a consensus process. In addition, it does not contain requirementsnecessary for conformance to the Standard.iii

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This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.Contents1General . 11.11.21.3Scope . 1Minimum requirements . 1Variations in design and construction . 12Normative references . 13Definitions . 34Materials . 114.14.24.34.44.55Design and construction . 75.285.295.305.315.325.336General . 11Interior work surfaces . 11Exposed interior surfaces . 11Other interior and exterior surfaces. 11Materials and finishes . 11General . 13Cleanability . 13Decontamination . 13Canopy exhaust connection . 13Direct exhaust connection . 14Duct and plenum design . 14Internal corners and angles . 14External corners and angles . 14Joints and seams . 14Fastening methods . 15Welds . 15Solder . 15Removable panels . 15Stability . 15Provision for mounting . 15Legs and feet. 16Reinforcing and framing . 16Fixed panels . 16Doors and covers . 16Louvers and openings . 17Tracks and guides . 17Filters . 17Gaskets and sealants . 18Stopcocks and service outlets. 18Alarms . 18Electrical components . 20Lighting . 20Gauges . 20Drain spillage trough . 21Diffuser placement . 21Work area components placement . 21Data plate(s) . 21Routine maintenance adjustment fixtures . 21Performance . 28v

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI .146.156.166.17General . 28Pressure decay / soap bubble / tracer gas leak . 28HEPA/ULPA filter leak . 28Noise level . 28Lighting intensity . 28Vibration . 28Personnel, product, and cross-contamination protection . 28Stability . 29Downflow and inflow velocities. 29Inflow velocity . 30Airflow smoke patterns . 30Drain spillage trough leakage. 30Motor / blower performance . 30Electrical safety . 31Performance data . 31Record maintenance . 31Air velocity stability . 31Annex A Performance tests . ressure decay or soap bubble . 33HEPA/ULPA filter leak test . 34Noise level test . 36Lighting intensity test . 37Vibration test . 37Personnel, product, and cross-contamination protection (biological) tests . 38Stability tests . 49Downflow velocity . 50Inflow velocity (face velocity) test . 52Airflow smoke patterns test . 55Drain spillage trough leakage test . 56Motor or blower performance . 57Cabinet airflow stability . 58Canopy connection test . 60Annex B . 83B.1Method to verify fitness for use of potential direct inflow measurement devices . 83Annex C Nebulizer selection and calibration . 85C.1C.2Selection. 85Calibration . 85Annex D Evaluation of chemical resistance and abrasion resistance of surfaces . 89D.1D.2Chemical resistance . 89Abrasion resistance . 89Annex E Biosafety cabinet selection, installation, use, lifespan, and decommissioning . 91E.1E.2E.3E.4E.5Institutional safety consultation . 91Risk assessment procedure . 91BSC Class and Type selection. 96Site review before BSC purchase . 104BSC arrival and certification . 106vi

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.E.6E.7E.8E.9E.10E.11Cleaning and disinfection of BSC work area. 107BSC use practices and procedures. 109Moving a permanently installed BSC . 113BSC lifespan. 113Decommissioning process . 113Definitions . 115Annex F Field tests . 133F.1F.2F.3F.4F.5F.6F.7F.8F.9F.10F.11F.12Field certification preconditions and intervals . 133Downflow velocity . 134Inflow velocity (face velocity) test . 135Airflow smoke patterns test . 139HEPA/ULPA filter leak test . 141Pressure decay / soap bubble. 143Site installation assessment tests . 144Electrical leakage and ground circuit resistance and polarity tests . 147Lighting intensity test . 147Vibration test . 148Noise level tests . 149Record of field certification . 150Annex G Field tests . 151G.1 Recommended biosafety cabinet decontamination procedure . 151G.2 Recommended HEPA/ULPA filter disposal procedures . 167Annex H Recommended materials, finishes, and construction . 169H.1H.2H.3H.4H.5H.6H.7H.8Sheet metal and finishes . 169Glass . 169HEPA/ULPA filter gasket materials . 169HEPA/ULPA filter case – Type IC . 170Specifications . 170Sealants . 170Fans . 170Components and wiring . 171Annex IReference standards and specifications pertinent to Class II biosafety cabinetry . 173I.1I.2I.3I.4Annex JJ.1J.2Miscellaneous publications . 173Federal specifications . 174Federal standards . 174Military specifications . 175. 177Helium leak test . 177Sulfur hexafluoride (SF6) leak test . 178Annex K Protocol for the validation of alternate biosafety cabinet decontaminating methods and agents . 181K.1K.2Introduction. 181Protocol . 181vii

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.This page is intentionally left blank.

