36C25618Q0343-002.pdf

Association for the Advancement of Medical Instrumentation

ANSI/AAMI ST79:2010 & A1:2010

(Consolidated Text)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Vanessa Towers, BSN / Progressive Surgical Solutions LLC AAMI Order # 111133 / Order Date: 06/15/2011 Single-user license only. Copying, networking, and distribution prohibited.

Objectives and uses of AAMI 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.

American National Standard ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text)

(Revision of ANSI/AAMI ST79:2006 and A1:2008 & A2:2009)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Developed by Association for the Advancement of Medical Instrumentation

Approved 4 August 2010 by Amendment 1 Approved 24 September 2010 by American National Standards Institute Inc.

Abstract: This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures;

installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.

Keywords: ambulatory care facilities, cleaning, continuous quality improvement, decontamination, dental office, flash sterilization, moist heat sterilization, packaging, quality control, quality system, saturated steam, sterile storage, sterilization containers, surgical instruments, table-top sterilizers

AAMI Recommended Practice

This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have approved the recommended practice or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions.

CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this recommended practice no later than five years from the date of publication. Interested parties can obtain current information on all AAMI documents by calling or writing AAMI.

All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI 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

© 2010 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 AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067.

Printed in the United States of America

ISBN 1–57020–389–X

Single-user license only. Copying, networking, and distribution prohibited.

http://www.aami.org/ http://www.aami.org/

Contents

Glossary of equivalent standards .............................................................................................................................ix

Committee representation ........................................................................................................................................xi

Acknowledgments .................................................................................................................................................. xiii

Foreword ................................................................................................................................................................ xiv

