ANSI/AAMI ST67:2011
`
`Sterilization of health care
`products-Requirements and
`guidance for selecting a sterility
`assurance level (SAL) for products
`labeled "sterile"
`
`-
`
`Novartis Exhibit 2187.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Objectives and uses of AAM I standards and
`recommended practices
`
`It is most important that the objectives and potential uses of an
`AAMI product standard or recommended practice are clearly
`understood. The objectives of AAMI's technical development
`program derive from AAMI's overall mission: the advancement of
`medical instrumentation. Essential to such advancement are ( 1) a
`continued increase in the safe and effective application of current
`technologies to patient care, and (2) the encouragement of new
`technologies. It is AAMI's view that standards and recommended
`practices can contribute significantly to
`the advancement of
`medical instrumentation, provided that they are drafted with
`attention to
`these objectives and provided that arbitrary and
`restrictive uses are avoided.
`A voluntary standard for a medical device recommends to the
`manufacturer the information that should be provided with or on
`the product, basic safety and performance criteria that should be
`considered in qualifying the device for clinical use, and the
`measurement techniques that can be used to determine whether the
`device conforms with the safety and performance criteria and/or to
`compare the performance characteristics of different products.
`Some standards emphasize the information that should be provided
`with the device, including performance characteristics, instructions
`for use, warnings and precautions, and other data considered
`important in ensuring the safe and effective use of the device in the
`clinical
`environment. Recommending
`the
`disclosure
`of
`performance characteristics often necessitates the development of
`specialized test methods to facilitate uniformity in reporting;
`reaching consensus on these tests can represent a considerable part
`of committee work. When a drafting committee determines that
`clinical concerns warrant the establishment of minimum safety and
`performance criteria, referee tests must be provided and the reasons
`for establishing the criteria must be documented in the rationale.
`A recommended practice provides guidelines for the use, care,
`and/or processing of a medical device or system. A recommended
`practice does not address device performance per se, but rather
`procedures and practices that will help ensure that a device is used
`safely and effectively and that its performance will be maintained.
`Although a device standard is primarily directed to the
`manufacturer, it may also be of value to the potential purchaser or
`user of the device as a frame of reference for device evaluation.
`Similarly, even though a recommended practice is usually oriented
`towards healthcare professionals,
`it may be useful
`to
`the
`manufacturer in better understanding the environment in which a
`medical device will be used. Also, some recommended practices,
`while not addressing device performance criteria, provide
`guidelines to industrial personnel on such subjects as sterilization
`processing, methods of collecting data to establish safety and
`efficacy, human engineering, and other processing or evaluation
`techniques; such guidelines may be useful
`to health care
`professionals in understanding industrial practices.
`In determining whether an AAMI standard or recommended
`practice is relevant to the specific needs of a potential user of the
`document, several important concepts must be recognized:
`All AAMI standards and recommended practices are voluntary
`(unless, of course, they are adopted by government regulatory or
`procurement authorities). The application of a standard or
`recommended practice
`is solely within
`the discretion and
`professional judgment of the user of the document.
`
`Each AAMI standard or recommended practice reflects the
`collective expertise of a committee of health care professionals and
`industrial
`representatives, whose work has been
`reviewed
`nationally (and sometimes internationally). As such, the consensus
`recommendations embodied in a standard or recommended practice
`are intended to respond to clinical needs and, ultimately, to help
`ensure patient safety. A standard or recommended practice is
`limited, however, in the sense that it responds generally to
`perceived risks and conditions that may not always be relevant to
`specific situations. A standard or recommended practice is an
`important reference in responsible decision-making, but it should
`never replace responsible decision-making.
`Despite periodic review and revision (at least once every five
`years), a standard or recommended practice is necessarily a static
`document applied to a dynamic technology. Therefore, a standards
`user must carefully review the reasons why the document was
`initially developed and the specific rationale for each of its
`provisions. This review will reveal whether the document remains
`relevant to the specific needs of the user.