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.Foreword 2The purpose of this Standard is to establish minimum requirements for materials, design, construction, andperformance 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 includes the following revisions:Issue 47Revised and added new language in Annex A regarding the cross contamination test procedure.Issue 59Revised and added new language for the airflow alarm requirement language for all cabinet types.Issue 77Added language to Annex A regarding confirmation tests when there is a test failure.Issue 105Added new language in Annex E regarding Risk assessment of biosafety cabinets exhaust systempressurization in the event of an exhaust system failure.Issue 108Added new language in Annex F regarding exhaust airflow alarms.Issue 109Revised and added new language referring to the term Certification throughout this Standard.Issue 110Revised language in Section 1.3 regarding the identification of major software changes to biosafetycabinetss.Issue 111Added new and revised language to Section 3 regarding the terms visible and viewable, and addedprovisions for the optional use of digital data plates to Section 5.Issue 112Revised and added new language in Annex G regarding the generation and dispersion of decontaminationgas.2The information contained in this Foreword is not part of this American National Standard (ANS) and has not beenprocessed in accordance with ANSI’s requirements for an ANS. As such, this Foreword may contain material that hasnot been subjected to public review or a consensus process. In addition, it does not contain requirements necessaryfor conformance to the Standard.ix

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store.Issue 115Added new language in Section 6.10 regarding inflow requirements for Type C1 Cabinets.Issue 117Updates the language throughout this Standard regarding the use of the term “and/or”.Issue 118Revised language in Section 5.25.3 and Annex F regarding the exhaust alarm in Type B biosafety cabinets.Issue 121Revised language in Section 5.26.2 regarding electrical wiring.Issue 125Revised language in Section 5.26.2 regarding the term ‘running power’.This Standard was developed by the NSF Joint Committee on Biosafety Cabinetry using the consensusprocess described by the American National Standards Institute.Suggestions for improvement of this Standard are welcome. This Standard is maintained on a ContinuousMaintenance schedule and can be opened for comment at any time. Comments should be sent to Chair,Joint Committee on Biosafety Cabinetry at standards@nsf.org, or c/o NSF International, StandardsDepartment, PO Box 130140, Ann Arbor, Michigan 48113-0140, USA.x

This is a preview of "NSF/ANSI 49-2018". Click here to purchase the full version from the ANSI store. 2019 NSFNSF/ANSI 49 – 2018NSF/ANSI Standardfor Biosafety Cabinetry ―Biosafety Cabinetry: Design, Construction,Performance, and Field Certification1 General1.1ScopeThis Standard applies to Class II (laminar flow) biosafety cabinetry designed to minimize hazards inherentin work with agents assigned to Biosafety Levels 1, 2, 3, or 4. It also defines the tests that shall be passedby such cabinetry to meet this Standard. This Standard includes basic requirements for the design,construction, and performance of biosafety cabinets (BSCs) that are intended to provide personnel, product,and environmental protection; reliable operation; durability and structural stability; cleanability; limitationson noise level; illumination; vibration; and motor / blower performance.1.2Minimum requirementsCabinets qualifying under this Standard shall have passed all of the designated tests. Units with componentparts covered under existing NSF Standards or Criteria shall conform to those applicable requirements.1.3Variations in design and constructionCabinetry varying in design, construction, or installation of accessory equipment may qualify under thisStandard, if appropriate tests and investigations indicate that the equipment is durable and reliable, can becleaned and decontaminated, and performs in conformance to this Standard. Such equipment shall meetthe requirements for materials and finishes in this Standard.Major modifications require appropriate tests for conformance. Major modifications include, but are notlimited to any of the following changes to the blower / motor(s): location, capacity, quantity, or automaticairflow adjustment; 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 andexhaust air grilles; window placement or design; access opening size; location and size of exhaust port; thevisibility or audibility of the safety signaling; and built-in accessory equipment (centrifuges, ultraviolet (UV)lighting, supports for intravenous drug container, arm rests, etc.). Major modifications also include changesaffecting the safe use of the cabinet including the ability to see, hear, and understand the required alarms.Relocation of utilit

NSF/ANSI 49 – 2018 . NSF International Standard / American National Standard . for Biosafety Cabinery – Biosafety Cabinetry: Design, Construction, Performance, and Field Certification. Standard Developer . NSF International . Designated as an ANSI Standard . March 5, 2018 . American National Standards Institute. This is a preview of "NSF .File Size: 892KBPage Count: 13

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