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ISO 17665:2024(en)
ISO - Cover page
Foreword
Introduction
1 Scope
 1.1 Inclusions
 1.2 Exclusions
2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization
 5.1 Sterilizing agent
 5.2 Microbicidal effectiveness
 5.3 Effects on materials
 5.4 Environmental consideration
6 Process and equipment characterization
 6.1 General
 6.2 Process characterization
 6.3 Saturated steam sterilization processes
 6.4 Contained product sterilization processes
 6.5 Equipment
7 Product definition
8 Process definition
9 Validation
 9.1 General
 9.2 Installation qualification (IQ)
 9.3 Operational qualification (OQ)
 9.4 Performance qualification (PQ)
 9.5 Review and approval of validation
10 Routine monitoring and control
 10.1 Routine monitoring
 10.2 Operational status
 10.3 Process verification
 10.4 Evaluation of additional data for saturated steam sterilization processes
 10.5 Evaluation of additional data for contained product sterilization processes.
 10.6 Record retention
11 Product release from sterilization
12 Maintaining process effectiveness
 12.1 Purpose
 12.2 Demonstration of continued effectiveness
 12.3 Recalibration
 12.4 Equipment maintenance
 12.5 Requalification
 12.6 Assessment of change
Annex A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements
Annex B (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation
Annex C (informative) Establishment and evaluation of a sterilization process primarily based on the measurement of physical parameters
Annex D (informative) Examples of moist heat sterilization cycles
Annex E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization
Annex F (informative) Guidance on the application of the normative requirements in health care facilities
Annex G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat
Annex H (informative) Guidance on the application of the normative requirements in industrial settings
Bibliography
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International

Standard

ISO 17665
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Stérilisation des produits de santé — Chaleur humide — Exigences pour le développement, la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs médicaux
Reference number
ISO 17665:2024(en)
First edition
2024-03
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ContentsPage

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This first edition cancels and replaces ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013, which have been technically revised.
The main changes compared to the previous editions are as follows:
combined ISO 17665-1, ISO/TS 17665-2 and ISO/TS 17665-3 into a single standard.
A list of all parts in the ISO 17665 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions, can, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices generally can best be described by an exponential relationship between the number of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there is always a finite probability that a microorganism can survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one product in a population subjected to sterilization processing cannot be ensured and the expression of sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a product item.
The process variables for a moist heat sterilization process, i.e. those which contribute towards microbial lethality, are exposure to adequate temperature for a prerequisite time in the presence of moisture. Moist heat sterilization can be utilised as a saturated steam process, where saturated steam is allowed to directly contact all surfaces to be sterilized, or as a contained product sterilization process, where steam, steam mixed with air or other gas, or hot water under pressure are used as the heating medium in order to generate moist heat within the sealed contained product. The term saturated steam describes a theoretical state in which water and vapour are in equilibrium and that no other gases are present. In practice theoretical saturated steam state conditions are not achieved. Mixtures of steam and NCGs, albeit in very low levels, will be supplied to the sterilizer and employed as the sterilizing agent, moist heat.
This document describes requirements that, if met, will provide a moist heat sterilization process intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, conformance with the requirements, ensures this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after every sterilization process is complete. Specification of this probability is a matter for regulatory authorities and can vary from country to country (see, for example, EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognise that, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process is monitored routinely, and the equipment is maintained.
Exposure to a properly validated, accurately controlled, monitored and recorded sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use. Attention is therefore given to a number of factors including:
a)
the microbiological status of either incoming raw materials or components, or both;
b)
the validation and routine control of any cleaning and disinfection procedures used on the product;
c)
the control of the environment in which the product is manufactured, assembled and packaged;
d)
the control of equipment and processes;
e)
the control of personnel and their hygiene;
f)
the manner and materials in which the product is packaged;
g)
the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this has an impact upon the effectiveness of a sterilization process. It is preferable that products that have been used in a health care setting and that are being presented for sterilization in accordance with the instructions for use (see ISO 17664-1) be regarded as special cases. There is the potential for such products to possess a wide range of contaminating microorganisms (bioburden) and either residual inorganic or organic contamination, or both, in spite of the application of a cleaning process. Hence, particular attention is given to the validation and control of the cleaning and disinfection processes used during processing. The ISO 15883 series provides requirements for and information on automated cleaning and disinfection processes.
This document describes the requirements for ensuring that the activities associated with the process of moist heat sterilization are performed properly. The requirements are the normative parts of this document with which conformance is claimed. The guidance given in the informative Annexes is not intended as checklists for assessing conformance with the requirements of this document. The guidance in the informative Annexes is intended to assist in obtaining a uniform understanding and implementation of the requirements in this document by providing explanations, rationales, examples and methods that are regarded as being suitable means for conforming with the requirements. Methods other than those given in the guidance can be used if they are effective in achieving conformance with the requirements of this document.
The development, validation and routine control of a sterilization process comprise a number of discrete but interrelated activities, e.g. calibration, equipment maintenance, product definition, process definition, installation qualification (IQ), OQ and PQ, during which, along with other characteristics, compatibility of product and materials will be ascertained. While the activities required by this document have been grouped together and are presented in a particular order, this document does not require that the activities be performed in the order that they are presented. The activities required are not necessarily sequential, as the programme of development and validation can be iterative. It is possible that performing these different activities will involve a number of either separate individuals or organizations, or both, each of whom undertake one or more of these activities. This document does not specify the particular individuals or organizations who are responsible for carrying out the activities.
The requirements of this document are applicable to all settings where moist heat sterilization of medical devices is carried out. However, this document or part of it can be applied to the moist heat sterilization of other products.
Medical devices processed in an industrial setting can, in certain circumstances, be manufactured using standardised processes that result in product with a known and controlled bioburden prior to sterilization. Medical devices processed in health care facilities can include a wide variety of product with varying levels of bioburden. Appropriate and thorough cleaning and, where necessary for safe handling, decontamination processes, are used prior to presenting product for sterilization. Mixed product loads are common in facilities reprocessing medical devices with throughput volumes dictated by historical and predicted demand for sterile product.
Annex A provides guidance on the principles of moist heat sterilization and provides a rationale for the requirements. Specific guidance for health care facilities is given in Annex F and for industrial applications, in Annex H. The numbering and structure of the clauses in Annex F and Annex H correspond to the numbering and structure of the clauses in the normative requirements section of this document.
An overview of the purpose of each normative section is provided at the beginning of Clauses 5 to 12 (see ISO 14937). Table A.1 summarises the purpose of each normative section and suggests the roles and responsibilities for the organisations and personnel involved in each element of the development, validation and routine control of a moist heat sterilization process and moist heat sterilizer.
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International StandardISO 17665:2024(en)
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