`Particular care should be taken in applying a product standard
`to existing devices and equipment, and in applying a recommended
`practice to current procedures and practices. While observed or
`potential risks with existing equipment typically form the basis for
`the safety and performance criteria defined
`in a standard,
`professional judgment must be used in applying these criteria to
`existing equipment. No single source of information will serve to
`identify a particular product as "unsafe". A voluntary standard can
`be used as one resource, but the ultimate decision as to product
`safety and efficacy must take into account the specifics of its
`utilization and, of course, cost-benefit considerations. Similarly, a
`recommended practice should be analyzed in the context of the
`specific needs and resources of the individual institution or firm.
`Again, the rationale accompanying each AAMI standard and
`recommended practice is an excellent guide to the reasoning and
`data underlying its provision.
`In summary, a standard or recommended practice is truly
`useful only when it is used in conjunction with other sources of
`information and policy guidance and in the context of professional
`experience and judgment.
`
`INTERPRETATIONS OF AAMI STANDARDS
`AND RECOMMENDED PRACTICES
`
`Requests for interpretations of AAMI standards and recommended
`practices must be made in writing, to the AAMI Vice President,
`Standards Policy and Programs. An official interpretation must be
`approved by letter ballot of the originating committee and
`subsequently reviewed and approved by the AAMI Standards
`Board. The interpretation will become official and representation of
`the Association only upon exhaustion of any appeals and upon
`publication of notice of interpretation in the "Standards Monitor"
`section of the AAMI News. The Association for the Advancement
`of Medical Instrumentation disclaims responsibility for any
`characterization or explanation of a standard or recommended
`practice which has not been developed and communicated in
`accordance with this procedure and which is not published, by
`appropriate notice, as an official interpretation in the AAMI News .
`
`Licensed to Maria Maida. ANSI store order# X_774615. Downloaded 12/16/2021. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`American National Standard
`
`ANSI/MMI ST67:2011
`(Revision of ANSI/MMI ST67:2003/(R)2008)
`
`Sterilization of health care products(cid:173)
`Requirements and guidance for selecting a sterility
`assurance level (SAL) for products labeled "sterile"
`
`Developed by
`Association for the Advancement of Medical Instrumentation
`
`Approved 11 April 2011 by
`American National Standards Institute, Inc.
`
`Abstract:
`
`This standard establishes requirements and guidance for selection of an appropriate sterility
`assurance level for terminally sterilized health care products.
`
`Keywords:
`
`sterility assurance level (SAL), terminal sterilization
`
`Licensed to Maria Maida . ANSI store order# X_774615 . Downloaded 12/16/202 1. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.003
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`AAMI Standard
`
`This Association for the Advancement of Medical Instrumentation (MMI) standard implies a consensus of those
`substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect
`preclude anyone, whether they have approved the standard or not, from manufacturing , marketing, purchasing , or
`using products, processes, or procedures not conforming to the standard . MMI standards are subject to periodic
`review, and users are cautioned to obtain the latest editions.
`
`CAUTION NOTICE: This MMI standard may be revised or withdrawn at any time. MMI procedures require that
`action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication .
`Interested parties may obtain current information on all MMI standards by calling or writing MMI.
`
`All MMI standards, recommended practices, technical information reports , and other types of technical documents
`developed by MMI are voluntary, and their application is solely within the discretion and professional judgment of
`the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory
`agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules
`and regulations .
`
`Published by
`
`Association for the Advancement of Medical Instrumentation
`4301 N. Fairfax Dr., Suite 301
`Arlington , VA 22203-1633
`www.aami .org
`
`© 2011 by the Association for the Advancement of Medical Instrumentation
`
`All Rights Reserved
`
`Publication , reproduction , photocopying, storage, or transmission , electronically or otherwise, of all or any part of this
`document without the prior written permission of the Association for the Advancement of Medical Instrumentation is
`strictly prohibited by law. It is illegal under federal law (17 U.S .C. § 101, et seq.) to make copies of all or any part of
`this document (whether internally or externally) without the prior written permission of the Association for the
`Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and
`damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the
`reprint request form at www.aami .org or contact MMI , 4301 N. Fairfax Dr., Suite 301, Arlington , VA 22203-1633.
`Phone: +1-703-525-4890; Fax: +1-703-525-1067.