Introduction: Need for the recommended practice

1 Scope

1.1 General

1.2 Inclusions

1.3 Exclusions

2 Definitions and abbreviations

3 Design considerations

3.1 General rationale

3.2 Work area design and functional workflow

3.2.1 Definitions of work areas

3.2.2 Design criteria

3.2.3 Functional workflow patterns

3.2.4 Traffic control

3.3 Physical facilities

3.3.1 Space requirements

3.3.2 Mechanical systems

3.3.3 Electrical systems

3.3.4 Steam for sterile processing

3.3.5 Utility monitoring and alarm systems

3.3.6 General area requirements

3.3.7 Special area requirements and restrictions

3.3.8 Emergency eyewash/shower equipment

3.4 Housekeeping procedures

4 Personnel considerations

4.1 General rationale

4.2 Qualifications

4.2.1 Supervisory personnel

4.2.2 Sterile processing personnel

4.3 Training and continuing education

4.3.1 Sterile processing personnel

4.3.2 Service personnel

4.3.3 Other personnel

4.4 Health and personal hygiene

4.5 Attire

4.5.1 General considerations

4.5.2 Decontamination area

4.5.3 Sterilization area (flash sterilization)

4.5.4 Service personnel

4.6 Standard/transmission-based (enhanced) precautions

5 Receiving

5.1 General rationale

5.2 Receiving of purchased or loaner items

5.2.1 General considerations

5.2.2 Newly purchased reusable items and repaired reusable items

5.2.3 Rigid sterilization container systems

5.2.4 Disposable items

5.3 Disposition of sterile items (issued but not used)

6 Handling, collection, and transport of contaminated items

6.1 General rationale

6.2 Separation of waste and reusable items at point of use

6.3 Care and handling of contaminated reusable items at point of use

6.4 Containment

6.5 Transport

6.5.1 Segregation of clean/sterile items

6.5.2 Transportation scheduling and routes

6.5.3 Transportation equipment

6.5.4 Hand transport

6.5.5 Dedicated lifts

6.5.6 Transport between buildings

6.5.7 Off-site transportation

7 Cleaning and other decontamination processes

7.1 General rationale

7.2 Policies, procedures, and manufacturers’ instructions

7.2.1 Policies and procedures

7.2.2 Manufacturers’ instructions

7.3 Presoaking

7.4 Disassembly

7.4.1 Sorting and disassembly of instrumentation

7.4.2 Disassembly of rigid sterilization container systems

7.5 Cleaning

7.5.1 General considerations

7.5.2 Cleaning agents

7.5.3 Methods of cleaning

7.5.4 Rinsing

7.5.5 Verification of the cleaning process

7.5.6 Cleaning of instruments

7.5.7 Utensils

7.5.8 Reusable textiles

7.5.9 Rigid sterilization container systems

7.6 Microbicidal processes

7.6.1 General considerations

7.6.2 Processes to decontaminate devices so that they are safe to handle

7.6.3 Terminal sterilization processes to prepare devices for the next patient use

7.7 Servicing and repair of devices in the health care facility

7.7.1 General considerations

7.7.2 Potential for exposure

7.7.3 Protective measures for service personnel

7.7.4 Postexposure program

7.7.5 Devices that cannot be repaired in-house

8 Packaging, preparation, and sterilization

8.1 General rationale

8.2 Selection of packaging materials

8.3 Package configurations and preparation

8.3.1 General considerations

8.3.2 Package labels

8.3.3 Package closures

8.3.4 Paper–plastic pouches

8.3.5 Textile packs

8.3.6 Basins and basin sets

8.3.7 Surgical supplies

8.3.8 Devices with lumens

8.4 Preparation and assembly of surgical instrumentation

8.4.1 General considerations

8.4.2 Weight and density of sets

8.4.3 Inspection

8.4.4 Instrument placement

8.4.5 Use of tray liners or containment devices

8.5 Loading the sterilizer

8.5.1 General considerations

8.5.2 Paper–plastic pouches

8.5.3 Instrument sets

8.5.4 Textile packs

8.5.5 Utensils and glassware

8.5.6 Rigid sterilization container systems

8.5.7 Liquids and solutions

8.5.8 Powders and oils

8.6 Sterilization parameters

8.6.1 Sterilization parameters for wrapped or containerized items

8.6.2 Flash sterilization parameters

8.6.3 Specialty instruments

8.7 Monitoring sterilization cycles

8.8 Unloading the sterilizer

8.8.1 Large-chamber sterilizers

8.8.2 Table-top sterilizers

8.8.3 Open-tray flash cycles

8.8.4 Flash cycles with single wrappers or other textile packaging

8.8.5 Flash cycles with sealed containment devices

8.8.6 Handling and inspection

8.9 Sterile storage

8.9.1 Sterility maintenance covers

8.9.2 Storage facilities

8.9.3 Shelf life

8.10 Distribution (general)

8.10.1 Handling and inspection

8.10.2 Distribution containers

8.11 Transport of sterile packaged items

8.11.1 General considerations

8.11.2 Tables and carts (open or closed)

8.11.3 Hand transport

8.11.4 Dedicated lifts

8.11.5 Off-site transportation

8.11.6 Policies and procedures

8.12 Aseptic presentation

8.12.1 Opening sterile packages

8.12.2 Removing items from sterile packaging and transferring them to the sterile field

9 Installation, care, and maintenance of sterilizers

9.1 General rationale

9.2 Instruction manuals

9.3 Installation

9.4 Routine care

9.5 Preventive maintenance

9.5.1 General considerations

9.5.2 Scheduled maintenance

9.6 Calibration

9.7 Record-keeping

10 Quality control

10.1 General rationale

10.2 Monitoring of mechanical cleaning equipment

10.3 Product identification and traceability

10.3.1 Lot control numbers

10.3.2 Sterilizer records

10.3.3 Expiration dating

10.4 Overview of sterilization process monitoring

10.5 Sterilization process monitoring devices

10.5.1 Physical monitors

10.5.2 Chemical indicators (CIs)

10.5.3 Biological indicators

10.5.4 Process challenge devices (PCDs)

10.6 Routine load release

10.6.1 Process monitoring devices

