oSIST prEN 14065:2026

SLOVENSKI STANDARD
01-april-2026
Tekstilije - Tekstilije, obdelane v pralnici - Sistem za nadzor biološke kontaminacije
Textiles - Laundry processed textiles - Biocontamination control system
Textilien - In Wäschereien aufbereitete Textilien - Kontrollsystem Biokontamination
Textiles - Textiles traités en blanchisserie - Système de maîtrise de la biocontamination
Ta slovenski standard je istoveten z: prEN 14065
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
59.080.01 Tekstilije na splošno Textiles in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2026
ICS 07.100.99; 59.080.01 Will supersede EN 14065:2016
English Version
Textiles - Laundry processed textiles - Biocontamination
control system
Textiles - Textiles traités en blanchisserie - Système de Textilien - In Wäschereien aufbereitete Textilien -
maîtrise de la biocontamination Kontrollsystem Biokontamination
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 248.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14065:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 5
3.1 Terms and definitions . 5
3.2 List of abbreviations . 9
4 General principles and requirements . 9
4.1 Principles and decision framework . 9
4.2 General requirements . 10
5 Application of the Risk Analysis and Biocontamination Control system to laundries
................................................................................................................................................................... 11
5.1 Prerequisites and preliminary actions for establishing a RABC system . 11
5.1.1 Management commitment . 11
5.1.2 Constitution of the RABC team . 11
5.1.3 Prerequisites programme (PRP) . 11
5.1.4 Determination of the intended end use of the textile . 12
5.1.5 Preparation of laundry flow diagram(s) . 12
5.1.6 Process specification . 12
5.1.7 Training awareness and competency . 13
5.1.8 Purchasing information . 13
5.2 Application of the seven principles for implementing the RABC system . 13
5.2.1 Principle 1: List of microbiological hazards and list of control measures . 13
5.2.2 Principle 2: Determine the Critical Control Points (CCPs) and Control Points (CPs) . 14
5.2.3 Principle 3: Establish the target levels and tolerance limits for each CCP . 14
5.2.4 Principle 4: Establish a monitoring programme for each CCP . 14
5.2.5 Principle 5: Establish corrective actions . 14
5.2.6 Principle 6: Establish the RABC system checking procedures . 15
5.2.7 Principle 7: Establish a documentation system . 16
Annex A (informative) Rationale for application of RABC in laundries . 17
Annex B (informative) Examples of prerequisites . 19
Annex C (informative) Risk assessments - Examples and guidance . 21
Annex D (informative) Control concepts illustration . 27
Annex E (informative) Examples of wash process aspects . 28
Annex F (informative) Examples of approaches to process validation for laundries . 29
Annex G (informative) Guidance on the Implementation of this document – RABC Systems
................................................................................................................................................................... 33
Bibliography . 37

European foreword
This document (prEN 14065:2026) has been prepared by Technical Committee CEN/TC 248 “Textiles
and textile products”, the secretariat of which is held by BSI.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14065:2016.
— An abbreviation list was added to the Clause 3, which was re-labelled “Terms, definitions and
abbreviations”
— Several figures have been replaced by text to allow for being translated
— The original Annex G was deleted and replaced by a new one. The new informative Annex G
— provides implementation guidance for users and auditors of the document
— includes a Clause Examples of useful standards and references to assist the implementation,
certification and auditing (G.3.4)
— The Bibliography has been updated
Introduction
The sensory cleanliness of processed textiles is important for the laundry industry and its customers.
Processed textiles should be visibly clean, free from stains and correctly dried or ironed; they should also
be pleasant to the touch and fragrant or at least free from any unpleasant odours, etc. In addition,
biocontamination control is critical in many sectors and contexts. Examples include pharmaceuticals,
medical devices, cleanrooms, surgical textiles, healthcare linen, food sector workwear and during public
health outbreaks. Biocontamination control is also important in sectors such as hospitality. Where
laundries provide textile services in such cases, the processed textiles should be suitable for the intended
use. Biocontamination of processed textiles is not easily verified in the laundry, and can have significant
effects on people, products, materials and environments.
The purpose of this document is to provide an approach that can effectively and consistently ensure
provision of processed textiles with a microbiological quality appropriate for the intended use.
