AAMI ST108-2023 Water for the processing of medical devices (002).pdf

ANSI/AAMI

ST108:2023

Water for the processing of medical devices

American National Standard

Advancing Safety in Health Technology

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American National Standard ANSI/AAMI ST108:2023

Water for the processing of medical devices

Approved 30 June 2023 by

AAMI

Approved 4 August 2023 by American National Standards Institute, Inc.

Abstract: This standard covers the selection and maintenance of effective water quality suitable for processing medical devices. It provides guidelines for selecting the water quality necessary for the processing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.

Keywords: carbon filters, deionization, disinfection, distillation, medical devices, pasteurization, processing, reverse osmosis, rinsing, sediment filters, steam purity, sterilization, ultrafiltration, water filtration, water quality, washing, water softening, water quality, water treatment

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AAMI Standard

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AAMI

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© 2023 by the Association for the Advancement of Medical Instrumentation

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ISBN 978-1-57020-873-7

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Contents Page

Committee representation .............................................................................................................................................. v Foreword ........................................................................................................................................................................ x Introduction ................................................................................................................................................................... xi 1 Scope 2 Normative references 3 Terms and definitions 4 Roles and responsibilities 5 Risk analysis 6 Categories of water quality for medical device processing 7 Water quality selection and requirements 8 Water treatment systems installation and operation qualification 9 Water treatment systems performance qualification - evaluation of water quality 10 Water treatment systems routine monitoring 11 Continuous quality improvement 12 Water treatment systems maintenance 13 Special considerations Annex A (informative) Guidance on the application of the normative requirements Annex B (informative) Risk analysis Annex C (informative) Automated Endoscope Reprocessor (AER) Annex D (informative) Water used in cleaning and moist heat processes Annex E (informative) Water treatment technologies Annex F (informative) Water treatment system design Annex G (informative) Routine monitoring of water treatment equipment & produced water quality Annex H (informative) Maintaining microbiological quality Annex I (informative) Typical presentation of water quality issues during the processing of medical devices Bibliography

Figures

Figure 1—Stages of medical device processing in which water quality is a consideration

Figure F.1—Example process flow diagram (PFD)

Tables

Table 1—Multidisciplinary team responsibilities

Table 2—Categories and performance qualification levels of water quality for medical device processing

Table 3—Water quality for processing of devices requiring high-level disinfection

Table 4—Water quality monitoring requirements

Table 5—Frequency for water quality monitoring at water generation system

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Table 6—Frequency for water quality monitoring at point-of-water-use

Table A.1—Water descriptions

Table A.2—Water quality for processing devices

Table B.1—Tables of risk factors and effects

Table B.2— Impact of water temperature on sterilizer vacuum water supply pump performance

Table B.3—Work-related risks to staff

Table C.1—Water quality for LCSPS

Table E.1—Summary of water treatment methods

Table G.1—Pretreatment equipment monitoring

Table G.2—Primary water treatment equipment monitoring

Table G.3—Storage and Distribution Equipment Monitoring

Table I.1—Examples of observed problems during medical device processing that can be caused by poor water quality

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© 2023 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST108:2023 v

Committee representation

Association for the Advancement of Medical Instrumentation

AAMI Water Quality for Medical Device Processing Working Group

This standard was developed by the AAMI Water Quality for Medical Device Processing Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the standard does not necessarily mean that all working group members voted for its approval.

At the time This standard was published, the AAMI Water Quality for Medical Device Processing Working Group had the following members:

Cochairs: Terra Kremer Erin A. Kyle

Members: Anas Aljabo, SteriLabs Canada Inc.

Lindsay Arencibia, Lindsay Arencibia (Individual Expert) Kristy L. Azzolin, American Dental Association (ADA) James Weldon Baker, NuStream Filtration Inc Timothy Blackwell, Timothy Blackwell Person Rachel Bradley, Rachel Bradley (Individual Expert) Lisa Shifflett Brown, UVA Health Deborah Lynnette Bunn, University of Maryland Medical System Jonathan Burdach, Nanosonics Limited Cathy Castro, Vested Medical LLC Michael Scott Castro, Pall Medical - Port Washington Roxanne Charles, Roxanne Charles (Individual Expert) Nancy Chobin, Nancy Chobin (Individual Expert) Horlando Cintron, Memorial Sloan Kettering Cancer Center - Monmouth Jeremy Criss, Jeremy Criss (Individual Expert) Jacqueline A. Daley, Providence St Joseph Health System Frank Daniels, Virginia Commonwealth University Health System Nicholas Day, University Hospitals of Cleveland Loraine Durigan, Loraine Durigan (Individual Expert) Afif Jhoel Escheik, Crothall Healthcare Ernesto Rivera Esparza, Edwards Lifesciences Michael Flanagan, Zimmer Biomet Brian Flannigan, Phigenics LLC Sarah Frank, Element Materials Technology (fka ALG) Marcia Frieze, Case Medical Inc Naomi Gamm, Abbott Laboratories Joe Haney, AmeriWater Douglas F. Harbrecht, Sterility Assurance LLC Jeffrey N. Holland, Evoqua Water Technologies LLC Timothy Hurtado, Memorial Hermann Healthcare System David M. Jagrosse, David Jagrosse Consulting LLC Karissa Joosten, NAMSA Richard J. Kaestner Jr., Absolute Water Technologies Nancy E. Kaiser, STERIS Corporation | Healthcare Nicholas Kalanta, McLane Children's Hospital Sajedul Islam Khan, Apollo Hospital Dhaka Michal Koenner, Medtronic Inc Campus Margaret Konja, SpecialtyCare Terra Kremer, Johnson & Johnson