1Scope

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

1.1Inclusions

Moist heat sterilization processes covered by this document include, but are not limited to:
a)
saturated steam sterilization in which air is removed by passive purging (gravity displacement principle);
b)
saturated steam sterilization in which air is removed by active air removal (dynamic air removal, pre-vacuum/fractionated vacuum principle);
c)
contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;
d)
contained product sterilization in which heat transfer is achieved by water sprays;
e)
contained product sterilization in which heat transfer is achieved by water immersion.
NOTE 1See Annex D where the processes are explained further.
NOTE 2Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products and industrial applications.

1.2Exclusions

1.2.1This document does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 1See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
NOTE 2Specific regulations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
1.2.2This document does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
1.2.3This document does not detail a specified requirement for designating a medical device as “sterile.”
NOTENational or regional requirements can designate medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.4This document does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.
NOTEThere can be applicable national or regional regulations for operational safety.

2Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11138-1:2017, Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-3:2017, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11140 (all parts), Sterilization of health care products — Chemical indicators
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 11737-2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

3Terms and definitions

For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
ISO Online browsing platform: available at https://www.iso.org/obp
IEC Electropedia: available at https://www.electropedia.org/
3.1
air detector
device designed to detect the presence of non-condensable gases in the chamber or in a stream of steam and condensate
[SOURCE: ISO 11139:2018, 3.9]
3.2
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to programmed cycle parameters
[SOURCE: ISO 11139:2018, 3.18]
3.3
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[SOURCE: ISO 11139:2018, 3.29]
3.5
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by the measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication
[SOURCE: ISO 11139:2018, 3.31]
3.6
chamber
part of equipment in which a load is processed
[SOURCE: ISO 11139:2018, 3.36]
3.7
chemical indicator
test system that reveals change in one or more pre-specified process variables based on a chemical or physical change resulting from exposure to a process
[SOURCE: ISO 11139:2018, 3.43]
3.8
conditioning
treatment of product prior to the exposure stage to attain a specified temperature, relative humidity, or other process variable throughout the load
[SOURCE: ISO 11139:2018, 3.58]
3.9
contained product
load for which the ambient media within a chamber do not come into direct contact with the item to be processed
Note 1 to entry: The environment within the sterilizer is used for heating and cooling purposes only, not for achieving the sterilization effect, e.g. a solution in a sealed bottle.
3.10
contained product sterilization
validated process where indirect contact of a heating medium on the external surfaces of contained product is used to create moist heat internally to achieve the specified requirements for sterility within the contained product
Note 1 to entry: The environment within the sterilizer is used for heating and cooling purposes only, not for achieving the sterilization effect, e.g. a solution in a sealed bottle.
[SOURCE: ISO 11139:2018/Amd1:2024, 3.332, modified — Note 1 to entry added.]
3.11
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action.
[SOURCE: ISO 11139:2018, 3.64]
3.12
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
[SOURCE: ISO 11139:2018, 3.65]
3.13
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication, and recording of an operating cycle
[SOURCE: ISO 11139:2018, 3.72]
3.14
cycle variable
property used to control, monitor, indicate, or record an operating cycle
[SOURCE: ISO 11139:2018, 3.74]
3.15
D value
D10 value
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test microorganisms
Note 1 to entry: For the purposes of this document, D value refers to the exposure period necessary to achieve 90 % reduction.
Note 2 to entry: The definition of D value assumes that a plot of log10 of population versus time of exposure is linear within accepted tolerances.
[SOURCE: ISO 11139:2018, 3.75, modified — Notes to entry have been added.]
3.16
development
act of elaborating a specification
[SOURCE: ISO 11139:2018, 3.79]
3.17
equilibration time
period between the attainment of defined sterilization process parameters at the reference measurement point and the attainment of the specified sterilization process parameters at all points within the load
Note 1 to entry: For the purposes of this document the process parameter to which this definition refers is temperature.
Note 2 to entry: Equilibration time is also known as sterilization time lag.
[SOURCE: ISO 11139:2018, 3.105, modified — Notes to entry have been added.]
3.18
equipment maintenance
combination of all technical and associated administrative actions intended to keep equipment at a state in which it can perform its required function, or restore it to such a state
[SOURCE: ISO 11139:2018, 3.106]
3.19
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO 11139:2018, 3.107]
3.20
evaluation
systematic and objective comparison of the measured results either with one another or with a specification to be met in initial, intermediate and final tests
Note 1 to entry: Evaluation analyses the level of achievement of both expected and unexpected results by examining the results chain, processes, contextual factors and causality using appropriate criteria. An evaluation provides credible, useful evidence-based information that enables the timely incorporation of its findings, recommendations and lessons into the decision-making processes of organizations and stakeholders.
