SIST EN 14065:2016

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Tekstilije - Tekstilije v postopku pranja - Sistem kontrole biokontaminacijeTextilien - In Wäschereien aufbereitete Textilien - Kontrollsystem BiokontaminationTextiles - Textiles traités en blanchisserie - Système de maîtrise de la biocontaminationTextiles - Laundry processed textiles - Biocontamination control system59.080.01Tekstilije na splošnoTextiles in general07.100.99Drugi standardi v zvezi z mikrobiologijoOther standards related to microbiologyICS:Ta slovenski standard je istoveten z:EN 14065:2016SIST EN 14065:2016en,fr,de01-julij-2016SIST EN 14065:2016SLOVENSKI
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SIST EN 14065:2016



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14065
May
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s v r x wã t r r tEnglish Version
Textiles æ Laundry processed textiles æ Biocontamination control system Textiles æ Textiles traités en blanchisserie æ Système de maîtrise de la biocontamination
Textilien æ In Wäschereien aufbereitete Textilien æ Kontrollsystem Biokontamination This European Standard was approved by CEN on
t t February
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egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä
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CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
9
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s v r x wã t r s x ESIST EN 14065:2016



EN 14065:2016 (E) 2 Contents Page European foreword . 4 Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 6 4 General principles and requirements . 9 4.1 Principles and framework . 9 4.2 General requirements . 10 5 Alignment with a quality management system . 10 6 Application of the Risk Analysis and Biocontamination Control system to laundries . 10 6.1 General . 10 6.2 Prerequisites and preliminary actions for establishing a RABC system . 10 6.2.1 Management commitment . 10 6.2.2 Constitution of the RABC team . 10 6.2.3 Prerequisites programme (PRP) . 11 6.2.4 Determination of the intended end use of the textile . 12 6.2.5 Preparation of laundry flow diagram(s) . 12 6.2.6 Process specification . 12 6.2.7 Training awareness and competency . 12 6.2.8 Purchasing information . 12 6.3 Application of the seven principles for implementing the RABC system. 12 6.3.1 General . 12 6.3.2 Principle 1: List of microbiological hazards and list of control measures . 12 6.3.3 Principle 2: Determine the Critical Control Points (CCPs) and Control Points (CPs) . 13 6.3.4 Principle 3: Establish the target levels and tolerance limits for each CCP . 13 6.3.5 Principle 4: Establish a monitoring programme for each CCP. 13 6.3.6 Principle 5: Establish corrective actions . 14 6.3.7 Principle 6: Establish the RABC system checking procedures . 14 6.3.8 Principle 7: Establish a documentation system . 15 Annex A (informative)
Rationale for application of RABC in laundries . 16 A.1 Introduction . 16 A.2 The process . 16 A.3 Variations in intended use . 16 A.4 Variations in market sector . 17 A.4.1 General . 17 A.4.2 Food sector . 17 A.4.3 Healthcare . 17 A.4.4 Cleanrooms . 17 Annex B (informative)
Examples of prerequisites . 18 B.1 General . 18 B.2 Premises and structures . 18 SIST EN 14065:2016



EN 14065:2016 (E) 3 B.3 Cleaning . 18 B.4 Personnel . 18 B.5 Equipment . 19 B.6 Foreign bodies and inappropriate materials . 19 B.7 Supplies . 19 B.8 Monitoring of PRP effectiveness . 19 Annex C (informative)
Examples and guidance for risk assessment . 20 Annex D (informative)
Control concepts illustration . 23 Annex E (informative)
Examples of wash process aspects . 24 Annex F (informative)
Examples of approaches to process validation for laundries . 25 F.1 General . 25 F.2 Introduction to Process Validation . 25 F.2.1 Overview . 25 F.2.2 Key to terms . 25 F.2.3 Process Validation Model for Laundries . 25 F.3 Considerations for developing validation plans . 26 F.3.1 Prior to validation . 26 F.3.2 Examples . 26 F.4 Guidance on basic validation elements . 27 F.4.1 General . 27 F.4.2 Use of historical data . 27 F.4.3 Performance Qualification (PQ) . 27 F.4.4 Operational Qualification (OQ) . 28 F.4.5 Installation Qualification (IQ) . 28 F.4.6 Design Qualification (DQ) . 28 F.5 Guidance on more developed validation elements . 28 F.5.1 Worst case challenge . 28 F.5.2 Experimental Design . 28 F.6 Parametric release . 29 Annex G (informative)
Synopsis of EN ISO 9001:2008 and EN 14065:2016 . 30 Bibliography . 34
SIST EN 14065:2016



EN 14065:2016 (E) 4 European foreword This document (EN 14065:2016) has been prepared by Technical Committee CEN/TC 248 “Textiles and textile products”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2016, and conflicting national standards shall be withdrawn at the latest by November 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14065:2002. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 14065:2016



EN 14065:2016 (E) 5 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 important in many sectors, e.g. healthcare, food, pharmaceutical and medical device, but biocontamination of processed textiles is not easily verified in the laundry, and can have significant effects on people, products, materials and environments. Where laundries provide textile services in such cases, the processed textiles should be suitable for the intended use. The purpose of this standard is to provide for a management system 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 standard 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 assure 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 to this standard therefore present examples and guidance to laundries. All annexes to this standard are informative only. They are neither intended nor suitable for specification or auditing. Annex A 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. Annex G provides cross references to EN ISO 9001 and to EN 14065:2016. 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. SIST EN 14065:2016