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Kaumudi Kulkarni, Healthmark Industries Company Inc Erin A. Kyle, Association of Perioperative Registered Nurses (AORN) Wesley Lantz, Zimmer Biomet William Leiva, 3M Health Care Angela M. Lewellyn, Advantage Support Services Inc Paul Littley, Integra LifeSciences Corporation Anne Mattern, Anne Mattern Person Michael Matthews, Association of Medical Device Service Organizations (AMDSO) John L. Mazzilli, Saddleback Memorial Medical Center Tom McElroy, IUVO BioScience Emily Mitzel, GE Healthcare Melissa G. Morgan, Moses H Cone Hospital - Cone Health Derek Mortisen, Intuitive Surgical Inc Mike Nolan, HIGHPOWER Validation Testing & Lab Services Inc Susumu Nozawa, Siemens Healthineers Kia Parker, The Ohio State Wexner Medical Center-University Hospital Alpa Patel, Sotera Health LLC Rebecca Peplau, Rebecca Peplau (Individual Expert) Janet M. Prust, St. Croix Standards Consulting, LLC Juan Migiel Ramos, Juan Migiel Ramos (Individual Expert) Marc B. Rogers, Advanced Sterilization Products (ASP) Don Rotter, Ecolab Mandy Ryan, Stryker Damien S. Berg, HSPA (fka IAHCSMM) Chuck Schaefer, Charles Schaefer (Individual Expert) Candace A. Schlicklin, Phoenix Children's Hospital Michael J. Schoene, Bausch & Lomb Inc Matthias Schöttler, Olympus America Inc Richard William Schule, Cleveland Clinic Linda Sue Schultz, Northside Hospital Surgical Services Atlanta Cynthia Seward, Kaiser Foundation Health Plan/Hospitals Donald Socha Esq., Getinge USA Len Sparks, VERDA Water Quality Systems Joan M. Spear, Joan M. Spear (Independent Expert) Nadine Swenson, Boston Scientific Corporation Janelle Trboyevich, Boston Scientific Corporation Steven E. Turtil, FDA/CDRH Melissa Walters, Melissa Walters (Individual Expert) Dean Wellman, Midmark Corporation Jonathan A. Wilder, Quality Processing Resource Group LLC Ariel Wimbush, Emory Healthcare David C. Winkler Jr., Veterans Administration (VA) Central Office Robin Woodland, Robin Woodland (Individual Expert) Jarl Yeager, Powder River Medical Resources Stephanie L. Young, Stephanie Young (Individual Expert) Roberto Zumbado, Philips

Alternates: Jennifer Barnickel, Vested Medical LLC Ralph J. Basile, Healthmark Industries Company Inc Jhmeid B. Billingslea, Advantage Support Services Inc Michael Bolcas, Integra LifeSciences Corporation Marco Bommarito, 3M Health Care Philip Ted Cantin, VERDA Water Quality Systems Greg Crego, Bausch & Lomb Inc Jeffery Daniels, Olympus America Inc

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Shawn Engberg, MD Furniture & Supply Lorraine Floyd, Johnson & Johnson Alex Freeman, Intuitive Surgical Inc Tara Jacobson, Abbott Laboratories Herbert J. Kaiser, STERIS Corporation | Healthcare Susan G. Klacik, HSPA (fka IAHCSMM) Angela Le, ResMed Inc.

Daniel Lightfoot PhD, Nanosonics Limited Shaun McGinley, Zimmer Biomet Kim Miller, HIGHPOWER Validation Testing & Lab Services Inc Ronald Moody, Veterans Administration (VA) Central Office Shane Pinkston, Getinge USA Michael Polozani, Case Medical Inc Shawn Powers, IUVO BioScience Kaleb Price, Northside Hospital Surgical Services Atlanta Nicola Revellin, GE Healthcare Jessica Rue, Boston Scientific Corporation Anne Schuler, LexaMed Ltd Richard Sparano, Medtronic Inc Campus Aaron Troutt, Williamson Medical Center Dustin E. Van Bree, Sotera Health LLC Jill A. Warren, Siemens Healthineers Mary Wen, FDA/CDRH Erika Wilson, Phigenics LLC

NOTE Participation by federal agency representatives in the development of this standard 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:

Cochairs: Janet M. Prust Patrick B. Weixel

Members: Gregory Darnall Aldrich, Fairbanks Memorial Hospital Anas Aljabo, SteriLabs Canada Inc.