Regardless of variations between laundries, processes or products, all textiles returning to a laundry for
processing are potentially contaminated. The objective of the laundering cycle is to achieve and then
maintain the appropriate microbiological quality to the point of handover to customer control.
The approach used in this document is to apply recognized risk and process management principles, and
to provide for a Risk Analysis and Biocontamination Control (RABC) system. The first core RABC element
is a general Prerequisite Programme (PRP) which includes the conditions and good manufacturing
practices necessary to achieve and maintain the hygiene of the work environment, process and textiles.
The second element is an operational PRP which includes the control measures that are most essential
for protecting washed, dried textiles from re-contamination and cross-contamination until they are
securely packed. The final RABC element is the seven RABC principles, which are applied to the most
capable and crucial process steps, called Critical Control Points (CCPs) wherein textiles are thoroughly
decontaminated. This can only be demonstrated through effective process validation. Where RABC
implementation is complete and current, laundries can then ensure all product released is suitable for its
intended use through ongoing monitoring and verification that enables identification and remedial action
for product from non-conforming processes.
The approach and the principles employed in RABC are similar to those used in the sectors named above,
e.g. Infection Control, Hazard Analysis And Critical Control Points (HACCP), Good Manufacturing
Practices (GMP). National and sector-specific guidance is available in many jurisdictions and can assist
RABC implementation.
Implementing RABC effectively in a laundry requires a sound understanding of the laundering process,
and of factors specific to the product/laundry/customer/sector/jurisdiction. The annexes and
specifically Annex G present examples and guidance to laundries for implementing and auditing their
RABC procedures. All annexes to this document are informative only. They are neither intended nor
suitable for specification or auditing. Annex A (informative) provides a description of the laundering
process and an introduction to some of the key related issues. Annexes B to F relate in more detail to
prerequisites, risk assessment, control measures, process parameters and validation approaches.
Implementing RABC is an iterative process. Review during implementation will identify different
strategies for controlling re-contamination in terms of investment, plant design, construction and
operation. Laundry operations and the market sector supplied will determine which is most appropriate.
Review will also determine where further development is appropriate.
1 Scope
This document describes a risk management approach, called Risk Analysis and Biocontamination
Control (RABC), designed to enable laundries to continuously ensure the microbiological quality of
laundry processed textiles. The RABC approach applies to laundry market sectors where it is necessary
to control biocontamination, e.g. pharmaceuticals, medical devices, food, healthcare and cosmetics. The
RABC approach excludes those aspects relating to worker safety and sterility of the final product.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviations
3.1 Terms 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/
3.1.1
microorganism
entity of microscopic size encompassing bacteria fungi protozoa and viruses
Note 1 to entry: Microbe is synonymous with microorganism.
3.1.2
acceptance criteria
required output from a process, specified quantitatively where possible, for particular product or process
characteristics
Note 1 to entry: Meeting acceptance criteria is the minimum requirement for product release.
3.1.3
action level
established level of a CCP parameter set by the RABC team at which remedial procedures are activated to
bring the laundry process back into control
3.1.4
alert level
established level of a CCP parameter set by the RABC team giving early warning of a change from normal
conditions
3.1.5
biocontamination
contamination with viable microorganisms (3.1.30), where contamination is the presence of an
unwanted constituent, foreign to the textile
3.1.6
control measure
action or activity used to prevent, contain, reduce or eliminate a biocontamination (3.1.5) risk
3.1.7
control point (CP)
point or process step at which a control measure (3.1.6) is applied
Note 1 to entry: Loss of control does not necessarily result in failure to meet acceptance criteria (3.1.2). Some
control measures (3.1.6) might not be applied at control points (e.g. cleaning, maintenance).