[SOURCE: ISO 9022-1:2016, 2.10, modified — Added "systematic and objective" at the beginning of the definition and Note 1 to entry has been added.]
3.21
exposure stage
cycle stage between the introduction of the sterilizing or disinfecting agent into the chamber and when the agent is removed or neutralised
Note 1 to entry: For the purposes of this document the exposure stage only includes that part of the process for which microbial lethality is claimed.
[SOURCE: ISO 11139:2018 & Amd 1:2024, 3.111, modified — Note 1 to entry has been added]
3.22
Fo value
measure of microbiological lethality delivered by a moist heat sterilization process expressed in terms of the equivalent time, in minutes, at a temperature of 121,1 °C with reference to microorganisms with a z value of 10 °C
[SOURCE: ISO 11139:2018, 3.113.1, modified — 10 K was replaced by °C (by convention, z value is expressed in °C).]
3.23
FBIO value
expression of the resistance of a biological indicator calculated as the product of the logarithm to base 10 of the initial population of microorganisms and the D value
[SOURCE: ISO 11139:2018, 3.113.2, modified — "to base 10" added to the definition]
3.24
FBIOLOGICAL value
expression of the delivered lethality of a process, measured in terms of actual kill of microorganisms on or in a biological indicator challenge system
Note 1 to entry: FBIOLOGICAL can be calculated by multiplying the D121 value by the difference between the log to the base ten of the starting population and the log to the base ten of the enumerated population after processing.
3.25
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified tolerance(s)
[SOURCE: ISO 11139:2018, 3.116]
3.26
health care facility
HCF
dedicated setting where health care professionals deliver services for care of patients
EXAMPLE        Hospitals, free standing ambulatory surgical centres, nursing homes, extended care facilities, medical, dental and physician offices or clinics and other specialized treatment facilities.
[SOURCE: ISO 11139:2018 and Amd 1:2024, 3.339]
3.27
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including biopharmaceutical
[SOURCE: ISO 11139:2018, 3.132]
3.28
holding time
<moist heat sterilization> period for which the temperatures at the reference measurement point and all points within the load are continuously within the sterilization temperature band
[SOURCE: ISO 11139:2018 & Amd 1:2024, 3.133.1]
3.29
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, 3.220.2]
3.30
load
product, equipment or materials to be processed together within an operating cycle
[SOURCE: ISO 11139:2018, 3.155]
3.31
load configuration
distribution and orientation of a load
Note 1 to entry: For the purposes of this document the definition refers to the placement of a load in the chamber and includes fixed chamber parts and the numbers and types of product presented for sterilization.
[SOURCE: ISO 11139:2018, 3.156, modified — Note 1 to entry has been added.]
3.32
measuring chain
series of elements of a measuring instrument or measuring system, which constitutes the path of the measurement signal from the input (quantity subject to measurement) to the output (the result of the measurement)
[SOURCE: ISO 11139:2018, 3.165]
3.33
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
diagnosis, prevention, monitoring, treatment, or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
investigation, replacement, modification, or support of the anatomy, or of a physiological process;
supporting or sustaining life;
control of conception;
disinfection of medical devices;
providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others include:
items specifically intended for cleaning or sterilization of medical devices;
pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for sterilization;
disinfection substances;
aids for persons with disabilities;
devices incorporating animal and/or human tissues;
devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018 and Amd 1:2024, 3.166]
3.34
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
[SOURCE: ISO 11139:2018, 3.176]
3.35
moist heat
thermal energy in the presence of moisture used as the sterilizing agent to achieve the specified requirements for sterility
3.36
non-condensable gas
NCG
air and/or other gas which will not liquefy under the conditions of a saturated steam sterilization process
[SOURCE: ISO 11139:2018, 3.183, modified — Added “sterilization” and abbreviation NCG.]
3.37
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, 3.220.3]
3.38
operating cycle
complete set of stages of a process that is carried out, in a specified sequence
Note 1 to entry: Loading and unloading are not part of the operating cycle.
[SOURCE: ISO 11139:2018, 3.188]
3.39
overkill approach
method of defining a sterilization process that achieves a maximal sterility assurance level (SAL) for product substantially less than 10−6
[SOURCE: ISO 11139:2018, 3.190]
3.40
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.41
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, 3.220.4]
3.42
plateau period
equilibration time plus the holding time
[SOURCE: ISO 11139:2018, 3.195]
3.43
porous
<sterilizer load> permeable to water, air or other fluids
[SOURCE: ISO 11139:2018, 3.197]
3.44
preconditioning
treatment of product, prior to the operating cycle, to attain specified values for temperature, relative humidity, and/or other process variables
[SOURCE: ISO 11139:2018, 3.200]
3.45
preventive action
action to eliminate the cause of a potential nonconformity or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
[SOURCE: ISO 11139:2018, 3.203]
3.46
process challenge device
PCD
item providing a defined resistance to a cleaning, disinfection, or sterilization process and used to assess performance of the process
Note 1 to entry: For the purpose of this document, the item can be product, simulated product or other reference device. The item can contain a physical indicator, biological indicator or chemical indicator.
[SOURCE: ISO 11139:2018, 3.205, modified — Note 1 to entry has been added.]
3.47
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO 11139:2018, 3.211]
3.48
process variable