`
`Printed in the United States of America
`
`ISBN 1-57020-416-0
`
`Licensed to Maria Maida. ANSI store order# X_774615 . Downloaded 12/16/2021. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.004
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Contents
`
`Glossary of equivalent standards ................ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......... iv
`
`Committee representation .. ....... .. ..... .. ....... .. ..... ........... ................ ................ ................ ................ ................ ................ .. vi
`
`Foreword ..... .......... ...... .......... ...... .......... ...... .......... .. ..... ................ ................ ................ ................ ................ ................. ix
`
`Introduction .............................. .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ ...... x
`
`1 Scope ................... ........ ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... ...... 1
`
`1.1
`1.2
`
`Inclusions .. ........ .... ............ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ... 1
`Exclusions ......... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... .... ....... ..... ...... 1
`
`Page
`
`2 Normative references ....................................................................... .... ............ .... ............ .... ............ .... ............ ...... 1
`
`3 Definitions .... ........ ..... ... ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ... 1
`
`4 Determination of an appropriate SAL for a health care product to be labeled "STERILE" ........ .. ..... ......... .. ..... ....... 2
`
`4.1
`4.2
`
`General .... ..... ................ ... .... .... ..... ... .... .... ..... ... .... .... ..... ... .... .... ..... ... .... .... ..... ... .... .... ..... ... .... .... ..... ... .... .... .... 2
`Selection of an SAL for a terminal sterilization process ... ..... ......... .. ..... ............ ........ ........ ........ ........ ........ ... 2
`4.2.1
`General .......................................................................................................................................... 2
`4.2.2
`Selection based on intended use of the health care product... ... .......... ...... ................. ................. . 3
`4.2.3
`Selection based on sterilization process and/or validation method .................................... ........... 3
`4.2.4
`Selection based upon the product's inability to withstand a terminal sterilization
`process that achieves a 10·5 SAL ...... ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ... 3
`
`Annexes
`
`A Background and historical application of sterility assurance .... .... ......... ... .... ......... ... .... ......... ... .... ......... ... .... ......... . 5
`
`B Examples of terminally sterilized products and sterility assurance levels that have historically been selected ...... 6
`
`C Guidance on Performing a Risk Analysis for Selecting an SAL for a product that cannot
`be sterilized to a 10·5 SAL ...... ... .... ......... ... .... ......... ... .... ......... ... .... ......... ... .... ......... ... .... ......... ... ............ ................. . 7
`
`D Bibliography .......... ............ .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ .... ............ ...... 9
`
`Table
`
`B.1 Examples of historical sterility assurance levels for terminally sterilized products* ............. ................ ................ ... 6
`
`Figure
`
`1 Decision tree for selection of SAL for medical devices to be terminally sterilized (section 4.2) ............................ .4
`
`Licensed to Maria Maida . ANSI store order # X_774615. Downloaded 12/16/2021. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.005
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Glossary of equivalent standards
`
`International Standards adopted in the United States may include normative references to other International
`Standards. For each International Standard that has been adopted by MMI (and ANSI), the table below gives the
`corresponding U.S. designation and level of equivalency to the International Standard . NOTE: Documents are sorted
`by international designation . The code in the US column , "(R)20xx" indicates the year the document was officially
`reaffirmed by MMI. E.g., ANSI/MMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and
`published in 2002 , was reaffirmed without change in 2009.
`
`Other normatively referenced International Standards may be under consideration for U.S. adoption by MMI;
`therefore, this list should not be considered exhaustive.
