Textiles - Laundry processed textiles - Biocontamination control system

This draft European Standard describes a system for ensuring the microbiological quality of laundry processed textiles used in specifically defined sectors in which it is necessary to control biocontamination. This document describes a Risk Analysis and biocontamination Control (RABC) system in laundries in order to continuously assure the microbiological quality of the laundered textiles.

Textilien - In Wäschereien aufbereitete Textilien - Kontrollsystem Biokontamination

Dieser Europäische Norm-Entwurf legt ein System zur Kontrolle der mikrobiologischen Qualität von Textilien während der Aufbereitung fest, die in definierten Bereichen zum Einsatz kommen, in denen eine Kontrolle der Biokontamination notwendig ist. Diese Norm beschreibt eine Risikoanalyse und ein Kontrollsystem Biokontamination (RABC) in Wäschereien, um eine definierte mikrobiologische Qualität aufbereiteter Textilien sicherzustellen.
Diese Norm gilt für Wäschereien, die Textilien aus speziellen Bereichen aufbereiten, z. B. der Pharmaindustrie, der Herstellung von Medizinprodukten, Nahrungsmitteln und Kosmetika sowie im Gesundheitswesen benutzt werden. Diese Norm gilt nicht für die Sicherheit der Beschäftigten und die Sterilität des Endproduktes.

Textiles - Textiles traités en blanchisserie - Systeme de maîtrise de la biocontamination

La présente Norme européenne décrit un systeme de management permettant d'assurer la qualité microbiologique des textiles traités en blanchisserie utilisés dans des secteurs spécifiquement définis dans lesquels la maîtrise de la biocontamination est nécessaire. Le présent document décrit un systeme d'analyse du risque et de maîtrise de la biocontamination (RABC) en blanchisserie pour permettre d'assurer continuellement la qualité microbiologique des textiles traités.
Le présent projet s'applique aux textiles traités en blanchisserie et utilisés dans des secteurs spécifiques : produits pharmaceutiques, établissements de santé, alimentation, produits de soin, cosmétiques ; il ne couvre pas les aspects relatifs a la sécurité des travailleurs ni a la stérilité du produit final.

Tekstilije - Tekstilije v postopku pranja - Sistem kontrole biokontaminacije

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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 - Systeme 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 14065:2002SIST EN 14065:2003en01-februar-2003SIST EN 14065:2003SLOVENSKI

SIST EN 14065:2003

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14065November 2002ICS 07.100.99; 59.080.01English versionTextiles - Laundry processed textiles - Biocontamination controlsystemTextiles - Textiles traités en blanchisserie - Système demaîtrise de la biocontaminationTextilien - In Wäschereien aufbereitete Textilien -Kontrollsystem BiokontaminationThis European Standard was approved by CEN on 23 September 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14065:2002 ESIST EN 14065:2003

EN 14065:2002 (E)2ContentspageForeword.3Introduction.41Scope.62Normative references.63Terms and definitions.64Prerequisites and general principles of biocontamination control.85Alignment with a quality management system.96Application of the Risk Analysis and Biocontamination Control system to laundries.9Annex A (informative)
Examples of good manufacturing prerequisites for biocontamination control.14Annex B (informative)
Examples of microbiological hazards.16Annex C (informative)
Examples of control measures.17Bibliography.19SIST EN 14065:2003

EN 14065:2002 (E)3ForewordThis document EN 14065:2002 has been prepared by Technical Committee CEN /TC 248 "Textiles and textileproducts", 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 orby endorsement, at the latest by May 2003, and conflicting national standards shall be withdrawn at the latest byMay 2003.Annexes A, B and C are informative.This document contains a bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN 14065:2003