Eseosa Tony Amenaghawon, Eseosa Tony Amenaghawon (Individual Expert) Brett Anderson, Cochlear Ltd Jennifer R. Asleson, Quality, Microbiology & Sterilization Services LLC Richard Bancroft, STERIS Corporation | Healthcare Marie K. Brewer, UnityPoint Health - Surgery Center Cedar Rapids Trabue Daley Bryans, BryKor LLC Jonathan Burdach, Nanosonics Limited Charles Cogdill, Medtronic Inc Campus Emily Craven, Boston Scientific Corporation Jacqueline A. Daley, Providence St Joseph Health System Gordon M. Ely, LexaMed Ltd Afif Jhoel Escheik, Crothall Healthcare Deannard Esnard, Deannard Esnard (Individual Expert) Nicole Felderman, CIVCO Medical Solutions Brian J. Fortier, Aorta Medical Inc Daniel Fowler, WuXi AppTec Inc Magnus Graham, BSI Healthcare Shelley Hagan, Henry Ford Health

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Ashley Hammer, Washington Regional Medical Center Joyce M. Hansen, Johnson & Johnson Douglas F. Harbrecht, Sterility Assurance LLC Deborah A. Havlik, DA Havlik Consulting Crystal Heishman, U of L Hospital - University of Louisville Ebow Holdbrook-Smith, WellSpan Health Mollie J. Holter, MicroBio Consulting LLC Stephanie Jean Homuth, Hennepin County Medical Center Warehouse Clark W. Houghtling, Cosmed Group Inc Angela G. Jensen, Rush Foundation Hospital Nicholas Kalanta, McLane Children's Hospital Susan G. Klacik, HSPA (fka IAHCSMM) Erin A. Kyle, Association of Perioperative Registered Nurses (AORN) Byron J. Lambert, Abbott Laboratories Marissa Jones Lewis, Veterans Administration (VA) Central Office Michael K. Loadman, Michael Loadman (Individual Expert) Emily Lorcheim, ClorDiSys Solutions, Inc Kelly Marcum, HCA Healthcare John L. Mazzilli, Saddleback Memorial Medical Center Patrick J. McCormick, Bausch & Lomb Inc Russell Mills, Zimmer Biomet Leslie Nichols, Mayo Clinic Gerry A. O'Dell, Gerry O'Dell Consulting James O'Reilly, St Joseph Health System - Trinity Health Ken Paddock, Baxter Healthcare Corporation Alberto Guzman Paret, Cordis US Corp Kia Parker, The Ohio State Wexner Medical Center-University Hospital Kimberly Patton, Performance Review Institute MedAccred Nancy Pickens, Nancy Pickens (Individual Expert) Karana M Pierre, Karana M Pierre (Individual Expert) Janet M. Prust, St. Croix Standards Consulting, LLC Joan E. Rickard, Montefiore Medical Center Angela Salmen, Angela Salmen (Individual Expert) Linda Sue Schultz, Northside Hospital Surgical Services Atlanta Joan M. Spear, Joan M. Spear (Independent Expert) Sopheak Srun, Quality Tech Services LLC Mark Swanson, Quality and Regulatory Expert Partners (QRX) Larry Talapa, 3M Health Care Julie TerWee, Pfizer Parenteral Center of Excellence James Treharn, St Peter's Health Sara Vinson, University of Florida Adrienne C. Watson, Adrienne Watson (Individual Expert) Sean Weir, Sean Weir (Individual Expert) Patrick B. Weixel, FDA/CDRH James Sidney Wiggs, Legacy Health System Ariel Wimbush, Emory Healthcare Martell Winters, Sotera Health LLC Roberto Zumbado, Philips

Alternates: Jennifer Benolken, DuPont Tyvek Medical and Pharmaceutical Protection Damien S. Berg, HSPA (fka IAHCSMM) Stacy Bohl, Boston Scientific Corporation Carolyn Braithwaite-Nelson, Philips Richard Burgess, BSI Healthcare Densley Coke, Densley Coke (Individual Expert) Kimbrell Darnell, Becton Dickinson & Company