10.6.2 Release criteria for nonimplants

10.6.3 Release criteria for implants

10.6.4 Sterilization process failures

10.7 Routine sterilizer efficacy monitoring

10.7.1 General considerations

10.7.2 Routine biological monitoring of sterilizers larger than 2 cubic feet

10.7.3 Routine biological monitoring of table-top sterilizers

10.7.4 Routine biological monitoring of flash sterilization cycles

10.7.5 Actions to be taken when biological indicators, chemical indicators, or physical monitors indicate failure

10.7.6 Routine Bowie-Dick testing of dynamic-air-removal sterilizers

10.8 Qualification testing

10.8.1 General considerations

10.8.2 Qualification testing of sterilizers larger than 2 cubic feet

10.8.3 Qualification testing of table-top sterilizers

10.8.4 Qualification testing of flash sterilization cycles

10.9 Periodic product quality assurance testing of routinely processed items

10.10 Periodic product quality assurance testing of rigid sterilization container systems

10.10.1 General considerations

10.10.2 Responsibilities of the manufacturer

10.10.3 User responsibilities

10.11 Product recalls

10.11.1 General considerations

10.11.2 Recall procedure

10.11.3 Recall order

10.11.4 Recall report

11 Quality process improvement

11.1 General rationale

11.2 Quality process

11.2.1 General considerations

11.2.2 Risk analysis

11.2.3 Decontamination

11.2.4 Rigid sterilization container systems

11.2.5 Flash sterilization

11.3 Functional areas for product and process improvements

11.3.1 Workplace design

11.3.2 Processing policies and procedures

11.3.3 Product use

11.4 Implementing product and process improvements

12 New product evaluation

12.1 General rationale

12.2 Considerations

Annexes A Examples of workplace design

B Infection transmission

C Processing CJD-contaminated patient care equipment and environmental surfaces

D User verification of cleaning processes

E Selection and use of chemical disinfectants

F Thermal disinfection

G Devices returned to the manufacturer

H Occupational exposure to blood-borne pathogens (29 CFR Part 1910.1030)

I Development of a prepurchase evaluation protocol for rigid sterilization container systems

J Effect of containerized packaging on load heat-up time

K Development and qualification of the 16 towel PCD (biological-indicator challenge test pack)

L Example of documentation of premature release of implants

M Steam quality

N Toxic anterior segment syndrome (TASS) and the processing of intraocular surgical instruments

O Bibliography

Tables

1 Saturated steam pressure conversion units at sea level

2 Ventilation requirements for functional areas

3 IES-recommended illuminance levels for work environments

4 Minimum cycle times for gravity-displacement steam sterilization cycles

5 Minimum cycle times for dynamic-air-removal steam sterilization cycles

6 Sterilization process monitoring recommendations

7 Types and applications for use of sterilization monitoring devices

8 Checklist for identifying reasons for steam sterilization process failures

9 Summary of test configurations for prepurchase evaluation of rigid sterilization container systems

D.1 In-use tests available to assess efficacy of cleaning of medical devices

D.2 In-use tests available to assess efficacy of washer-disinfectors used for medical device reprocessing

E.1 Levels of disinfection according to type of microorganism

E.2 Occupational exposure limits for some chemical sterilants and disinfectants

K.1 16 towel pack survey

K.2 Biological-indicator results from 121ºC (250ºF) gravity cycle

K.3 Biological-indicator results from 132ºC (270ºF) deep-vacuum cycle

K.4 Biological-indicator results from 132ºC (270ºF) pulsing vacuum cycle

K.5 Comparison of the 16 towel pack with the 12 12 20 inch pack by Most Probable Number and sterility assessment of spore strips (121ºC [250ºF] gravity cycle)

K.6 Fraction-negative results in a 121ºC (250ºF) gravity cycle

K.7 Biological-indicator results from121ºC (250ºF) steam-flush pressure-pulse cycle

K.8 Biological-indicator results from 132ºC (270ºF) steam-flush pressure-pulse cycle

Figures

1 Functional work areas of a sterile processing department

2 Workflow

3 Microbicidal processes and use of PPE

4 Sequential double-wrapping: envelope fold

5 Sequential double-wrapping: square fold

6 Simultaneous double-wrapping: envelope fold

7 Simultaneous double-wrapping: square fold

8 Example of single- and double-packaging with paper–plastic pouches

9 Loading the sterilizer

10 Preparation of the 16 towel PCD (BI challenge test pack)

11 Placement of the 16 towel PCD (BI challenge test pack) for routine biological monitoring of sterilizers larger than 2 cubic feet

12 Decision tree for conducting investigations of steam sterilization process failures

13 Composition of the Bowie-Dick test pack

14 Placement of the Bowie-Dick test pack

15 Placement of the 16 towel PCD (BI challenge test pack) for qualification testing

A.1 Example of a work area design and workflow pattern for a sterile processing department in a typical small hospital

A.2 Example of a work area design and workflow pattern for a sterile processing department in a typical medium-sized hospital

A.3 Example of a work area design and workflow pattern for a sterile processing department in a typical regional processing center

A.4 Example of a work area design and workflow pattern for a sterile processing department

A.5 Example of a work area design and workflow pattern for a sterile processing department

A.6 Example of a work area design and workflow pattern for a sterile processing department