3.1.8
corrective action
action to be taken, when the results of monitoring indicate that alert or action levels (3.1.3) are exceeded,
in order to restore control of the process
3.1.9
critical control point (CCP)
critical, higher level control point (3.1.7) at which all of the following apply:
— control is essential to eliminate or reduce biocontamination (3.1.5) risk,
— effective control is possible and is sufficient to achieve the acceptance criteria (3.1.2),
— no subsequent step can achieve the acceptance criteria (3.1.2)
3.1.10
cross-contamination
introduction of biocontamination (3.1.5) to decontaminated textiles, directly or indirectly from
contaminated textiles
3.1.11
decontamination
process combining cleaning and sufficient microbial reduction for the intended purpose, e.g. disinfection
3.1.12
flow diagram
graphical representation of the sequence and interaction of steps in a process
3.1.13
hazard
in the context of this document, any element or factor that may adversely affect the achievement of the
agreed microbiological quality of textiles
3.1.14
laundry

facility where soiled/used textiles undergo a laundering cycle (3.1.15) such that processed textiles are fit
for their intended use
3.1.15
laundering cycle
process steps that textiles undergo in a laundry (3.1.14), between receipt from and hand over to the
customer, including all or a combination of the following: sorting, classifying, washing (3.1.31),
extraction, drying, finishing, folding, packing
3.1.16
microbiological quality
number and if required types of microorganisms (3.1) present on textiles
Note 1 to entry: The intended end-use will inform decisions on the agreed level of microbiological quality.
3.1.17
monitoring programme
planned observations or measurements of control measures (3.1.6)
3.1.18
parameter
process or product characteristic which can be monitored and compared to an agreed range of values to
indicate the current degree of control
3.1.19
prerequisites
facilities and practices relating to processing and hygiene that contribute significantly to effective
implementation of a RABC system, including both enabling and control measures (3.1.6)
3.1.20
processed textiles
textiles which have undergone a laundering cycle (3.1.15)
3.1.21
process validation
providing objective evidence that a process operating within established parameters (3.1.18)
consistently produces a result or product that meets its pre-determined specifications
3.1.22
qualification
an individual study or process challenge conducted as part of a validation plan
3.1.22.1
design qualification
DQ
documented verification that the proposed design of the facilities, systems and equipment is suitable for
the intended purpose
3.1.22.2
installation qualification
IQ
documented verification that the facilities, systems and equipment, as installed or modified, comply with
the approved design and the manufacturer’s recommendations
3.1.22.3
operational qualification
OQ
documented verification that the facilities, systems and equipment, as installed or modified, perform as
intended throughout the anticipated operating ranges
3.1.22.4
performance qualification
PQ
documented verification that the facilities, systems and equipment, as connected together, can perform
effectively and reproducibly, based on the approved process method and product specification
3.1.23
re-contamination
introduction of biocontamination (3.1.5) to decontaminated textiles from sources other than
contaminated textiles
3.1.24
re-validation
documented confirmation of an established validation, taking into account and documenting any interim
variations capable of impacting on process performance
3.1.25
risk
probability of a hazard (3.1.13) occurring combined with the severity of the consequences
Note 1 to entry: For this document, consequences relate to the potential for adverse effects from processed textiles’
(3.1.20) end use arising from biocontamination (3.1.5) of the textile.
3.1.26
risk analysis
investigation of available information to identify hazards (3.1.13) and to estimate the consequential risks
(3.1.25)
3.1.27
Risk Analysis and Biocontamination Control System
RABC system
industry recognised term for the management system for assuring processed textiles (3.1.20) of correct
microbiological quality (3.1.16) according to their intended use
Note 1 to entry: The risk assessment is undertaken to define the control system.
3.1.28
target level
defined level for the parameters (3.1.18) which are monitored at the critical control points (CCPs) (3.1.7),
generally established with action and alert levels (3.1.4)
3.1.29
verification
provision of objective evidence from operation of the monitoring programme (3.1.17) to confirm that
specified requirements have been fulfilled
3.1.30
viable microorganisms
microorganisms (3.1.1) capable of multiplying to produce demonstrable growth
3.1.31
washing
operation taking place in a machine, in an aqueous medium containing washing supplies (3.1.32), for the
purpose of cleaning, decontaminating and conditioning the textile
3.1.32
washing supplies
materials used in the wash process, e.g. for one or more of the following functions; textile
decontamination (3.1.11), suspension of soiling and staining from textiles, providing residual benefit to
textile after washing (3.1.31)
3.2 List of abbreviations
Abbreviation Full description
CCP Critical Control Point
CP Control Point
DQ Design Qualification
ED Experimental Design
GMP Good Manufacturing Practice
HACCP Hazard Analysis and Critical Control Points
NHS National Health Service (UK)
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
PRP Prerequisite Programme
QMS Quality Management System
RABC Risk Analysis and Biocontamination Control (system)
4 General principles and requirements
4.1 Principles and decision framework
The principles of risk management provide an approach that is integral to business operation, addresses
uncertainty, is systematic and iterative and responsive to change.