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Aaron David DeMent, Sotera Health LLC April Doering, 3M Health Care Anna M. Grayson, Grayson Associates David Kelman, Sterile Edge Cathy Leckwart, WuXi AppTec Inc Paul Lorcheim, ClorDiSys Solutions, Inc Michelle Luebke, Baxter Healthcare Corporation Gerald E. McDonnell, Johnson & Johnson Shaun McGinley, Zimmer Biomet David Ford McGoldrick, Abbott Laboratories Shane Pinkston, Getinge USA Christine L. Render, Cosmed Group Inc Jimmy Reyes, Alcon Laboratories Inc Petra Richards, Kaiser Foundation Health Plan/Hospitals Susan Rogers, Veterans Administration (VA) Central Office Molly S. Swanson, Quality Tech Services LLC Lisa Ward, STERIS Corporation | Healthcare

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

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Foreword

This standard was developed by the AAMI Water Quality for Medical Device Processing Working Group under the auspices of the AAMI Sterilization Standards Committee. The objective of this standard is to set the quality requirements for the different categories of water used in processing of medical devices and provides guidance as to when and where to use water of each category. In addition, this standard provides information on how to verify that the water continues to meet those minimum requirements. This standard also provides valuable information for the performance qualification of a water treatment/delivery system and a monitoring program to ensure water quality remains within the stated specifications.

This is the first edition of this American National Standard, which revises and replaces AAMI TIR34 [1]. The goal of this standard is to specify the minimum requirements for the water quality and steam purity necessary to effectively process medical devices intended for use on a patient.

The professionals responsible for the processing of medical devices prior to use are experiencing increasing challenges including: the increasing complexity of modern medical devices with hidden, difficult to access areas (e.g., lumens and complex mechanisms) where clinical soil can become lodged; and the emerging and reemerging incidence of “superbugs” that must be removed or inactivated for patient safety but are able to survive processing in situations where soil removal is incomplete. Any limitation on or diminishment of cleaning efficacy can lead to patient morbidity or mortality and decreased device use life. Water of the appropriate quality for the processing of medical devices prior to clinical use is an important part of the solution to these problems.

A common factor in the processing of medical devices is the use of water. While medical devices cleared by the U.S.

Food and Drug Administration’s (FDA) for sale into the health care market have been provided with validated processing instructions and procedures, these procedures may not be completely effective if water of specified quality is not used.

Similarly, cleaning agents work better, and devices are rinsed more thoroughly if the water is of the specified quality.

Each health care facility may require a specific approach to treating water for processing needs based on a variety of factors.

The following verbal forms are used within AAMI documents to distinguish requirements from other types of provisions in the document:

“shall” and “shall not” are used to express requirements;

“should” and “should not” are used to express recommendations;

“may” and “may not” are used to express permission;

“can” and “cannot” are used as statements of possibility or capability;

“might” and “might not” are used to express possibility;

“must” is used for external constraints or obligations defined outside the document; “must” is not an alternative for “shall.”

Suggestions for improving this technical information report are invited. Comments and suggested revisions should be sent to Standards, AAMI, 901 N. Glebe Road, Suite 300, Arlington, VA 22203 or standards@aami.org.

NOTE This foreword does not contain provisions of the ANSI/AAMI ST108, Water for the processing of medical devices (ANSI/AAMI ST108:2023), but it does provide important information about the development and intended use of the document.

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Introduction

Water quality is an important consideration in all stages of medical device processing, as is the purity or chemical content of the steam that is generated for moist heat sterilization. The health care facility should have a multidisciplinary team in place that develops a strategy to confirm all aspects of water quality that impact the processing of medical devices within this standard. Appropriate water quality and steam purity in device processing requires collaboration between the personnel who process medical devices and the personnel who establish and maintain the water treatment system.

Water treatment and delivery systems can be configured in many ways to achieve the required water quality specifications. Water can be treated by a variety of methods that yield different levels of water quality. Gram-negative bacteria and nontuberculous mycobacteria can grow in water regardless of treatment process. The rate of growth and the microbial levels attained are a function of several factors related to the water (e.g., variety and concentration of organic contaminants, pH, temperature). Water systems that are closely monitored for quality reduce variability of processing conditions and effectiveness of cleaning and disinfection processes as well as reduce the potential of microbial proliferation. The importance of monitoring water quality to prevent problems with microbial proliferation cannot be overemphasized.

This standard defines multiple levels of water quality and steam purity suitable for medical device processing, and it describes the water treatment processes that can be utilized in order to produce water of the quality to meet each of these categories.

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© 2023 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST108:2023 1

American National Standard ANSI/AAMI ST108:2023

Water for the processing of medical devices 1 Scope

1.1 General

This standard establishes minimum requirements for the water quality used at different stages in the processing of medical devices (e.g., reusable devices and single-use devices provided non-sterile requiring processing prior to use such as non-sterile implants and processed single-use devices) to make them ready for use on the next patient. These requirements are established to assist medical device processing professionals in the selection of the appropriate water quality needed for cleaning, rinsing, disinfection, and sterilization of medical devices.

