ANSI American Society of Safety Engineers Z9.14-2014 Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety L.pdf

1、Printed in U.S.A.ASSEAMERICAN SOCIETY OFSAFETY ENGINEERSAMERICAN NATIONAL STANDARDANSI/ASSE Z9.14 2014ANSI/ASSE Z9.14 2014 Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) FacilitiesANSI/ASSE Z9.14 2014The

2、information and materials contained in this publication have been developed from sources believed to be reliable. However, the American Society of Safety Engineers (ASSE) as secretariat of the ANSI accredited Z9 Committee or individual committee members accept no legal responsibility for the correct

3、ness or completeness of this material or its application to specific factual situations. By publication of this standard, ASSE or the Z9 Committee does not ensure that adherence to these recommendations will protect the safety or health of any persons, or preserve property. ANSI ANSI/ASSE Z9.14 2014

4、 American National Standard Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities Secretariat American Society of Safety Engineers 1800 East Oakton Street Des Plaines, Illinois 60018-2187 Approved Jan

5、uary 24, 2014 American National Standards Institute, Inc. Approval of an American National Standard requires verification by ANSI that the requirements for due process, consensus, and other criteria for approval have been met by the standards developer. Consensus is established when, in the judgment

6、 of the ANSI Board of Standards Review, substantial agreement has been reached by directly and materially affected interests. Substantial agreement means much more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that a concer

7、ted effort be made toward their resolution. The use of American National Standards is completely voluntary; their existence does not in any respect preclude anyone, whether he/she has approved the standards or not, from manufacturing, marketing, purchasing or using products, processes or procedures

8、not conforming to the standards. The American National Standards Institute does not develop standards and will in no circumstance give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation of an American National Standar

9、d in the name of the American National Standards Institute. Requests for interpretation should be addressed to the secretariat or sponsor whose name appears on the title page of this standard. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of

10、the American National Standards Institute require that action be taken periodically to reaffirm, revise, or withdraw this standard. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. Published Fe

11、bruary 2014 by American Society of Safety Engineers 1800 East Oakton Street Des Plaines, Illinois 60018-2187 (847) 699-2929 www.asse.org Copyright 2014 by American Society of Safety Engineers All Rights Reserved. No part of this publication may be reproduced in any form, in an electronic retrieval s

12、ystem or otherwise, without the prior written permission of the publisher. Printed in the United States of America American National Standard FOREWORD (This Foreword is not part of the American National Standard ANSI/ASSE Z9.142014.) The Z9.14 Subcommittee was chartered to develop the American Natio

13、nal Standard, Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities. Over 1,000 BSL-3/ABSL-3 laboratories and animal facilities have been constructed in the United States. The design for their ventila

14、tion systems has been largely guided by the criteria defined in successive versions of Biosafety in Microbiological and Biomedical Laboratories (BMBL) from the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health

15、(NIH) (Biosafety in Microbiological and Biomedical Laboratories (BMBL) n.d.)1;the American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) standards2; U.S. Department of Agriculture Animal Research Service (USDA ARS) 242.1 Manual3; World Health Organization (WHO) Biosafety

16、Guidelines: Biosafety Manual4; and the National Institutes of Health Design Requirements Manual (DRM).5 Many of these guidelines offer design requirements, but lack the testing and performance-verification methodology to ensure the safe operation of the ventilation system for these laboratories. Usi

17、ng a risk assessment and performance-based approach, this standard provides the technical specifications and background information needed to address the technical, engineering, and associated systems for ventilation within a BSL-3/ABSL-3 laboratory. As such, it is fully compatible with biorisk-mana

18、gement systems and national and international health and safety management systems without duplicating or contradicting their requirements. The purpose of the ventilation system is to provide the necessary environment for biocontainment, occupational health, and animal health in accordance with stan

19、dards and containment guidelines. It specifically is designed to prevent unintended release of aerosolized infectious biological agents. The ANSI Z9.14 standard provides the combined knowledge acquired over the years by biosafety professionals, design professionals, and owners/operators of BSL-3/ABS

20、L-3 laboratories, which establishes the requirements and methodologies for the testing and performance verification of the ventilation system. The ANSI Z9.14 standard focuses specifically on the ventilation system features of BSL-3/ ABSL-3 facilities. Because the ventilation system is affected by an

21、d has an effect on other systems and equipment in a laboratory, those systems and equipment may be included in the standard, to some extent, as an associated system. ANSI Z9.14 provides testing standardization, uniformity, and consistency through the use of minimal performance-based testing and veri

22、fication methodologies for BSL-3/ABSL-3 ventilation systems in facilities. How to Read This Standard ANSI Z9.14 is presented in a two-column format. Beginning with section 5.0, Applicability and Conformance, the left column presents the requirements of the standard; the right column provides clarifi

23、cation and explanation of the requirements and information on “how to comply” to the standard. The standard contains appendices that are informative and are not considered a mandatory part of the standard. The standard is not meant to be all-encompassing. Rather, it establishes minimum acceptable cr

24、iteria for completing the verification process and documenting the necessary information for regulatory and historical purposes. It is somewhat general in nature so that it can be applied to any BSL-3/ABSL-3 laboratory. We hope, however, that future versions will continue to expand and amplify these

25、 concepts as additional experience is gained. Suggestions for improvement of this standard are welcome. They should be sent to: American Society of Safety Engineers, 1800 East Oakton Street, Des Plaines, IL 60018-2187. This standard was processed and approved for submittal to ANSI by the American Na

26、tional Standards Committee on Ventilation Systems. Approval of the standard does not necessarily imply (nor is it required) that all Committee members voted for its approval. At the time ANSI approved this standard, the Z9 Committee had the following members: Theodore Knutson, MS, P.E., Chair Geoffr