A.7 Example of an ambulatory surgery facility

A.8 Example of a dental facility

B.1 The chain of infection, components of the infectious disease process

B.2 Blood-borne pathogen strike-through conversion chart

J.1 Typical rigid sterilization container system processed in a gravity-displacement cycle at 121ºC (250ºF)

J.2 Muslin-wrapped, 16-pound instrument set processed in a gravity-displacement cycle at 121ºC (250ºF)

J.3 Typical rigid sterilization container system processed in a prevacuum cycle at 132ºC (270ºF)

K.1 Temperature profiles for two different configurations of 12 12 20 inch packs in a 121ºC (250ºF) gravity cycle

K.2 Temperature profiles for huck and absorbent 16 towel packs in a 121ºC (250ºF) gravity cycle

K.3 Average temperature profile for the 16 towel pack in a 121ºC (250ºF) gravity cycle

L.1 Implantable devices load record

L.2 Exception form for premature release of implantable device/tray

© 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 ix

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 AAMI (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 AAMI. E.g., ANSI/AAMI/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 AAMI;

therefore, this list should not be considered exhaustive.

International designation U.S. designation Equivalency

IEC 60601-1:2005

Technical Corrigendum 1 and 2

ANSI/AAMI ES60601-1:2005 and ANSI/AAMI

ES60601-1:2005/A2:2010

ANSI/AAMI ES60601-1:2005/C1:2009 (amdt)

Major technical variations

C1 Identical to Corrigendum 1 & 2

IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003/(R)2010 Major technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 and Technical Corrigendum 1

ANSI/AAMI/IEC 80601-2-30:2009 and

ANSI/AAMI/IEC 80601-2-30:2009/ C1:2009

(amdt) – consolidated text

Identical (with inclusion) C1 Identical to Corrigendum 1

IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006 ANSI/AAMI/IEC TIR62348:2006 Identical IEC/TR 62354:2009 ANSI/AAMI/IEC TIR62354:2009 Identical IEC/TR 80002-1:2009 ANSI/IEC/TR 80002-1:2009 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005/(R)2010 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 Identical ISO 8637:2010 ANSI/AAMI/ISO 8637:2010 Identical ISO 8638:2010 ANSI/AAMI/ISO 8638:2010 Identical ISO 10993-1:2009 ANSI/AAMI/ISO 10993-1:2009 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Identical ISO 10993-4:2002 and Amendment 1:2006

ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009

Identical

ISO 10993-5:2009 ANSI/AAMI/ISO 10993-5:2009 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:2009 ANSI/AAMI/ISO 10993-9:2009 Identical ISO 10993-10:2002 and Amendment 1:2006

ANSI/AAMI BE78:2002/(R)2008

ANSI/AAMI BE78:2002/A1:2006/(R)2008

Minor technical variations Identical

ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:2010 ANSI/AAMI/ISO 10993-16:2010 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002/(R)2008 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical x © 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010

International designation U.S. designation Equivalency ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006 ANSI/AAMI/ISO 11137-1:2006/(R)2010 Identical

ISO 11137-2:2006 (2006-08-01

corrected version)