1.2 Inclusions

This standard covers the quality of the water delivered to the point-of-use and used in medical device processing (cleaning, rinsing, disinfection and sterilization). It defines water types based on the qualities possessed and where it will be used. Included in this document are:

a) Responsibility for the water management program;

b) Importance of water quality;

c) Adverse effects of water impurities on medical device processing;

d) Categories and requirements of water quality for medical device processing;

e) Selection of water of the appropriate quality;

f) Purity requirements of water used to generate steam;

g) Effective water treatment and qualification;

h) Considerations for ongoing maintenance, monitoring and quality improvement of the water treatment system;

i) Troubleshooting water quality issues.

This standard also provides definitions of terms and a bibliography.

1.3 Exclusions

This standard does not cover:

a) Water requirements for hemodialysis applications;

b) Water requirements for laboratory use;

c) Steam quality requirements (i.e., physical qualities of steam such as: moisture content, noncondensable gas content and Superheat). See ANSI/AAMI ST79 [8];

d) Water treatment performed within the medical device processing equipment (e.g., washers, washer/disinfectors, or automated endoscope reprocessors (AERs);

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e) Water quality of municipal water supply; and

f) Testing of water post use.

2 Normative references

There are no normative references used in the development of this document.

3 Terms and definitions

For the purpose of this standard, the following terms and definitions apply.

3.1 A0 measure of microbiological lethality delivered by a moist heat disinfection process expressed in terms of the equivalent time in seconds at 80 °C with reference to a microorganism with a z value of 10 K

[SOURCE: ISO 11139:2018]

3.2 absolute rated filter absolute filter rating meaning 99.9 % of the particles larger than a specified micron rating will be trapped on or within the filter

3.3 action level value from monitoring that necessitates immediate intervention

[SOURCE: ISO 11139:2018]

3.4 alert level value from monitoring providing early warning of deviation from specified conditions

[SOURCE: ISO 11139:2018]

3.5 anion negatively charged atom or molecule

3.7 automated endoscope reprocessor (AER) machine intended to disinfect or sterilize loads containing endoscopes

Note to entry: Some AERs have provisions for processing accessories.

3.8 bacterial endotoxin test

BET

assay for measuring bacterial endotoxin by combining a liquid test sample extract with Tachypleus or Limulus amebocyte lysate (TAL/LAL) reagent and measuring the resulting proportional reaction via visual, turbidimetric, or chromogenic techniques [7]

3.9 bioburden population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE: ISO 11139:2018]

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Note to entry: When measured, bioburden is expressed as the total count of bacterial and fungal colony-forming units (CFUs) per unit of measure.

3.10 biofilm a community of microorganisms; biofilms can consist of single or multiple types of microorganisms, either as actively multiplying, dormant, or generally associated with the biofilm structure; they can include “wet” (associated with water) or “dry” biofilms and are typically developed on or associated with surfaces or interfaces (e.g., water lines or storage systems); they are microbially derived communities characterized by cells that are irreversibly associated with a substratum, interface, or each other; they are often embedded in a matrix of extracellular polymeric substances (EPSs) that they produce; and exhibit mixed phenotypes with respect to growth rate, gene transcription, and resistance mechanisms)

Note to entry 1: The biofilm may consist of single or multiple bacterial species, fungal species, or both.

Note to entry 2: Some microscopic organisms have the ability, when growing in water or water solutions or in vivo (e.g., the bloodstream), to adhere to a surface and then exude over themselves a polysaccharide matrix. The matrix contains cells, living and dead, as well as polysaccharide (sometimes referred to as extracellular polymeric substance (EPS)) and prevents antimicrobial agents, such as sterilants, disinfectants, and antibiotics, from reaching the microbial cells.

3.11 cation positively charged atom or molecule

3.12 chemical sterilization validated process that uses a chemical agent and is designed to render a product free of viable microorganisms

3.13 chloramines compounds formed by the reaction of aqueous chlorine with ammonia or an amine compound

3.14 chlorides an ionic compound of chlorine with a metallic element or group, especially a salt of the anion Cl−; for example, sodium chloride NaCl or calcium chloride CaCl2

3.15 chlorine, free concentration of residual chlorine in water that is present as dissolved gas (Cl2), hypochlorous acid (HClO), and/or hypochlorite ion (ClO)

Note to entry: The three forms of free chlorine exist together in equilibrium; their relative proportions are determined by the pH and temperature of the water.

3.16 clean (pure) steam steam generated using “a pure steam generator (PSG)" when fed with water for injection (WFI). It is pyrogen-free, dry, saturated steam that shall meet the requirements of WFI when condensed

Note to entry: Clean steam is defined by PDA in Technical Reports 1:2007 and 48:2010 and in USP 31.