These principles are developed specifically for RABC in laundries. The RABC implementation process
identifies the clauses within this document addressing the elements of the RABC model in order of
implementation, with a key decision point after completion of risk assessment. The RABC model aligns
with generally accepted risk management practices.
Implementation is unlikely to be achieved in one attempt; it is a progressive, iterative process, which may
be broken down into smaller groups of activities which can be pursued concurrently or sequentially.
The RABC Implementation Process consists of the following stages:
a) Stages of Risk Management Process Assessment
1) General Requirements for Application of RABC
2) Define Prerequisites
3) Establish Management commitment
4) Structure the RABC Team
5) Determine Prerequisites programme and Operational CPs
6) Determine the intended use of the process
7) Establish a flow diagram to assist control communication
8) Define the process specification
9) Establish training procedures to achieve and verify competency
10) Define purchasing specifications and procurement controls
b) Stages of Risk Management Process Control
1) Implement the general principles
2) Identify the hazards
3) Analyse the risks
4) Determine the CCPs and the CPs and their impact on previous stages
c) Stages of Risk Management Process Review
1) Establish targets and tolerances
2) Address the monitoring system
3) Determine corrective actions
4) Review the process system
5) Address and review the process documentation
4.2 General requirements
The management shall establish, document, implement and maintain a RABC system to eliminate or
reduce the risks of textile biocontamination to the extent and type appropriate, according to the intended
use of the textiles. The required principles, methods and detailed controls are developed in Clause 5.
The RABC system shall include:
1) a prerequisites programme (PRP, see 5.1.3) providing for the work environment and good
manufacturing practices necessary to support a successful RABC system, including those which limit
contamination from the work environment to the textile and cross-contamination and re-
contamination after washing and drying;
2) a RABC plan that applies the seven RABC principles (see 5.2) to each critical process step or “critical
control point (CCP)”.
A PRP is less formal than the RABC plan but is an essential foundation and requirement for
implementation of a RABC system. The RABC system shall be regularly reviewed for currency and
effectiveness.
The Risk Analysis and Biocontamination Control (RABC) system will be implemented throughout the
laundering cycle and for other activities where the textiles remain under the laundry’s control; potentially
from collection through to delivery. Besides increasing the microbiological quality of textiles delivered to
the users, its benefit is to improve process management.
Annex A introduces a rationale and key issues for developing a RABC system in laundries with a quality
management system.
A RABC system, including the required documentation, can be integrated with a quality management
system.
5 Application of the Risk Analysis and Biocontamination Control system to
laundries
5.1 Prerequisites and preliminary actions for establishing a RABC system
5.1.1 Management commitment
The management shall provide evidence of its commitment to the development and the improvement of
the RABC system by establishing and documenting the scope of the RABC system and a RABC policy,
setting RABC objectives, conducting and recording management reviews and ensuring the availability of
necessary resources, particularly with respect to corrective actions.
5.1.2 Constitution of the RABC team
The management shall constitute a RABC team. The RABC team shall implement and maintain the RABC
system. This team shall be multidisciplinary with specific knowledge and experience appropriate to the
process considered and end product requirements. External resources may be employed, e.g. to provide
sufficient expertise.
NOTE A multidisciplinary team (depending on the organization of the laundry) could be drawn from:
—  different experience and seniority levels (e.g. manager, supervisor, operator);
—  production, engineering and distribution resources;
—  a representative of each section of the laundry;
—  a representative of the hygiene/cleaning team;
—  the quality team;
—  microbiological expertise as appropriate.
5.1.3 Prerequisites programme (PRP)
5.1.3.1 General prerequisites
General prerequisites relate to the facility and facility-wide practices. The programme shall address at
least the following elements, identifying the type of hazard to be controlled and the required conditions
and/or control measures for each element:
— construction, layout and maintenance of premises, buildings and associated facilities – particularly
production space and employee access facilities;
— cleaning/hygiene plans;
— water and steam systems – supply, storage, treatment and disposal;
— equipment suitability and control (e.g. cleaning, maintenance, calibration);
— control measures before decontamination and after packing, including handling, storage, packaging,
transport and re-work;
— personnel competence, training and hygiene;
— purchased materials;
— pest control.