ANSI/AAMI/ISO 11137-2:2006 Identical

ISO 11137-3:2006 ANSI/AAMI/ISO 11137-3:2006/(R)2010 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006/(R)2010 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006/(R)2010 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006/(R)2010 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006/(R)2010 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006/(R)2010 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005/(R)2010 Identical ISO 11140-3:2007 ANSI/AAMI/ISO 11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006 ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006 ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:2009 ANSI/AAMI/ISO 11737-2:2009 Identical ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical ISO 13408-2:2003 ANSI/AAMI/ISO 13408-2:2003 Identical ISO 13408-3:2006 ANSI/AAMI/ISO 13408-3:2006 Identical ISO 13408-4:2005 ANSI/AAMI/ISO 13408-4:2005 Identical ISO 13408-5:2006 ANSI/AAMI/ISO 13408-5:2006 Identical ISO 13408-6:2006 ANSI/AAMI/ISO 13408-6:2006 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003/(R)2009 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003/(R)2008 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003/(R)2008 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998/(R)2008 Identical ISO 14161:2009 ANSI/AAMI/ISO 14161:2009 Identical ISO 14708-3:2008 ANSI/AAMI/ISO 14708-3:2008 Identical ISO 14708-4:2008 ANSI/AAMI/ISO 14708-4:2008 Identical ISO 14708-5:2010 ANSI/AAMI /ISO 14708-5:2010 Identical ISO 14937:2009 ANSI/AAMI/ISO 14937:2009 Identical ISO/TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2007 ANSI/AAMI/ISO 14971:2007 Identical ISO 15223-1:2007 and A1:2008 ANSI/AAMI/ISO 15223-1:2007 and A1:2008 Identical ISO 15223-2:2010 ANSI/AAMI/ISO 15223-2:2010 Identical ISO 15225:2010 ANSI/AAMI/ISO 15225:2010 Identical ISO 15674:2009 ANSI/AAMI/ISO 15674:2009 Identical ISO 15675:2009 ANSI/AAMI/ISO 15675:2009 Identical ISO 15882:2008 ANSI/AAMI/ISO 15882:2008 Identical ISO 15883-1:2006 ANSI/AAMI ST15883-1:2009 Major technical variations ISO/TR 16142:2006 ANSI/AAMI/ISO TIR16142:2005 Identical ISO 17664:2004 ANSI/AAMI ST81:2004 Major technical variations ISO 17665-1:2006 ANSI/AAMI/ISO 17665-1:2006 Identical (with inclusions) ISO/TS 17665-2:2009 ANSI/AAMI/ISO TIR17665-2:2009 Identical ISO 18472:2006 ANSI/AAMI/ISO 18472:2006 Identical ISO/TS 19218:2005 ANSI/AAMI/ISO 19218:2005 Identical ISO 22442-1:2007 ANSI/AAMI/ISO 22442-1:2007 Identical ISO 22442-2:2007 ANSI/AAMI/ISO 22442-2:2007 Identical ISO 22442-3:2007 ANSI/AAMI/ISO 22442-3:2007 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003/(R)2009 and

A1:2005/(R)2009 Identical

ISO 25539-2:2008 ANSI/AAMI/ISO 25539-2:2008 Identical ISO 27186:2010 ANSI/AAMI/ISO 27186:2010 Identical ISO 81060-1:2007 ANSI/AAMI/ISO 81060-1:2007 Identical ISO 81060-2:2009 ANSI/AAMI/ISO 81060-2:2009 Identical

© 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 xi

Committee representation Association for the Advancement of Medical Instrumentation

Steam Sterilization Hospital Practices Working Group

This recommended practice was developed by the AAMI Steam Sterilization Hospital Practices Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the recommended practice does not necessarily mean that all working group members voted for its approval.

At the time this recommended practice was published, the AAMI Steam Sterilization Hospital Practices Working Group had the following members:

Cochairs: Ramona Conner, RN, MSN, CNOR Cynthia Spry, RN, MSN, CNOR Members: Richard Bancroft, Esq Member Steris Corporation

Ralph J. Basile, MBA Member Healthmark Ind Co Inc Nola Bayes, MBA Member Independent Expert Damien Berg Member Medical Center of the Rockies Hassan Bilal, CRCST CST Member Independent Expert Loran H. Bruso, BS MBA, Steritec Products Manufacturing Co. Inc.

Kathy M. Bury, INOVA Alexandria Hospital Bradley J. Bushman, Standard Textile Co. Inc.

Mike Carragher, Getinge USA Edward P. Casey, CSPDM, The Hospital of Central Connecticut Bradley J. Catalone, PhD, Olympus America Inc.

Harriet Chan-Myers, Johnson & Johnson David Chapman, Roche Molecular Systems Marc Chaunet, TSO3 Inc.

Nancy Chobin, RN, CSPDM, St. Barnabas Health Care System Ramona Conner, RN, MSN, CNOR, Association of Perioperative Registered Nurses Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology Diana Davis, Brunswick Community Hospital Michele Dawn Demeo, CRCST, CSPDT, Memorial Hospital Shawn A. Doyle, Sterilator Company Inc.

Mark Duro, New England Baptist Hospital Betty D. Edge, Northshore University Hospital Rosie Fardo, RN, BSN, CIC, CHSP, Department of Veterans Affairs Medical Center Jeff Felgar, Zimmer Inc.

Marcia Ann Frieze, Case Medical Inc.