3.17 cleaning removal of contaminants to the extent necessary for further processing or for the intended use

[SOURCE: ISO 11139:2018]

Note to entry: In health care facilities, cleaning consists of the removal, usually with cleaning agent (e.g., a physical or chemical entity, or combination of entities, having activity to render an item clean) and water, of adherent soil (e.g., blood, protein substances, A A

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4 © 2023 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST108:2023 and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical (automated) process that prepares the items for safe handling or further decontamination.

3.18 cleaning agent physical or chemical entity, or combination of entities, having activity to render an item clean

[SOURCE: ISO 11139:2018]

3.19 conductivity the indirect measurement of ion concentration in water; conductivity measures the ion facilitated electron flow in water

Note to entry: Conductivity is measured by a conductivity meter and has units of microsiemens/cm (µS/cm). A microsiemen is defined as conductance such that the current through the device will increase by one milliamp (mA) for every increase of one volt potential difference across the device.

3.20 critical devices as defined by Spaulding’s classification, medical devices that are introduced into or have contact with the bloodstream or normally sterile areas of the body; examples include, but are not limited to, implants and surgical instruments

3.21 critical water water meeting the quality requirements in Table 2.

Note to entry: This document provides requirements and recommendations for the appropriate use of water of this quality.

3.22 cross-flow filtration process in which particulates (e.g., microbiological species, insoluble particulates) are removed from liquids or gases by passage through a porous material, with the filtered particles flowing in one direction and the filtrate flowing in the opposite direction

3.23 D value time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated dose conditions

3.24 dead-leg with respect to water distribution systems, piping that is more than 3-5 times as long as its internal diameter and that does not have constant water flow

3.25 decontamination removal of contaminants to a specified level.

Note to entry: A decontamination process can include a cleaning (physical removal) and/or an antimicrobial (e.g., disinfection) process, depending on the defined level previously specified as being appropriate for a defined purpose, and is often a combination of these processes [BI&T 2021]

3.26 deionization

DI

water treatment process that uses ion-exchange resins to produce high purity water

3.27 depth filter filter that consists of mats of fibers and generally has a broad pore-size distribution and high particle-holding capacity

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Note to entry: Depth filters are often used as prefilters to remove large particles and to extend the service life of subsequent filters.

3.28 disinfection process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose

[SOURCE: ISO 11139:2018]

3.29 distillation water treatment process that uses vaporization and subsequent condensation to purify water

Note to entry: For purposes of this standard, distilled water is considered to be water generated from a properly maintained still on-site, not bottled water labeled as distilled.

3.30 endotoxin lipopolysaccharide component of the cell wall of Gram-negative bacteria that is heat stable and elicits a variety of inflammatory responses in animals and humans

[SOURCE: ISO 11139:2018]

3.31 endotoxin unit

EU

standard unit of measure for endotoxin activity initially established relative to the activity contained in 0.2 nanograms of the U.S. Reference Standard Endotoxin Lot EC-2 [29], [7]

Note 1 to entry: FDA’s reference endotoxin EC-6, USP Lot G [29], and the World Health Organization’s primary international endotoxin standard (IS) are sublots of the same endotoxin preparation, making the EU and IU (International Unit) equal [76].

Note 2 to entry: unit of measure for endotoxin is EU/mL

3.32

EPA

U.S. Environmental Protection Agency

3.33

FDA

U.S. Food and Drug Administration

3.34 feedwater water being fed to water treatment equipment or steam generator (e.g., potable water delivered to deionizer)

3.35 green sand manganese-containing ion exchange resin used to remove soluble iron and manganese from water

Note to entry: The manganic ion form in the ion exchange resin oxidizes ferrous and manganous ions in water to their insoluble ferric and manganic forms. The resulting manganous ion in the ion exchange resin can be regenerated to the manganic ion form with potassium permanganate.

3.36 hardness, water concentration of calcium and magnesium ions in water, expressed as parts per million (ppm) or milligrams per liter (mg/L) of calcium carbonate (CaCO3) equivalents

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Note to entry: Soft water is 0 to 60 ppm CaCO3, moderately hard water is 60 to 120 ppm, hard water is 120 to 180 ppm, and very hard water is greater than 180 ppm.

3.37 heterotrophic plate count

HPC

procedure that estimates the number of viable bacteria that use organic molecules as their principal energy source. It can be used to determine the efficiency of a water treatment process and the quality of the water produced

Note to entry: Three different methods, using three different types of media, can be used to perform a heterotrophic plate count:

spread plate, pour plate, and membrane filtration.

3.38 high-level disinfectant

HLD

agent capable of killing bacterial spores when used in sufficient concentration under suitable conditions

Note to entry: According to the FDA, an HLD is a liquid chemical sterilant (LCS) used for a shorter exposure time than that required to pass the AOAC sporicidal activity test as a sterilant.