`
`International designation
`IEC 60601-1 :2005
`Technical Corrigendum 1 and 2
`
`IEC 60601-1-2:2007
`IEC 60601-2-2:2009
`IEC 60601-2-4:2010
`IEC 60601-2-16:2008
`IEC 60601-2-19:2009
`IEC 60601-2-20:2009
`IEC 60601-2-21 :2009
`IEC 60601-2-24:1998
`IEC 60601-2-27:2011
`IEC 60601-2-4 7:2001
`IEC 60601-2-50:2009
`IEC 80001-1 :2010
`IEC 80601-2-30:2009 and Technical
`Corrigendum 1
`
`IEC 80601-2-58:2008
`IEC/TR 60878:2009
`IEC/TR 62296:2009
`IEC 62304:2006
`IEC/TR 62348:2006
`IEC/TR 62354:2009
`IEC 62366:2007
`IEC/TR 80002-1 :2009
`ISO 5840:2005
`ISO 7198:1998
`ISO 7199:2009
`ISO 8637:2010
`ISO 8638:2010
`ISO 10993-1 :2009
`ISO 10993-2:2006
`ISO 10993-3:2003
`ISO 10993-4:2002 and
`Amendment 1 :2006
`ISO 10993-5:2009
`ISO 10993-6:2007
`ISO 10993-7:2008
`ISO 10993-9:2009
`ISO 10993-10:2010
`ISO 10993-11 :2006
`ISO 10993-12:2007
`ISO 10993-13:2010
`ISO 10993-14:2001
`ISO 10993-15:2000
`ISO 10993-16:2010
`ISO 10993-17:2002
`ISO 10993-18:2005
`ISO/TS 10993-19:2006
`ISO/TS 10993-20:2006
`ISO 11135-1 :2007
`
`Equivalency
`U.S. designation
`ANSI/MMI ES60601-1 :2005 and ANSI/MMI Major technical variations
`ES60601-1 :2005/A2 :2010
`ANSI/MMI ES60601-1 :2005/C1 :2009 (amdt) C1 Identical to Corriqendum 1 & 2
`ANSI/MMI/IEC 60601-1-2 :2007
`Identical
`ANSI/MMI/IEC 60601-2-2 :2009
`Identical
`ANSI/MMI/IEC 60601-2-4 :2010
`Identical
`ANSI/MMI/IEC 60601-2-16:2008
`Identical
`ANSI/MMI/IEC 60601-2-19:2009
`Identical
`ANSI/MMI/IEC 60601-2-20 :2009
`Identical
`ANSI/MMI/IEC 60601-2-21 :2009
`Identical
`ANSI/MMI ID26:2004/(R)2009
`Major technical variations
`ANSI/MMI/IEC 60601-2-27:2011
`Identical
`ANSI/MMI EC38:2007
`Major technical variations
`ANSI/MMI/IEC 60601-2-50 :2009
`Identical
`ANSI/MMI/IEC 80001-1 :2010
`Identical
`ANSI/MMI/IEC 80601-2-30 :2009 and
`Identical (with inclusion)
`ANSI/MMI/IEC 80601-2-30 :2009/ C1 :2009
`C1 Identical to Corrigendum 1
`(amdt) - consolidated text
`ANSI/MMI/IEC 80601-2-58:2008
`ANSI/MMI/IEC TIR60878:2003
`ANSI/MMI/IEC TIR62296 :2009
`ANSI/MMI/IEC 62304 :2006
`ANSI/MMI/IEC TIR62348:2006
`ANSI/MMI/IEC TIR62354 :2009
`ANSI/MMI/IEC 62366:2007
`ANSI/I EC/TR 80002-1 :2009
`ANSI/MMI/ISO 5840 :2005/(R)2010
`ANSI/MMI/ISO 7198:1998/2001/(R)2010
`ANSI/MMI/ISO 7199:2009
`ANSI/MMI/ISO 8637:2010
`ANSI/MMI/ISO 8638:2010
`ANSI/MMI/ISO 10993-1 :2009
`ANSI/MMI/ISO 10993-2:2006/(R)2010
`ANSI/MMI/ISO 10993-3:2003/(R)2009
`ANSI/MMI/ISO 10993-4:2002/(R)2009 and
`Amendment 1 :2006/(R)2009
`ANSI/MMI/ISO 10993-5:2009
`ANSI/MMI/ISO 10993-6:2007/(R)2010
`ANSI/MMI/ISO 10993-7:2008
`ANSI/MMI/ISO 10993-9:2009
`ANSI/MMI/ISO 10993-10:2010
`ANSI/MMI/ISO 10993-11 :2006/(R)2010
`ANSI/MMI/ISO 10993-12:2007
`ANSI/MMI/ISO 10993-13:2010
`ANSI/MMI/ISO 10993-14:2001 /(R)2006
`ANSI/MMI/ISO 10993-15:2000/(R)2006