Charles Oren Hancock, RAC, H&W Technology LLC Barbara Ann Harmer, RN, BSN, MHA Jennifer Harte, DDS, MS, American Dental Association Rachel Hill, CareFusion Charles A. Hughes, SPS Medical Supply Corp David M. Jagrosse, Middlesex Hospital Nupur Jain, Stryker Instruments Division Nyla Skee Japp, PhD, RN, CSPDM, Integrated Medical Systems David W. Johnson, Kimberly-Clark Corporation Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare Central Service

Materiel Management Colleen Patricia Landers, RN, Canadian Standards Association Mary Kneece Lane, BS, MHA, CSPDS, CSPDM, The Medical University of South Carolina Angela M. Lewellyn, LPN, CSPDT, CRCST, Advantage Support Services, Inc.

Chris Mannarino, Belimed Inc.

Teckla A. Maresca, LPN, CSPDM, St. Clare's Health System Ruby Martinez, Cardinal Health (MP&S) Patrick J. McCormick, PhD, Bausch & Lomb Inc.

Candace McManus, PhD, FDA/CDRH Emily Mitzel, MS, Nelson Laboratories Inc.

Thomas K. Moore Karen Nauss, CRCST, Mount Auburn Hospital Scott Pignatella xii © 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010

Janet M. Prust, 3M Healthcare Shaundrea L. Rechsteiner, NAMSA Cheron Rojo, Childrens Hospital of Central California Wendy Royalty, Raven Biological Laboratories Rose E. Seavey, RN, MBA, CNOR, CRCST, Seavey Healthcare Consulting, Inc.

Andrew Sharavara, PhD, Propper Manufacturing Co. Inc.

Frank Sizemore, Wake Forest Univeristy - Baptist Medical Center Linda Slone, RN, BSPA, CNOR Joan M. Spear, Aesculap Inc.

Cynthia Spry, RN, Independent Clinical Consultant Betty Strickland, Pryce Consultants Donna Swenson, BS, CSPDM, West Suburban Medical Center Mary Velasco, Henry Ford Macomb Hospital P. Richard Warburton, ChemDAQ Inc.

Nora E. Wikander, RN, CSPDM, St. Joseph's Wayne Hospital, Wayne, NJ

Alternates: Denise Adams, Aesculap Inc.

Richard P. Blasko, Steris Corporation Annette Bojanski, Raven Biological Laboratories Laureen C. Clark, M.T., Kimberly-Clark Corporation Linda Clement, CRCST, Steris Corporation Julie M. Conyer, Bausch & Lomb Inc.

Susan Flynn, 3M Healthcare Joel R. Gorski, PhD, NAMSA Thomas Grobaski, Belimed Inc.

Peter Hudnut, Getinge USA Danny Hutson, CareFusion Stephen M. Kovach, Healthmark Ind Co. Inc.

Natalie Lind, International Association of Healthcare Central Service Materiel Management Tania Lupu, Case Medical Inc.

Sheila A. Murphey, FDA/CDRH Charles D. Paige, Department of Veterans Affairs National Center for Patient Safety Mahesh Patel, Propper Manufacturing Co. Inc.

Jason Pope, Nelson Laboratories Inc.

Elizabeth A. Riegel, FDA/CDRH Kristen Singleton, PhD, Steritec Products Manufacturing Co. Inc.

Gary J. Socola, SPS Medical Supply Corp.

R. Brent Sweet, Zimmer Inc.

Raymond Taurasi, Healthmark Ind. Co. Inc.

Jeff Teeter, CareFusion Martha Young, 3M Healthcare

NOTE—Participation by federal agency representatives in the development of this recommended practice does not constitute endorsement by the federal government or any of its agencies.

AAMI Sterilization Standards Committee

Cochairs: Victoria M. Hitchins, PhD William E. Young

Members: Trabue D. Bryans, WuXi AppTec Peter A. Burke, PhD, Steris Corporation Nancy Chobin, RN, CSPDM, St. Barnabas Health Care System Charles Cogdill, Boston Scientific Corporation Ramona Conner, RN, MSN, CNOR, Association of Perioperative Registered Nurses Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology Kimbrell Darnell, CR Bard Dave Dion, Cardinal Health (MP&S) Lisa Foster, Sterigenics International Joel R. Gorski, PhD, NAMSA Deborah A. Havlik, Hospira Worldwide Inc.

Victoria M. Hitchins, PhD, FDA/CDRH Lois Atkinson Jones, MS

© 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 xiii

Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare Central Service Materiel Management

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, Ethox International Inc.