3.39 high-level disinfection complete elimination of all microorganisms in or on an instrument, except for large numbers of bacterial spores [43]

Note to entry: For a process that can be used for both chemical sterilization and high-level disinfection, the contact time for high-level disinfection is shorter than that necessary for sterilization, under otherwise identical conditions.

3.40 hydrophobic does not readily absorb water; insoluble in water

3.41 inorganic solutes compounds (e.g., salts) that do not contain organic carbon and that are dissolved in a liquid

3.42 installation qualification

IQ

process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification

[SOURCE: ISO 11139:2018]

3.43 intermediate-level disinfectant agent that destroys all vegetative bacteria, including tubercle bacilli, lipid and some nonlipid viruses, and fungi, but not bacterial spores [42]

3.44 Limulus amebocyte lysate

LAL

reagent extracted from amebocytes taken from hemolymph of the horseshoe crab, Limulus polyphemus, which reacts with endotoxin, to form a gelatinous clot and is used to estimate endotoxin levels in bacterial endotoxin test methods [7]

3.45 lipopolysaccharide

LPS

gram-negative bacterial cell wall component typically composed of lipid A, a core polysaccharide, and an O-side chain;

see also endotoxin [7]

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3.46 liquid chemical sterilant

LCS

solution of a chemical that has been validated to provide microbial kill adequate to obtain FDA clearance for a sterilization label claim; see definition 3.67

3.47 low-level disinfection process that kills most vegetative bacteria, some viruses, and some fungi, but not mycobacteria or bacterial spores

3.48 microfilter filter designed to remove particles in the range of 0.1 to 3 microns (µm) in diameter

3.49 microorganism entity of microscopic size, encompassing bacteria, fungi, protozoa, and viruses

[SOURCE: ISO 11139:2018]

3.50 non-critical devices as defined by Spaulding’s classification, medical devices that contact only intact patient skin; examples include, bedpans, reusable anesthesia masks, and blood pressure cuffs

3.51 non-pyrogenic does not induce a fever; term used to describe an item or product that contains endotoxin levels less than or equal to specified limits [7]

Note to entry: Nonpyrogenic can also be used to describe and label health care products that contain endotoxin levels less than specified limits and do not elict a pyrogenic reaction. Other products (e.g., pyrgogen-free water) can have alternate labeling requirements.

3.52 non-pyrogenic water water containing endotoxin at less than a specified endotoxin limit demonstrated to produce a pyrogenic response

3.53 operational qualification

OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE: ISO 11139:2018]

3.54 pasteurization disinfection process that uses hot water at temperatures of 65 °C to 77 °C (150 °F to 170 °F) for a contact time of at least 30 minutes

3.55 performance qualification

PQ

process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements

[SOURCE: ISO 11139:2018]

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3.56 pH level number denoting alkalinity or acidity

Note to entry: The pH scale is logarithmic and runs from 0 to 14; the neutral point is 7. Numbers below 7.0 indicate acidity, and those above 7.0 indicate alkalinity.

3.57 plant or house steam steam produced in health care settings using water from the municipal supply that can either be treated or untreated to meet the specifications for feedwater for the boiler

3.58 point-of-use treatment (of clinically used medical devices) point-of-use treatment refers collectively to the activities that the user of a medical device performs at the point of use (e.g., where the procedure was performed) to prepare it for processing; point-of-use treatment occurs immediately after patient use and can include rinsing, flushing, wiping (to prevent biofilm formation and drying of soil), disconnecting accessories, preparing handoff communication, and preparing the instrument/device for transport to the decontamination facility and placing it in an appropriately labeled container

3.59 point-of-water use

POU

closest point in the distribution loop where the water is exposed to a medical device during processing

3.60 point-of-water use system POU system water treatment system in which purification (usually filtration) takes place just before a single water supply outlet

Note to entry: Examples of a POU system are a filter in the line leading to the faucet (such as a filter under a kitchen sink) and a filter attached to the faucet (such as a screw-on tap filter).

3.61 potable water water that has been treated and delivered in a manner so that it meets EPA guidelines intended for direct or indirect human consumption [21]

3.62 process to prepare a device, instrument, or piece of equipment for reuse by any or a combination of the following processes;

point-of-use treatment, cleaning, disinfection, sterilization, and rinsing at appropriate stages

3.63 process steam steam produced in a health care facility for sterilization using a stainless steel boiler fed with Critical Water

3.64 product water water that has been treated to achieve a predetermined quality at the output of the treatment system or process

3.65 pure steam generator a pure (or clean) steam generator converts incoming water for injection (WFI) feedwater into clean steam using plant steam as the heating medium. The plant steam does not contact the clean steam. The steam generator is constructed so as to not add any impurities to the steam produced

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3.66 pyrogen any substance that induces a fever

[SOURCE: AAMI ST72:2019]

Note to entry: Pyrogens can be classified into two groups: microbial (e.g., bacteria, fungi, viruses) and nonmicrobial (e.g., drugs, device materials, steroids, plasma fractions).