EN 14065:2002 (E)4IntroductionGeneralThe sensory cleanliness of laundry processed textiles is important for the laundry industry and their customers.Processed textiles should be visibly clean, free from stains and correctly dried or ironed; they should also bepleasant to the touch and fragrant or at least free from any unpleasant odours, etc.Sensory cleanliness is obtained during the laundry cycle through physico-chemical treatments such as mechanicalaction, temperature, addition of detergents and auxiliary products, bleaching agents, dilutions and rinses insuccessive baths, in combination with sufficient time. With these procedures, most micro-organisms have a lowprobability of survival.Nowadays the need for the prevention of microbiological contamination of individuals, products, materials orenvironment is of increasing significance. Consequently, assured microbiological quality becomes necessary.Therefore the laundry industry is adopting new process control techniques to assure the microbiological quality oflaundered textiles.The purpose of this standard is to provide a management system to deliver an agreed level of microbiologicalquality according to the intended use of the textile.The microbiological quality of textiles is determined by their intended use, e.g. consistent with the level of risk forindividuals, products, materials or an environment exposed to biocontamination. In certain cases, where very highmicrobiological quality is required, for example in operating theatres and immune-deficiency or burns departmentsin hospitals, etc., processing is completed by sterilisation.Soiled textiles entering a laundry are contaminated with varying numbers of micro-organisms from the environmentin which they have been used. In this context, the objective of the launderer is to decontaminate the textiles using adisinfecting process and then protect them from subsequent recontamination up to the moment they become theresponsibility of the customer.Good manufacturing practice in the laundry is a prerequisite for achieving microbiological quality; some countriesalready possess national guidelines to assist with this.Working practices for dealing with hazards and controlling risks prior to washing should be common to all laundryoperations. However from the point of maximum decontamination (by thermal, chemical and physical means) thetextiles will be subject to microbiological recontamination. The awareness of a ‘micro-organism exchange’ isimportant in assessing the impact recontamination may have in the use of the textile.Different strategies are used for controlling recontamination in terms of investment, plant design, construction andoperation. Laundry operations and the market sector they supply will determine which is most appropriate.The true performance of the complete laundry processes may only be validated after adequate in-processmicrobiological testing has been carried out. It may be necessary to modify plant lay out and revalidate processesas a result.This document has been developed using the principles of a Risk Analysis and Biocontamination Control (RABC)system, presented in prEN ISO 14698–1. This method is essentially based on preventative measures, as opposedto inspection procedures on the end product.This standard does not take into account the measures required for the protection of personnel.SIST EN 14065:2003

EN 14065:2002 (E)5Process approachThis European Standard, which describes a process approach to quality management, is consistent with ISO9001:2000, except clause 7.3 (according to permissible exclusions given in 1.2 of ISO 9001:2000).In the RABC system, a risk analysis has been added to a quality assurance process.Compatibility with other quality management systemsThis European Standard is compatible with other internationally recognised quality management system standards.This European Standard may be integrated into an existing quality management system.SIST EN 14065:2003

EN 14065:2002 (E)61 ScopeThis European Standard describes a management system for ensuring the microbiological quality of laundryprocessed textiles used in specifically defined sectors in which it is necessary to control biocontamination. Thisdocument describes a Risk Analysis and Biocontamination Control (RABC) system to enable laundries tocontinuously assure the microbiological quality of the laundered textiles.It applies to textiles processed in laundries and used in specific sectors, e.g. pharmaceuticals, medical devices,food, healthcare and cosmetics and excludes those aspects relating to worker safety and sterility of the finalproduct.2 Normative referencesNot applicable.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1action levelestablished level of a CP monitoring variable set by the RABC team at which remedial procedures are activated tobring the laundry process back into control3.2alert levelestablished level of a CP monitoring variable set by the RABC team giving early warning of a change from normalconditions3.3biocontaminationcontamination with viable micro-organisms3.4control measureaction or procedure required to control a biocontamination risk3.5control point (CP)any point or step in a process at which control is applied in order to contain, eliminate or reduce biocontaminationrisk3.6corrective actionaction to be taken, when the results of monitoring indicate that alert or action levels are exceeded, in order torestore control of the process3.7flow diagramgraphical representation of all the steps in the process3.8hazardin the context of this standard, any element or factor that may adversely affect the achievement of the agreedmicrobiological quality of textilesSIST EN 14065:2003