`ANSI/MMI/ISO 10993-16:2010
`ANSI/MMI/ISO 10993-17:2002/(R)2008
`ANSI/MMI BE83 :2006
`ANSI/MMI/ISO TIR10993-19:2006
`ANSI/MMI/ISO TIR10993-20:2006
`ANSI/MMI/ISO 11135-1 :2007
`
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Maior technical variations
`Identical
`Identical
`Identical
`
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`
`iv
`
`© 2011 Association for the Advancement of Medical Instrumentation ■ ANSI/MMI ST67:2011
`
`Licensed to Maria Maida . ANSI store order# X_774615. Downloaded 12/16/202 1. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.006
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`U.S. designation
`International designation
`ANSI/MMI/ISO TIR11 135-2:2008
`ISO/TS 11135-2:2008
`ANSI/MMI/ISO 11137-1 :2006/ R)2010
`ISO 11137-1 :2006
`ISO 11137-2:2006 (2006-08-01 corrected) ANSI/MMI/ISO 11137-2:2006
`ANSI/MMI/ISO 11137-3:2006/ R 2010
`ISO 11137-3:2006
`ANSI/MMI/ISO 11138-1 :2006/ R 2010
`ISO 11138-1 :2006
`ANSI/MMI/ISO 11138-2:2006/ R 2010
`ISO 11138-2:2006
`ANSI/MMI/ISO 11138-3:2006/ R 2010
`ISO 11138-3:2006
`ANSI/MMI/ISO 11138-4:2006/ R 2010
`ISO 11138-4:2006
`ISO 11138-5:2006
`ANSI/MMI/ISO 11138-5:2006/ R 2010
`ISO/TS 11139:2006
`ANSI/MMI/ISO 11139:2006
`ANSI/MMI/ISO 11140-1 :2005/ R 2010
`ISO 11140-1 :2005
`ANSI/MMI/ISO 11140-3:2007
`ISO 11140-3:2007
`ISO 11140-4:2007
`ANSI/MMI/ISO 11140-4:2007
`ISO 11140-5:2007
`ANSI/MMI/ISO 11140-5:2007
`ANSI/MMI/ISO 11607-1:2006/ R)2010
`ISO 11607-1 :2006
`ANSI/MMI/ISO 11607-2:2006/ R 2010
`ISO 11607-2:2006
`ANSI/MMI/ISO 11633:2009
`ISO 11663:2009
`ANSI/MMI/ISO 11737-1 :2006
`ISO 11737-1 :2006
`ANSI/MMI/ISO 11737-2:2009
`ISO 11737-2:2009
`ISO/TS 12417:2011
`ANSI/MMI/ISO TIR12417 :2011
`ANSI/MMI/ISO 13408-1 :2008
`ISO 13408-1 :2008
`ANSI/MMI/ISO 13408-2:2003
`ISO 13408-2:2003
`ISO 13408-3:2006
`ANSI/MMI/ISO 13408-3:2006
`ISO 13408-4:2005
`ANSI/MMI/ISO 13408-4:2005
`ANSI/MMI/ISO 13408-5:2006
`ISO 13408-5:2006
`ANSI/MMI/ISO 13408-6:2006
`ISO 13408-6:2006
`ANSI/MMI/ISO 13485:2003/(R 2009
`ISO 13485:2003
`ANSI/MMI/ISO 13958:2009
`ISO 13958:2009
`ANSI/MMI/ISO 13959:2009
`ISO 13959:2009
`ISO 14155:2011
`ANSI/MMI/ISO 14155:2011
`ANSI/MMI/ISO 14160:1998/(R 2008
`ISO 14160:1998
`ANSI/MMI/ISO 14161 :2009
`ISO 14161:2009
`ANSI/MMI/ISO 14708-3:2008
`ISO 14708-3:2008
`ANSI/MMI/ISO 14708-4:2008
`ISO 14708-4:2008
`ANSI/MMI /ISO 14708-5:2010
`ISO 14708-5:2010
`ANSI/MMI/ISO 14937:2009
`ISO 14937:2009
`ISO/TR 14969:2004
`ANSI/MMI/ISO TIR14969:2004
`ISO 14971 :2007
`ANSI/MMI/ISO 14971 :2007/(R 2010
`ISO 15223-1 :2007 and A 1 :2008
`ANSI/MMI/ISO 15223-1 :2007 and A 1 :2008
`ANSI/MMI/ISO 15223-2:2010
`ISO 15223-2:2010
`ANSI/MMI/ISO 15225:2010
`ISO 15225:2010
`ANSI/MMI/ISO 15674:2009
`ISO 1567 4:2009
`ANSI/MMI/ISO 15675:2009