Annex B (informative) provides examples of prerequisites.
5.1.3.2 Operational prerequisites
Operational prerequisites concern control measures applied to protect decontaminated textiles from re-
contamination and cross-contamination until they are packed. While individually these measures may
not meet the criteria for CCPs, cumulatively they are equally important and shall be competent to
maintain the microbiological quality of processed textiles. The operational prerequisites programme
shall specify requirements for at least the following:
— microbiological hazard(s) to be controlled;
— control measure(s) and point(s) (CPs) for each microbiological hazard (particularly from direct
contact surfaces such as packaging, equipment, hands);
— cleaning and decontamination as necessary for surfaces that directly contact processed textiles;
— monitoring programme and verifications sufficient to demonstrate all control measures are effective;
— corrections and corrective actions to be taken if monitoring shows that control has been
compromised;
— responsibilities and authorities for recording monitoring and interpreting results;
— record(s) of monitoring.
5.1.4 Determination of the intended end use of the textile
The intended use of any given textile is one of the most important factors to consider when applying the
RABC principles. Decisions affected include assessing risks, managing controls and agreeing final
microbiological quality levels with the customer. The RABC team shall identify and document the
intended end use of the textile taking into account requirements or specifications.
NOTE Requirements or specifications can originate with customers, sectors, National or European regulations,
ISO and CEN Standards.
5.1.5 Preparation of laundry flow diagram(s)
The RABC team shall develop, document and check the laundry flow diagram(s) that identifies the key
process steps and decisions and address the variations in processing related to product type, processing
route and intended use.
5.1.6 Process specification
The RABC team shall specify the process according to the type of textile and its intended use. Different
process specifications may be necessary depending on the nature of the soiling.
5.1.7 Training awareness and competency
The management shall:
a) identify awareness and competency needs for personnel performing activities affecting bio-
contamination, e.g. hygiene, product and material handling;
b) develop and maintain those competences, through training and other appropriate activities;
c) evaluate the effectiveness of competence development;
d) maintain appropriate records of education, training, qualifications, competence and experience.
5.1.8 Purchasing information
The RABC team shall identify materials that are bought in for use in the laundering cycle and that affect
the microbiological quality of processed textiles through contact, whether direct (e.g. packaging) or
indirect (e.g. surface disinfectants). Adverse effects can arise from the prior contamination of the material
(e.g. new textiles, packaging) or from the performance of the material (e.g. washing supplies). The RABC
team shall reference or include specifications for such materials in purchasing documentation and
demonstrate that they are suitable for their intended use.
5.2 Application of the seven principles for implementing the RABC system
5.2.1 Principle 1: List of microbiological hazards and list of control measures
5.2.1.1 Identification of the hazard(s) associated with the environment, process or product
The RABC team shall list all the microbiological hazards that can impact the microbiological quality of
textiles, addressing each step of the laundering cycle and other activities that are under the laundry’s
control.
5.2.1.2 Assessment of textile biocontamination risks
Risk assessment consists of analysis and evaluation of risks.
The RABC team shall carry out and document risk analysis for each hazard, deploying available evidence,
expertise and experience. For each risk identified, the probability of occurrence for related hazards and
the severity of consequences where the hazard occurs shall be identified and assessed, discriminating on
levels of risk. The consequence for end users from biocontamination of the processed textile shall be
described for each risk.
The RABC team shall evaluate documented risks, to identify and prioritize where control measures are
needed and to identify Critical Control Points (CCPs). When all RABC principles are addressed, the RABC
team shall revise the risk assessment to account for the impact of control measures as implemented.
Completed risk assessments shall also be reviewed, and revised as necessary, during subsequent
management review. More developed risk analysis techniques can be used where they incorporate the
above elements. Annex C (informative) provides examples and guidance for risk assessment.
5.2.1.3 Identification of control measures
The RABC team shall identify the control measures and further control measure to be developed where
necessary to achieve and maintain the appropriate microbiological quality. Control measures can be
listed by the process steps (e.g. at CPs) at which they are applied.