EN 14065:2016 (E) 6 1 Scope This European Standard describes a risk management approach, called Risk Analysis and Biocontamination Control (RABC), designed to enable laundries to continuously assure the microbiological quality of laundry processed textiles. The RABC approach applies for 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 Not applicable. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 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. 3.2 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 3.3 alert level established level of a CCP parameter set by the RABC team giving early warning of a change from normal conditions 3.4 biocontamination contamination with viable microorganisms, where contamination is the presence of an unwanted constituent, foreign to the textile 3.5 control measure action or activity used to prevent, contain, reduce or eliminate a biocontamination risk 3.6 control point (CP) point or process step at which a control measure is applied Note 1 to entry: Loss of control does not necessarily result in failure to meet acceptance criteria. Some control measures may not be applied at control points (e.g. cleaning, maintenance). 3.7 corrective action action to be taken, when the results of monitoring indicate that alert or action levels are exceeded, in order to restore control of the process SIST EN 14065:2016



EN 14065:2016 (E) 7 3.8 critical control point (CCP) any process step at which all of the following apply; control is essential to eliminate or reduce biocontamination risk, effective control is possible and is sufficient to achieve the acceptance criteria, no subsequent step can achieve the acceptance criteria 3.9 cross-contamination introduction of biocontamination to decontaminated textiles, directly or indirectly from contaminated textiles 3.10 decontamination process combining cleaning and sufficient microbial reduction for the intended purpose, e.g. disinfection 3.11 flow diagram graphical representation of the sequence and interaction of steps in a process 3.12 hazard in the context of this standard, any element or factor that may adversely affect the achievement of the agreed microbiological quality of textiles 3.13 laundry plant where soiled/used textiles undergo a laundering cycle (see 3.14) such that processed textiles are fit for their intended use 3.14 laundering cycle those process steps that textiles undergo in a laundry, between receipt from and hand over to the customer, including all or a combination of the following; sorting, classifying, washing, extraction, drying, finishing, folding, packing. 3.15 microbiological quality (of textiles) number and if required types of microorganisms present on textiles Note 1 to entry: The intended end-use will inform decisions on the agreed level of microbiological quality. 3.16 monitoring programme planned observations or measurements of control measures 3.17 parameter process or product characteristic which can be monitored and compared to an agreed range of values to indicate the current degree of control 3.18 prerequisites those facilities and practices relating to processing and hygiene that contribute significantly to effective implementation of a RABC system, including both enabling and control measures SIST EN 14065:2016



EN 14065:2016 (E) 8 3.19 processed textiles textiles which have undergone a laundering cycle 3.20 process validation providing objective evidence that a process operating within established parameters consistently produces a result or product that meets its pre-determined specifications 3.21 re-contamination introduction of biocontamination to decontaminated textiles from sources other than contaminated textiles 3.22 risk probability of a hazard occurring combined with the severity of the consequences. For this standard, consequences relate to the potential for adverse effects from processed textiles’ end use arising from biocontamination of the textile 3.23 risk analysis investigation of available information to identify hazards and to estimate the consequential risks 3.24 Risk Analysis and Biocontamination Control System (RABC system) management system for assuring processed textiles of appropriate microbiological quality according to their intended use 3.25 target level defined level for the parameters which are monitored at the critical control points (CCPs), generally established with action and alert levels 3.26 verification provision of objective evidence from operation of the monitoring programme to confirm that specified requirements have been fulfilled 3.27 viable microorganisms microorganisms capable of multiplying to produce demonstrable growth 3.28 washing operations taking place in a machine, in an aqueous medium, with the purpose of cleaning, decontaminating and conditioning the textile for further processing, e.g. wetting out, preliminary washing, washing, bleaching, decontaminating, neutralising, rinsing 3.29 washing supplies materials used in the wash process, e.g. for one or more of the following functions; textile decontamination, suspension of soiling and staining from textiles, providing residual benefit to textile after washing SIST EN 14065:2016



EN 14065:2016 (E) 9 4 General principles and requirements 4.1 Principles and framework The general principles of risk management provide an approach that is integral to business operation, addresses uncertainty, and is systematic and iterative and responsive to change. These principles are developed specifically for RABC in laundries as represented in Figure 1 below. Figure 1 identifies the clauses within this standard addressing the elements of the RABC model in order of implementation, with a key decision point after completion of risk assessment. The figure also shows how 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.
Key CP Control Point CCP Critical control point Figure 1 — Risk management and RABC SIST EN 14065:2016



EN 14065:2016 (E) 10 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 6. The RABC system shall include: — first, a prerequisites programme (PRP, see 6.2) focused on the work environment and good manufacturing practices — followed by a RABC plan, applying the seven RABC principles (see 6.3) 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. Annex A (informative) introduces a rationale and key issues for developing a RABC system in laundries. Annex B (informative) provides examples of prerequisites. 5 Alignment with a quality management system A RABC system, including the required documentation, can be integrated with a quality management system. 6 Application of the Risk Analysis and Biocontamination Control system to laundries 6.1 General The Risk Analysis and Biocontamination Control (RABC) system shall 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. 6.2 Prerequisites and preliminary actions for establishing a RABC system 6.2.1 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. 6.2.2 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 organisation 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; SIST EN 14065:2016



EN 14065:2016 (E) 11 — the quality team; — microbiological expertise as appropriate. 6.2.3 Prerequisites programme (PRP) 6.2.3.1 General The management shall provide and maintain the facilities and practices necessary to support the RABC system, including those which limit contamination from the work environment to the textile and cross-contamination and re-contamination after washing and drying. The RABC team shall implement and maintain the resulting PRP for general and operational considerations. Annex B (informative) provides examples of prerequisites. 6.2.3.2 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 (see 6.2.4 to 6.2.6); — personnel competence, training and hygiene (see 6.2.7); — purchased materials (see 6.2.8); — pest control. 6.2.3.3 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 (see 6.3 below), 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 (see 6.3); — control measure(s) and point(s) (CPs) for each microbiological hazard (particularl
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