`ISO 15675:2009
`ANSI/MMI/ISO 15882:2008
`ISO 15882:2008
`ISO 15883-1 :2006
`ANSI/MMI ST15883-1 :2009
`ISO/TR 16142:2006
`ANSI/MMI/ISO TIR16142 :2005
`ISO 17664:2004
`ANSI/MMI ST81 :2004
`ANSI/MMI/ISO 17665-1 :2006
`ISO 17665-1 :2006
`ANSI/MMI/ISO TIR17665-2:2009
`ISO/TS 17665-2:2009
`ISO 184 72:2006
`ANSI/MMI/ISO 18472:2006/(R 2010
`ANSI/MMI/ISO 19218:2005
`ISO/TS 19218:2005
`ANSI/MMI/ISO 20857 :2010
`ISO 20857:2010
`ISO 22442-1 :2007
`ANSI/MMI/ISO 22442-1 :2007
`ANSI/MMI/ISO 22442-2:2007
`ISO 22442-2 :2007
`ANSI/MMI/ISO 22442-3:2007
`ISO 22442-3:2007
`ISO 23500:2011
`ANSI/MMI/ISO 23500 :2011
`ANSI/MMI/ISO 25539-1 :2003/(R)2009 and
`ISO 25539-1 :2003 and A 1 :2005
`A 1 :2005/(R)2009
`ANSI/MMI/ISO 25539-2:2008
`ANSI/MMI/ISO 26722 :2009
`ANSI/MMI/ISO 27186 :2010
`ANSI/MMI/ISO 80369-1:2010
`ANSI/MMI/ISO 81060-1 :2007
`ANSI/MMI/ISO 81060-2:2009
`
`ISO 25539-2 :2008
`ISO 26722:2009
`ISO 27186:2010
`ISO 80369-1 :2010
`ISO 81060-1 :2007
`ISO 81060-2 :2009
`
`Equivalency
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Maior technical variations
`Identical
`Maior technical variations
`Identical (with inclusions)
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`
`Identical
`Identical
`Identical
`Identical
`Identical
`Identical
`
`© 2011 Association for the Advancement of Medical Instrumentation ■ ANSI/MMI ST67:2011
`
`V
`
`Licensed to Maria Maida . AN SI store order # X_774615. Downloaded 12/16/2021. Single user license on ly. Copying and networking prohibited.
`
`Novartis Exhibit 2187.007
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Committee representation
`
`Association for the Advancement of Medical Instrumentation
`
`AAMI Sterility Assurance Level (SAL) Working Group
`
`This standard was developed by the MMI Sterility Assurance Level (SAL) Working Group under the auspices of the
`MMI Sterilization Standards Committee. Approval of this standard does not necessarily mean that all working group
`members voted for its approval.
`
`At the time this document was published , the AAMI Sterility Assurance Level (SAL) Working Group had the
`following members:
`
`Cochairs:
`
`Members:
`
`Alternates:
`
`Trabue D. Bryans, WuXi AppTec Inc.
`Victoria M. Hitchins, PhD, FDA/CDRH
`
`Christopher Anderson , Boston Scientific Corporation
`Thomas J. Berger, PhD, Hospira Worldwide Inc.
`David J. Brodersen , Covidien
`Trabue D. Bryans, WuXi AppTec Inc.
`Brian R. Drumheller, CR Bard
`Sylvie Dufresne, PhD, TSO3 Inc.
`Niki Fidopiastis, Sterigenics International
`Naomi Gamm , St Jude Medical Inc.
`Zory R. Glaser, PhD MPH CSPDM
`Joyce M. Hansen, JM Hansen & Associates
`Victoria M. Hitchins, PhD, FDA/CDRH
`Robert Dennis Houlsby, Abbott Laboratories
`Jim Kaiser, Bausch & Lomb Inc.