Michael H. Scholla, Dupont Nonwovens Mark Seybold, Baxter Healthcare Corporation Andrew Sharavara, PhD, Propper Manufacturing Co. Inc.

Mark N. Smith, Getinge USA William N. Thompson, Covidien James L. Whitby, MA, MB, FRCPt Martell Kress Winters, BS, SM, Nelson Laboratories Inc.

William E. Young

Alternates: Lloyd Brown, Covidien Glenn W. Calvert, Becton Dickinson & Company Steven J. Elliott, WuXi AppTec Thomas J. Frazar, Johnson & Johnson Kathy Hoffman, Sterigenics International Jim Kaiser, Bausch & Lomb Inc.

Joseph J. Lasich, BS, Alcon Laboratories Inc.

Natalie Lind, International Association of Healthcare Central Service Materiel Management Reynaldo Lopez, Cardinal Health (MP&S) Ralph Makinen, Boston Scientific Corporation Mary S. Mayo, CR Bard David Ford McGoldrick, BS, Abbott Laboratories Jerry R. Nelson, PhD, Nelson Laboratories Inc.

Karen Polkinghorne, Dupont Nonwovens Mike Sadowski, Baxter Healthcare Corporation John R. Scoville, Jr., Steris Corporation Jason Voisinet, Ethox International Inc.

Craig A. Wallace, 3M Healthcare Valerie Welter, Hospira Worldwide Inc.

NOTE—Participation by federal agency representatives in the development of this recommended practice does not constitute endorsement by the federal government or any of its agencies.

Acknowledgments The AAMI Steam Sterilization Hospital Practices Working Group gratefully acknowledges the important contributions of both current and former Working Group members, who have been instrumental in preparing the first edition of this document, the 2008 and 2009 amendments, and this editorial revision, which offers users a comprehensive document on steam sterilization practices. The continuous maintenance process, which keeps this document current, demands a great deal of Working Group members' time, and all involved have willingly donated their time and expertise. The Working Group also gratefully acknowledges Judy Veale, the AAMI staff liaison who was invaluable in keeping this document, and the Working Group, on track through the amendment and revision process.

Foreword This recommended practice was developed by the Steam Sterilization Hospital Practices Working Group of the AAMI Sterilization Standards Committee. The purpose of the guidelines in this document is to help ensure the steam sterilization of products in health care facilities and the maintenance of the sterility of processed items until the point of use.

To facilitate user access to all AAMI consensus recommendations for steam sterilization in health care facilities, the first edition of ANSI/AAMI ST79, published in 2006, consolidated into one comprehensive guide the following AAMI recommended practices:

ANSI/AAMI ST46, Steam sterilization and sterility assurance in health care facilities

ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities

ANSI/AAMI ST37, Flash sterilization: Steam sterilization of patient care items for immediate use

ANSI/AAMI ST35, Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings

ANSI/AAMI ST33, Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities

In the course of the consolidation process, the five recommended practices listed above were updated and revised to reflect current good practice, and several annexes were added to provide additional information to users. The recommended practice serves as a comprehensive guideline for all steam sterilization activities in health care facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all health care personnel who use steam for sterilization.

In 2008 and 2009, numerous amendments of the document were adopted as part of the AAMI continuous maintenance process. These amendments addressed such topics as toxic anterior segment syndrome (TASS), paper plastic pouches, steam quality, devices with lumens, chemical indicators, sterilization process failures, product families, evaluation of sterilization container systems, risk analysis, and verification of cleaning. This second edition of ANSI/AAMI ST79 incorporates these amendments, as well as additional changes in the provisions regarding steam quality. In addition, the document reflects general editorial revisions (e.g., updating of references).

This recommended practice reflects the conscientious efforts of health care professionals, in cooperation with medical device and equipment manufacturers, to develop recommendations for optimum performance levels in the processing of reusable medical devices to be steam sterilized. It is not intended that these recommendations be construed as universally applicable in all circumstances. Also, it is recognized that in many cases these recommendations might not be immediately achievable. Therefore, the document should be used to guide personnel towards desirable performance objectives, and all of its provisions should be considered and applied in the light of professional judgment and experience.

As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the recommended practice. “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 recommended practice. “Can” is used as a statement of possibility and capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated by government regulation.

The provisions of this recommended practice should be reviewed routinely by departmental managers and adapted to the needs of their particular institutions. Written policies and procedures should be developed and implemented in consultation with appropriate hospital committees (e.g., safety, infection prevention and control, and hazardous materials).