Control measures shall be implemented for each listed hazard. The RABC team shall establish and
document microbiological quality levels appropriate to the end-uses of the textiles. Annex D
(informative) provides examples of control measures.
NOTE Control measures correspond to actions and activities required to prevent, eliminate or reduce
biocontamination risks. More than one control measure might be needed to control a given risk. Several risks can
be controlled by the same control measure. Control measures can be general (e.g. laundry-wide) or specific to a
process step (i.e. CPs and CCPs).
5.2.2 Principle 2: Determine the Critical Control Points (CCPs) and Control Points (CPs)
The RABC team shall apply the definitions given in 3.1.5, 3.1.6, 3.1.8 of this document to identify,
document and treat each control measure as one of the following:
— Control measure – part of the general prerequisites programme;
— Control points (CPs) – part of the operational prerequisites programme;
— Critical Control Points (CCPs) – where all of the conditions explained in the definition (see 3.1.8)
apply.
5.2.3 Principle 3: Establish the target levels and tolerance limits for each CCP
The RABC team shall determine and document tolerance limits for normal operating conditions at each
CCP, including the rationale for the chosen limits, such that operation within these limits ensures
achievement of the agreed microbiological quality levels. Tolerance limits include measurable target,
alert and action levels.
5.2.4 Principle 4: Establish a monitoring programme for each CCP
The RABC team shall develop and document a monitoring programme for the observation of the normal
operating conditions of each CCP. The monitoring shall enable detection of any deviation from tolerance
limits. The monitoring programme shall supply this information in sufficient time for corrective action to
be taken to restore control of the laundry process and to deal with nonconforming textiles.
If deviations from normal operating conditions are detected (alert level), the monitoring programme
shall be intensified. If the action level is exceeded, corrective action shall be implemented as soon as the
condition becomes known.
The results of the monitoring programme shall be interpreted by a designated individual, possessing the
requisite expertise and authority to take corrective actions. If continuous monitoring is not possible, the
quantity and frequency of the monitoring programme shall be kept under review, but shall provide for
sufficient control of the CCP.
Most CCP monitoring should be capable of being performed in real time. Direct inspection is preferred
where the time required for long analytical tests is not available. Visual inspection and physical or
chemical measurements are preferred to microbiological analyses; their rapid implementation and the
results obtained should demonstrate that the conditions for controlling the microbiological
characteristics of the textiles have been maintained.
All recordings associated with CCP monitoring shall be authorized by the person(s) performing the
monitoring operations and by the designated person(s) responsible for interpreting the results.
5.2.5 Principle 5: Establish corrective actions
The RABC team shall develop and document the specific corrections and corrective actions which shall
be implemented for each CCP when the results of monitoring shows deviation from target levels and
tolerance limits. Action shall be taken as soon as the condition becomes known, in order to restore control
of the laundry process.
Monitoring shall be increased until it has been shown that target levels and tolerance limits for the CCP
have been met again. A decision shall also be required by the designated person on the disposition of
affected textiles e.g. remedial treatment. The reasons for corrective action and the decision on the
destination of textiles shall be documented.
5.2.6 Principle 6: Establish the RABC system checking procedures
5.2.6.1 Validation and re-validation of CCPs
5.2.6.1.1 General
Where a CCP has been established, the RABC team shall validate the related process.
Process validations shall establish and document at least the following:
— identify the processes to be validated;
— define the acceptance criteria for review and approval of such processes;
— directly verify process performance during validation. Retain and approve records of validation
methods and test results.
Annex F (informative) provides examples of approaches to process validation for laundries.
5.2.6.1.2 Microbial reduction
As verification of decontamination in the washing process in the available time is not possible, the
washing process shall be validated. For wash validations, the RABC team shall establish and document
the following:
— Identify the process parameters, targets and tolerances necessary for achieving decontamination [see
Annex E (informative)].
— Establish the acceptance criteria for successful completion of decontamination, in terms of process
capability for microbiologic reduction and of the microbiological quality of the processed textile.
— Confirm that the process operates within the identified process parameters.
— Verify that the control measures are sufficient to enable routine release of the product subsequent to
validation. E.g. equipment, detergent dosing and software.