`Carolyn L. Kinsley, LexaMed
`Roland C. Kippenhan , Minntech Corporation
`David Liu, Johnson & Johnson
`Ronald G. Lulich , 3M Healthcare
`Lisa N. Macdonald , Becton Dickinson & Company
`Gerald E. McDonnell , PhD, Steris Corporation
`Joseph M. Mello, Ethide Laboratories Inc.
`Gerry A. O'Dell , MS, Gerry O'Dell Consulting
`Dave Parente, NAMSA
`Manuel Saavedra, Jr., Kimberly-Clark Corporation
`Mark Seybold , Baxter Healthcare Corporation
`Ian Shorr, CareFusion
`Sopheak Srun, MPH, Quality Tech Services Inc.
`Donald Tumminelli, SPS Medical Supply Corp
`Jason Voisinet, Moog Medical Devices
`Martell Kress Winters , BS SM, Nelson Laboratories Inc.
`
`Diane Battisti , Johnson & Johnson
`Nancy Blaszko, Sterigenics International
`Kimbrell Darnell, CR Bard
`April J. Doering, St Jude Medical Inc.
`Steven J. Elliott, WuXi AppTec Inc.
`Joel R. Gorski, PhD, NAMSA
`John Grillo, PhD, Hospira Worldwide Inc.
`Sean Hanley, Boston Scientific Corporation
`Katherine E. Hill, 3M Healthcare
`John T. Ice, Covidien
`Maggie Ladd , BA BS, Kimberly-Clark Corporation
`Sharon K. Lappalainen , FDA/CDRH
`Chris Lau , LexaMed
`Antonio F Lopez, CareFusion
`John Masefield , Steris Corporation
`Jonathan Karl Olson , MA, Minntech Corporation
`Leslie A. Phillips, Bausch & Lomb Inc.
`Nancy Rakiewicz, Moog Medical Devices
`
`vi
`
`© 2011 Association for the Advancement of Medical Instrumentation ■ ANSI/MMI ST67:2011
`
`Licensed to Maria Maida . ANSI store order# X_774615. Downloaded 12/16/202 1. Single user license only. Copying and networking prohibited.
`
`Novartis Exhibit 2187.008
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Mike Sadowski, Baxter Healthcare Corporation
`Michael G. Sprague, Ethide Laboratories Inc.
`Wendy Wangsgard , PhD, Nelson Laboratories Inc.
`Cheryl Work, Becton Dickinson & Company
`Christine H. Yunker, Abbott Laboratories
`
`NOTE-Participation by federal agency representatives in the development of this technical information report does not
`constitute endorsement by the federal government or any of its agencies.
`
`At the time this document was published, the AAMI Sterilization Standards Committee had the following members:
`
`AAMI Sterilization Standards Committee
`
`Cochairs:
`
`Victoria M. Hitchins, PhD, FDA/CDRH
`Michael H. Scholla, Dupont Protection Technologies
`
`Members:
`
`Christopher Anderson , Boston Scientific Corporation
`Trabue D. Bryans, WuXi AppTec Inc.
`Peter A. Burke, PhD, Steris Corporation
`Nancy Chobin, RN CSPDM, St Barnabas Healthcare System
`Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses
`Jacqueline Daley, Association for Professionals in Infection Control
`Kimbrell Darnell, CR Bar
`Dave Dion, Cardinal Health (MP&S)
`Lisa Foster, Sterigenics lnternationa
`Joel R. Gorski, PhD, NAMSA
`Deborah A. Havlik, Hospira Worldwide Inc.
`Victoria M. Hitchins, PhD , FDA/CDRH
`Lois Atkinson Jones, MS
`Susan G. Klacik , CCSMC FCS ACE , IAHCSMM
`Byron J. Lambert, PhD, Abbott Laboratories
`Colleen Patricia Landers, RN , Canadian Standards Association
`Lisa N. Macdonald , Becton Dickinson & Company
`Jeff Martin , Alcon Laboratories Inc.
`Patrick J. McCormick, PhD, Bausch & Lomb Inc.
`Rainer Newman , Johnson & Johnson
`Janet M. Prust, 3M Healthcare
`Nancy Rakiewicz, Moog Medical Devices
`Michael H. Scholla, Dupont Protection Technologies
`Mark Seybold , Baxter Healthcare Corporation
`Andrew Sharavara , PhD, Propper Manufacturing Co Inc.