EN 14065:2002 (E)73.9laundryplant where soiled/used textiles are given an appropriate series of processes, e.g. washing, drying/finishing, ironingfolding and packing, in order to deliver these articles fit for reuse3.10laundering cycleall or a combination of the following operations carried out firstly in a machine, in an aqueous medium, wetting out,preliminary washing, washing, bleaching, rinsing, neutralisation followed by extraction, drying, finishing, folding,packing3.11microbiological quality (of textiles)number and if required types of micro-organisms present on textilesNOTEThe intended end-use will determine the agreed level of microbiological quality.3.12monitoring programmeidentification of the variables to be monitored at the control points, together with the frequency of observation3.13processed textilestextiles which have undergone a laundry cycle3.14RABC logbookchronicle of all monitoring data, observations and actions taken and their consequences3.15RABC manualrecord of all the administrative and implementation documentation for the RABC system3.16risklikelihood of a harmful effect occurring as a consequence of a hazard3.17risk analysisinvestigation of available information to identify hazards and to estimate the consequential risks3.18Risk Analysis and Biocontamination Control System (RABC system)quality management system with an additional risk analysis for the control of risks of biocontamination of laundryprocessed textiles3.19target leveldefined level for the variables which shall be monitored at the control points3.20viable micro-organismsisolated, naturally occurring or accumulated micro-organisms capable of multiplying to produce demonstrablegrowth3.21washing suppliesproducts used in the machine during washing to assist the removal of soiling and stains and keep them insuspension in an aqueous mediumNOTE
These include in particular soaps and surface-active agents, complexing agents, alkaline products and bleaching agents.SIST EN 14065:2003

EN 14065:2002 (E)84 Prerequisites and general principles of biocontamination controlIt is necessary for a laundry to follow good manufacturing practices as a prerequisite to implementing this standard.These can form part of an existing quality management system.Examples of the topics to be considered are given in annex A.A formal system shall be established, implemented and maintained in order to assess and control risks that canaffect the microbiological quality of the process and product.In such a system, specific microbiological hazards shall be identified. The control measures and their effectivenessshall be determined, analysed and documented.The principles of a Risk Analysis and Biocontamination Control system (RABC) are :4.1 Principle 1 : List of microbiological hazards and list of control measuresa) Identification of the microbiological hazard(s) associated with each step of the process, with the product or withstaff ;b) assessment and classification of levels of risk(s) of biocontamination of textiles at each step of the process as aconsequence of the hazard ;NOTEClassification of risk(s) can be performed according to relevant national guidelines or regulations where these exist.c) identification of control measures to eliminate or reduce the risk(s) of biocontamination of textiles to reach theagreed microbiological quality for the end-use of the textiles.4.2 Principle 2 : Determination of the control pointsDetermination of the points/steps/environmental conditions that can be controlled (control points) to eliminate orreduce the risk(s).4.3 Principle 3 : Target levels and limits - TolerancesEstablishment of limits at each control point which shall not be exceeded to assure microbiological quality oftextiles.4.4 Principle 4 : Monitoring systemEstablishment of scheduled testing or observation to monitor the control points.4.5 Principle 5 : Corrective actionsEstablishment of corrective actions to be taken when monitoring indicates that a particularpoint/procedure/operational step/environmental condition is not under control.4.6 Principle 6 : RABC System checking proceduresEstablishment of procedures to verify that the system is working effectively.4.7 Principle 7 : DocumentationEstablishment and maintenance of appropriate documentation.SIST EN 14065:2003

EN 14065:2002 (E)95 Alignment with a quality management systemIn order to improve efficiency and reduce the amount of documentation required, the documentation of the RABCsystem in accordance with 6.2.7 can be integrated with that of the existing compatible quality management system6 Application of the Risk Analysis and Biocontamination Control system to laundriesThe Risk Analysis and Biocontamination Control (RABC) system shall be used throughout the entire textilelaundering process, from collection of the soiled articles to delivery of articles fit for use. Besides increasing themicrobiological quality of textiles delivered to the users, its advantage is to improve process management.Prerequisites and several preliminary actions are required for implementation of the RABC system to the laundry(6.1) before applying the seven p

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