— Using recognized microbiological test methods, demonstrate the capability of the process to
consistently achieve the established acceptance criteria.
NOTE See Bibliography for examples of microbiological methods. Microbial reduction can include removal
and/or inactivation of biocontamination. In some jurisdictions or applications, inactivation can be specified as
a requirement (e.g. medical devices).
— Re-validate at least every 12 months, or earlier where significant changes in process or product are
planned or as indicated by monitoring results as described in 5.2.4.
5.2.6.2 Review of the RABC system
The RABC team shall develop, implement and document regular reviews of the RABC system.
RABC reviews shall assess the currency, suitability and effectiveness of the RABC system, including at
least the following considerations:
— the RABC documentation, including policy and objectives;
— whether changes in facility, layout, equipment, procedures or laundry practice are necessary;
— whether changes as above shall require validation;
— the intended uses and flow diagrams for textiles;
— the alert and action levels and the related monitoring programme;
— incidents leading to deviations from target levels or tolerance limits or loss of control of the laundry
process;
— customer complaints or other market feedback concerning the microbiological quality of processed
textiles.
Agreed actions from the reviews shall be included in review records.
5.2.6.3 Internal audit
The management shall conduct periodic internal audits to determine whether the RABC system conforms
to the requirements of this document and has been effectively implemented and maintained.
5.2.7 Principle 7: Establish a documentation system
Effective documentation is essential for the proper implementation of the RABC system.
The documentation system shall comprise at least the following:
— Documentation of the Pre-requisites Programme (PRP), addressing 5.1.3 of this document;
— Documentation of the implementation of all RABC principles, addressing 5.2 of this document;
— Records arising from operation of the PRP and RABC plans, including from system reviews.
The extent of the documentation system shall be dependent on the following:
— size and type of the laundry;
— complexity of the processes;
— competence of personnel.
Annex A
(informative)
Rationale for application of RABC in laundries
A.1 Introduction
This annex focuses on the laundering cycle itself, and on considerations that affect implementation of
biocontamination control. Such issues include the role of laundering cycle stages in RABC terms,
variations in product intended use and variations within and between market sectors. Establishing the
capability of process stages, then capturing these variations and using subsequent risk analysis to decide
rationally on the appropriate level of control is the core of the RABC method. This approach allows for
great flexibility in the choice of solutions – in facility, processes and control measures. Subsequent
annexes develop issues raised here in further detail. Annex G provides specific guidance on how to
implement and audit RABC procedures in a laundry.
A.2 The process
As textiles are generally re-used, most laundering is part of a service involving collection of used items,
return to the laundry for laundering, then delivery to the customer. Laundries should operate sound
hygiene and good working practices throughout, but most effort in RABC implementation will be in the
laundry. For RABC purposes, three stages are recognized:
1) General: Laundries implement a comprehensive prerequisites programme, particularly for activities
and facilities before decontamination and after processed textiles are packed. The main focus is on
good practices and the prevention of cross-contamination and re-contamination. The prerequisites
support CP and CCP implementation (e.g. maintenance of process equipment). In this document, 5.1.3
and Annexes, B, D, E and G are the key references.
2) Decontamination: This is where the highest levels of performance and control are required, to be
achieved by applying the seven RABC principles. In this document, 5.2 and Annexes C, D, E and F are
the key references. The key to maximum effect from minimum cost and disruption is to prepare well
with effective prerequisite (PRP) implementation, i.e. identify the intended use clearly, map the
process simply to help show where control measures are most critical, and that effective process and
equipment control measures are in place.
3) Re-contamination and Cross-contamination: Once textiles have been decontaminated, the laundry
ensures that Re- and Cross-contamination does not occur, particularly up to the point where textiles
are packed. This is where the operational prerequisite programme applies, with control points that
individually are not critical, but which work together to protect textiles effectively. In this document,
5.2 and Annexes B, C and D are key references.
Note Concerning process capability, a well-engineered and operated wash process benefits from a well-
established interaction of time, temperature, mechanical and chemical factors, and is the only process capable of
achieving the appropriate microbiological quality for most textiles. The drying process can further decontaminate,
but less so than washing. The isolation of used(soiled) textiles before laundering is important to prevent cross
contamination and to inhibit the increase in biocontamination burden while stored.
A.
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