27、ey Raifsnider, P.E., Vice Chair Timothy R. Fisher, CSP, CHMM, ARM, CPEA, Secretary Jennie Dalesandro, Administrative Technical Support Organization Represented Name of Representative American Foundry Society Robert Scholz American Industrial Hygiene Association Lou DeBerardinis, CIH, CSP, MIT Americ

28、an Society of Heating, Refrigerating and downdraft tables 8. Document validation 9. Pressure reversal 10. Failure testing 11. Leakage issues related to HVAC 12. Qualifications of testers ANSI Z9.14 focuses on performance verification of ventilation system-engineering controls and related systems wit

29、hin a BSL-3/ABSL-3 laboratory. Testing and verification of ventilation systems in BSL-3/ABSL-3 labs include: Supply Exhaust Directional airflow Biosafety cabinets Air filtration Exhaust stacks Fan failure scenarios Redundancy Canopy hoods (autoclaves) Specific ABSL-3 requirements Testing and verific

30、ation of related systems within BSL-3/ABSL-3 labs include: Optimizing maintenance of pressure gradients and maintaining temperature and humidity Physical integrity AMERICAN NATIONAL STANDARD Z9.14-2014 3 Sealing and leakage factors Interlocking systems Airlocks Doors/windows Emergency and backup pow

31、er systems Alarms Operating sequences 4 DEFINITIONS Acceptance criteria The indicators and agreed-upon requirements established by project stakeholders (standard-setting authorities, the institution, occupants, etc.) to determine when a space or component of a facility, e.g., a laboratory ventilatio

32、n system, is adequate or meets design criteria and intent. Animal biosafety level 3 (ABSL-3) A level of laboratory containment that is suitable for work with laboratory animals infected with indigenous or exotic agents, agents that present a potential for aerosol transmission, and agents causing ser

33、ious or potentially lethal disease. ABSL-3 containment builds on the standard practices, procedures, containment equipment, and facility requirements of ABSL-2.1Anteroom For the purpose of this standard, “anteroom” refers to the zone between the two self-closing doors in a facility designed to minim

34、ize air escaping from the containment space (e.g., laboratory, animal room, or central containment corridor) into non-containment spaces. Authority having jurisdiction (AHJ) An organization, office, or individual responsible for enforcing the requirements of a code or standard, or for approving equi

35、pment, materials, an installation, or a procedure.6Automatic transfer switch (ATS) An automatic device for transferring one or more load conductor connections from one power source to another. Biocontainment The practices, techniques, equipment, and facilities needed to contain biohazardous material

36、s such as pathogenic microorganisms or toxins and preventing their release into the environment, thus minimizing worker exposure. Biocontainment includes the physical containment barriers in a facility, such as contained dressing and shower rooms, sealed service penetrations, specialized doors, entr

37、y and exit avenues to prevent cross-contamination, specialized air-handling systems for contamination control, personal protective equipment, biosafety cabinets and other primary containment devices, etc. Biohazard (biological hazard, hazardous biological agent) 1) An infectious or otherwise harmful

38、 biological agent or part thereof presenting a real or potential risk to humans, animals, plants, or the AMERICAN NATIONAL STANDARD Z9.14-2014 4 environment7; 2) A potential source of harm caused by biological agents or toxins.8Biological safety cabinet (BSC)7 An enclosed cabinet designed to serve a

39、s the primary means of containment for working safely with infectious microorganisms. A biosafety cabinet provides personnel, environmental, and product protection when appropriate practices and procedures are followed. Three kinds of biological safety cabinets, designated as Class I, II, and III, h

40、ave been developed to meet varying research and clinical needs. Most biosafety cabinets use high-efficiency particulate air (HEPA) filters in the exhaust and supply systems. The exception is a Class I biosafety cabinet, which does not have HEPA-filtered supply air. Different kinds of Class II biosaf

41、ety cabinets are used for different containment needs. They include Class II Type A1 cabinets (formerly designated Type A), Class II Type A2 cabinets (when exhausted to the environment, were formerly designated Type B3), and Class II Type B1 and B2 cabinets.1Biological safety manual A collection of

42、standard operating procedures (SOPs), training documents, responsibilities, etc., that is specific to a facility. Biorisk (biological risk) A combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin. The source of harm

43、 may be accidental or deliberate.8 Biorisk assessment See also “Risk assessment” The process of evaluating the biological risk(s) arising from a biohazard(s), taking into account the adequacy of any existing controls, and deciding whether or not the biorisk(s) is acceptable.8 Biorisk-management (bio

44、logical risk- management) The systematic analysis of strategies and methods that is performed in order to minimize the likelihood of a biosecurity or biosafety incident. The process places responsibility on the facility and its manager to demonstrate that appropriate and valid biorisk reduction proc

45、edures have been established and implemented.9Biosafety (biological safety) The application of combinations of laboratory practices and procedures, laboratory function and design, safety equipment, and appropriate occupational health programs when working with potentially infectious microorganisms a

46、nd other biohazards.Biosafety practices and procedures are designed to reduce the exposure of laboratory personnel, the public, agriculture, and the environment to potentially infectious agents and other biological hazards. The key principles of biosafety are risk assessment and containment. Biosafe

47、ty also refers to the development and implementation of administrative policies to prevent the transmission of potentially harmful biologic AMERICAN NATIONAL STANDARD Z9.14-2014 5 agents to workers, other persons, and the environment. Biosafety level (BSL) The combination of laboratory practices and

48、 techniques, safety equipment, and laboratory facilities appropriate for the operations performed and the hazards posed by the infectious agents and the laboratory function or activity. Biosafety levels are described in the BMBL.1Biosafety level 3 (BSL-3) A level of laboratory containment applicable

49、 to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures.1Biosafety professional/Biological safety officer (BSO) An individual who identifie