chemical or physical attribute within a cleaning, disinfection, packaging, or sterilization process, changes in which can alter its effectiveness
Note 1 to entry: For the purposes of this document, process variables are conditions within a sterilization process, changes in which alter microbicidal effectiveness, i.e. exposure time and temperature in the presence of moist heat.
[SOURCE: ISO 11139:2018, 3.213, modified — EXAMPLES have been deleted and Note 1 to entry has been added.]
3.49
product
tangible result of a process
EXAMPLE        Raw material(s), intermediates, sub-assembly(ies), healthcare product(s).
[SOURCE: ISO 11139:2018, 3.217]
3.50
product family
group or subgroup of product characterized by similar attributes determined to be equivalent for evaluation and processing purposes
Note 1 to entry: See Annex G.
[SOURCE: ISO 11139:2018, 3.218, modified — Note 1 to entry has been added.]
3.51
reference load
specified load created to represent combinations of items that provide defined challenge(s) to a process
[SOURCE: ISO 11139:2018, 3.226]
3.52
reference measurement point
location of the sensor controlling the operating cycle
[SOURCE: ISO 11139:2018, 3.227]
3.53
reference microorganism
microbial strain obtained from a recognized culture collection
[SOURCE: ISO 11139:2018, 3.228]
3.54
reproducibility
condition of measurement, out of a set of conditions that includes different locations, processors, measuring systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measuring systems may use different measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical.
3.55
requalification
repetition of part or all of validation for the purpose of confirming the continued acceptability of a specified process
[SOURCE: ISO 11139:2018, 3.220.5]
3.56
saturated steam
water vapour in a state of equilibrium between its liquid and gas phases
[SOURCE: ISO 11139:2018, 3.241]
3.57
saturated steam sterilization
validated process which involves the direct contact of saturated steam as the sterilizing agent on product surfaces to achieve the specified requirements for sterility
[SOURCE: ISO 11139:2018 and Amd 1:2024, 3.368]
3.58
services
supplies from an external source, needed for the function of equipment
EXAMPLE        Steam, electricity, water, compressed air, drainage.
[SOURCE: ISO 11139:2018, 3.252, modified — EXAMPLES have been added.]
3.59
specify
stipulate in detail within an approved document
[SOURCE: ISO 11139:2018, 3.259]
3.60
spore log reduction
SLR
negative exponent to the base 10 describing the decrease in the number of spores
[SOURCE: ISO 11139:2018, 3.260
Note 1 to entry: It is expressed as a logarithm.
3.61
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.62
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.63
sterility
state of being free from viable microorganisms
Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.
[SOURCE: ISO 11139:2018, 3.274]
3.64
sterility assurance level
SAL
probability of a single viable microorganism occurring on an item after sterilization
Note 1 to entry: It is expressed as the negative exponent to the base 10.
Note 2 to entry: The term SAL takes a quantitative value, generally 10-6 or 10-3. When applying this quantitative value to assurance of sterility, an SAL of, for example, 10-6 has a lower value but provides a greater assurance of sterility than an SAL of 10-3.
[SOURCE: ISO 11139:2018, 3.275, modified — Note 2 to entry has been added.]
3.65
sterilization
validated process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial 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.
[SOURCE: ISO 11139:2018, 3.277]
3.66
sterilization cycle
predetermined sequence of stages performed in a sterilizer to achieve product free of viable microorganisms
[SOURCE: ISO 11139:2018, 3.279]
3.67
sterilization process
series of actions or operations needed to achieve the specified requirements for sterility
Note 1 to entry: This series of actions includes pre-treatment of product (if necessary), exposure, under specified conditions, to the sterilizing agent and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or packaging operations that precede sterilization.
[SOURCE: ISO 11139:2018, 3.284]
3.68
sterilization temperature
minimum temperature on which the evaluation of the sterilization efficacy is based
[SOURCE: ISO 11139:2018, 3.286]
3.69
sterilizing agent
physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions
[SOURCE: ISO 11139:2018, 3.288]
3.70
temperature band
<moist heat sterilization> temperature range, the minimum of which is the sterilization temperature
Note 1 to entry: The upper limit of the temperature band can be specified in standards and/or can take into account product compatibility.
[SOURCE: ISO 11139:2018, 3.293.1, modified — Note 1 to entry added.]
3.71
test for sterility
technical operation defined in a pharmacopoeia performed on product following an aseptic process or exposure to a sterilization process
[SOURCE: ISO 11139:2018, 3.298]
3.72
test of sterility
technical operation performed as part of development, validation or requalification to determine the presence or absence of viable microorganisms on product or portions thereof
[SOURCE: ISO 11139:2018, 3.299]
3.73
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
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.
[SOURCE: ISO 11139:2018, 3.313]
3.74
verification
confirmation, through provision of objective evidence, that specified requirements have been fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations, monitoring or reviewing documents.
Note 2 to entry: The word “verified” is used to designate a corresponding status.
[SOURCE: ISO 11139:2018, 3.314]
3.75
works test
series of technical operations performed prior to delivery to demonstrate compliance of a piece of equipment with its specification
[SOURCE: ISO 11139:2018, 3.325]
3.76
z value
change in temperature of a thermal sterilization or disinfection process that produces a tenfold change in D value
Note 1 to entry: It is expressed in degrees Celsius (°C).
[SOURCE: ISO 11139:2018, 3.326]
30mm
10mm
15mm
15mm
10mm
17mm

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ICS 11.080.01
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iso.org

2 Under preparation. Stage at the time of publication: ISO/AWI 19253.