The concepts incorporated in this recommended practice should be considered flexible and dynamic. The recommendations set forth in this document are reviewed and updated periodically to assimilate progressive technological developments. AAMI policies and procedures require that AAMI standards and recommended practices be reviewed and, if necessary, revised at least once every five years.

xiv © 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010

© 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 xv

This standard is maintained under continuous maintenance procedures. AAMI has created a notification registry that will send e-mail announcements when any maintenance activity occurs to the recommended practice. To register, visit http://www.aami.org/standards/st79.registry.html. Suggestions for improving this recommended practice are invited. Comments or proposals for revisions to any part of the standard may be submitted to AAMI at any time. Written comments are to be sent to: Standards Dept., AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Comments may also be e-mailed to: standards@aami.org.

NOTE—This foreword does not contain provisions of the AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79 and ST79/A1), but it does provide important information about the development and intended use of the document.

xvi © 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010

AAMI Recommended Practice ANSI/AAMI ST79:2010 & A1:2010

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Introduction: Need for the recommended practice Overview:

Saturated steam under pressure is one of the oldest methods used in health care facilities to sterilize medical devices. Because this method has been available for so many years, it is thought to be a simple process, one that is well understood and controlled. However, the efficacy of any sterilization process, including saturated steam, depends on a consistent system for lowering and limiting bioburden before sterilization, properly preparing items for sterilization, selecting the appropriate sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used. These four phases are critically interdependent, and each must be accomplished to produce and maintain a sterile product.

The delivery of sterile health care products for use in patient care depends not only on the efficacy of the sterilization process itself but also on the following factors:

a) efficient facility design,

b) proper training of personnel,

c) good infection prevention and control practices designed to prevent health-care-associated infections,

d) effective quality control and process improvement systems that encompass all aspects of device reprocessing from point of use through sterilization to reuse, and

e) appropriate documentation and reporting practices that enable traceability of each facility-sterilized medical device to the patient on whom it was used.

Health care facilities differ in their physical design and equipment and in the level of personnel expertise, competence, and training. This recommended practice has been developed to set forth guidelines for facility design, work practices, and process controls that will help ensure that sterile items are consistently produced using saturated steam under pressure.

This recommended practice addresses elements of a quality system, but it is not intended to provide comprehensive guidance on this subject.

Many of the activities that affect sterilization processing occur in areas separate from the location where sterilization is actually carried out. Therefore, the policies and procedures governing sterilization processing should be developed in consultation with the managers of areas that use sterile medical devices and with appropriate committees or functional groups within the facility (e.g., infection prevention and control, safety, hazardous materials, risk management). In addition, the support of the facility’s administration is vital, especially in those facilities where the establishment of a quality system to implement steam sterilization process validation and parametric release is being considered.

It might not be possible for a health care facility to implement all the provisions of this recommended practice because of environmental restrictions and/or limitations in capital funding. However, it is recommended that the health care facility’s administration be made aware of any current deficiencies so that the allocation of needed resources can be planned.

This recommended practice encompasses steam sterilization in all health care facilities, including ambulatory-care and office-based facilities. It covers steam sterilization by both the wrapped and unwrapped (flash) methods and provides detailed guidance on decontamination and packaging, with special reference to rigid sterilization container systems.

© 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 1

Steam sterilization in office-based, ambulatory-care medical, surgical, and dental facilities:

Advances in medical, surgical, and dental practice have led to the increased use of alternative health care sites, such as offices, ambulatory-care clinics, and similar clinical settings; many such facilities use small table-top steam sterilizers. Office-based practices can differ greatly from hospitals in their physical design and in the training level of personnel. The general concepts in this recommended practice apply to these settings. In some sections, processes or equipment used most frequently within the office-based and ambulatory setting are specifically addressed.

Flash sterilization:

A flash sterilization cycle is one that has been designed to meet the following criteria:

a) The cycle is preprogrammed to a specific time-temperature setting established by the manufacturer on the basis of the type of sterilizer control (i.e., gravity-displacement, dynamic-air-removal) and selected by the user on the basis of the medical device manufacturer’s written instructions and the load configuration (i.e., the presence or absence of porous materials).

b) The items to be processed are usually unwrapped, although a single wrapper may be used in certain circumstances if the sterilizer or packaging manufacturer’s written instructions permit. Some rigid sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles.

c) Because…