3.67 pyrogenic induces a fever; term used to describe an item or product that contains endotoxin levels above specified limits

[SOURCE: AAMI ST72:2019]

3.68 residue remains after a process, preparation, separation, or purification

3.69 resistivity ability of water to resist the flow of electricity; a measure of the resistance of water and the inverse of conductivity

Note to entry: Resistivity is measured by a resistance monitor and described in megaohms-cm (MΏ-cm).

3.70 reverse osmosis

RO

membrane separation process for purifying water that is based on molecular sieving and ionic rejection and that is effective in removing ions as well as dissolved organic contaminants with molecular weights above 100 daltons

3.71 rinsing process of flushing the exterior or interior of a medical device with a liquid such as water to remove organic and inorganic material at various stages in medical device processing

3.72 sediment material that settles at the bottom of a liquid

3.73 semi-critical devices as defined by Spaulding’s classification, medical devices that contact intact mucous membranes or non-intact skin but do not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body; examples include, but are not limited to, gastrointestinal endoscopes and respiratory therapy equipment

3.74 single-use medical device medical device labelled or intended to be used on one individual during a single procedure

Note to entry: A single-use medical device is not intended to be further processed and used again.

[SOURCE: ISO 11139:2018]

3.75 softening technique that removes water hardness (multivalent positive ions e.g., calcium, magnesium, and iron)

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3.76 steam vaporized water that is used in specific applications for medical device processing and is produced by a centralized boiler, generator, or heat exchanger at point-of-use; when tested as a condensate meets specified criteria

3.77 steam purity the chemical characteristics of steam relative to the contaminants in the steam condensate shown in Table 2

3.78 sterilant or sterilizing agent physical or chemical entity, or combination of entities, that has sufficient microbicidal activity to achieve sterility under defined conditions

3.79 sterile free from viable microorganisms

3.80 sterile processing department/area an area that processes and controls medical supplies, devices, and equipment, sterile and non-sterile, for some or all patient care areas of the facility

[SOURCE: ISO 11139:2018]

Note to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven. See sterilization.

3.81 sterilization validated process used to render a product free from viable microorganisms

[SOURCE: ISO 11139:2018]

Note to entry: In a sterilization process, the nature of microbiological inactivation is exponential and, thus, the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero.

3.82 sterilization process series of actions or operations needed to achieve the specified requirements for sterility

Note to entry: This series of actions includes pretreatment of product (if necessary), exposure under defined conditions to the sterilizing agent, and any necessary post-treatment. The sterilizing process does not include any cleaning, disinfection, or packaging operations that precede sterilization.

3.83 storage tank tank in which water is stored for future use, typically at the user’s facility

3.84 submicron filter mechanical filtration process that has the capacity to retain particles or organisms that are less than 1 micron (µm) in their smallest cross-sectional dimension

3.85 tap water water that is obtained from the tap, faucet, or fixture

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Note to entry: Tap water refers to the location from which the water is obtained. This water may not meet the requirements for Utility Water.

3.86 thermal disinfection disinfection process that uses hot water at adequate temperatures (higher than 60 °C) to kill residual microorganisms

Note to entry: The efficacy of microbial kill depends on the temperature and exposure time. For a more detailed discussion, see Annex E.

3.87 total dissolved solids

TDS

a measure of the dissolved combined content of all inorganic and organic substances present in a liquid in molecular, ionized, or micro-granular (colloidal sol) suspended form

Note to entry: TDS concentrations are often reported in parts per million (ppm)

Note to entry: TDS measurements are commonly used to assess the performance of water treatment systems. TDS values are often expressed in terms of CaCO3 or NaCl equivalents (ppm).

3.88 total organic carbon

TOC

measure of both natural (residuals from natural plant and animal decomposition) and synthetic organic substances

3.89 ultrafilter membrane filter with a pore size in the range 0.001 to 0.05 μm

Note to entry: The performance of an ultrafilter is usually rated in terms of a nominal molecular weight cut-off (MWCO), which is defined as the smallest molecular weight species for which the filter membrane has more than 90 % rejection. Ultrafilters with a nominal MWCO of 20,000 or less are generally adequate for endotoxin removal. Ultrafilters are not commonly used to remove particulates.

3.90 utility water water meeting the quality requirements in Table 2

NOTE: This document provides requirements and recommendations for the appropriate use of water of this quality.

3.91 validation confirmation process, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

[SOURCE: ISO 11139:2018]

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

3.92 verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

[SOURCE: ISO 11139:2018]

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