`Mark N. Smith , Getinge USA
`William N. Thompson, Covidien
`Martell Kress Winters , BS SM, Nelson Laboratories Inc.
`William E. Young , (Independent Expert)
`
`Alternates:
`
`Lloyd Brown , Covidien
`Glenn W . Calvert, Becton Dickinson & Company
`Steven J. Elliott, WuXi AppTec Inc.
`Thomas J. Frazar, Johnson & Johnson
`Kathy Hoffman , Sterigenics International
`Jim Kaiser, Bausch & Lomb Inc.
`Natalie Lind , IAHCSMM
`Reynaldo Lopez, Cardinal Health (MP&S)
`Ralph Makinen , Boston Scientific Corporation
`Mary S. Mayo, CR Bard
`David Ford McGoldrick, BS, Abbott Laboratories
`James B. Neher, MS RAC , NAMSA
`Jerry R. Nelson, PhD , Nelson Laboratories Inc.
`Karen Polkinghorne, Dupont Protection Technologies
`Wallace E. Puckett, PhD, Steris Corporation
`
`© 2011 Association for the Advancement of Medical Instrumentation ■ ANSI/MMI ST67:2011
`
`vii
`
`Licensed to Maria Maida . ANSI store order# X_774615 . Downloaded 12/16/2021. Single user license only. Copying and networking prohibited .
`
`Novartis Exhibit 2187.009
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Mike Sadowski , Baxter Healthcare Corporation
`Jason Voisinet, Moog Medical Devices
`Craig A. Wallace, 3M Healthcare
`Valerie Welter, Hospira Worldwide Inc.
`
`NOTE-Participation by federal agency representatives in the development of this technical information report does not
`constitute endorsement by the federal government or any of its agencies.
`
`viii
`
`© 2011 Association for the Advancement of Medical Instrumentation ■ ANSI/MMI ST67:2011
`
`Licensed to Maria Maida . ANSI store order# X_774615. Downloaded 12/16/202 1. Single user license only. Copying and networking prohibited .
`
`Novartis Exhibit 2187.0010
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Foreword
`
`This standard was developed by the MMI Sterility Assurance Level (SAL) Working Group (formerly the
`Microbiological Quality [SALs] of Processed Medical Devices Working Group) under the auspices of the MMI
`Sterilization Standards Committee.
`
`The purpose of this standard is to codify current North American sterilization practices and provide a standardized
`framework for determining appropriate SALs.
`
`While the 2003 edition of ANSI/MMI ST67 was very restrictive in what was required for supportin~ the use of SALs
`, this updated version allows manufacturers to select an alternate SAL, such as 10- or 10-4
`other than 10-6
`, for those
`types of products that are sensitive to 1 o-6 sterilization processes. The revised standard requires the use of the most
`rigorous SAL that the product can withstand, as well as a risk assessment in order to select an alternate SAL. This
`focus on risk assessment aligns with other regulatory documents.
`
`As used within the context of this standard , "shall" indicates requirements strictly to be followed in order to conform
`to the standard ; "should" indicates that among several possibilities one is recommended as particularly suitable,
`without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required , or
`that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited ; "may" is
`used to indicate that a course of action is permissible within the limits of the standard ; and "can" is used as a
`statement of possibility and capability. "Must" is used only to describe "unavoidable" situations, including those
`mandated by government regulation .
`
`MMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect
`technological advances that may have occurred since publication .
`
`The concepts incorporated in this standard should be c onsidered flexible and dy namic. MMI policies and
`procedures require that MMI standards and recommended practices be reviewed and , if necessary, revised at least
`once every five years. To remain relevant, it must be modified as technological advances are made and as new data
`comes to light.
`
`Suggestions for improving this standard are invited . Comments and suggested revisions should be sent to Technical
`Programs, MMI, 4301 N. Fairfax Drive, Suite 301 , Arlington , VA 22203-1633.
`
`NOTE-This foreword does not contain provisions of the MMI standard Sterilization of medical devices-Requirements
`for products labeled "sterile" (ANSI/MMI ST67:2011 ), but it does provide important information about the development
`and intended use of th