1、August 2016 English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 07.100.99; 59.080.01!%Ylm“2547374
2、www.din.deDIN EN 14065Textiles Laundry processed textiles Biocontamination control system;English version EN 14065:2016,English translation of DIN EN 14065:2016-08Textilien In Wschereien aufbereitete Textilien Kontrollsystem Biokontamination;Englische Fassung EN 14065:2016,Englische bersetzung von D
3、IN EN 14065:2016-08Textiles Textiles traits en blanchisserie Systme de matrise de la biocontamination;Version anglaise EN 14065:2016,Traduction anglaise de DIN EN 14065:2016-08SupersedesDIN EN 14065:2003-02www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original
4、shall be considered authoritative.Document comprises 36 pages 08.16 2 A comma is used as the decimal marker. National foreword This document (EN 14065:2016) has been prepared by Technical Committee CEN/TC 248 “Textiles and textile products” (Secretariat: BSI, United Kingdom). The responsible German
5、body involved in its preparation was DIN-Normenausschuss Textil und Textil-maschinen (DIN Standards Committee Textiles and Textile Machinery), Working Committee NA 106-01-12 AA Industrielles Waschen/Biokontamination; SpA zu CEN/TC 248/WG 17 und ISO/TC 38/SC 2/WG 9. There is no DIN Standard available
6、 which corresponds to the International Standard referred to in this document. Amendments This standard differs from DIN EN 14065:2003-02 as follows: a) the entire standard has been revised to put laundries in the position to ensure the effective and consistent provision of processed textiles with a
7、n appropriate microbiological quality with the help of a Risk Analysis and Biocontamination Control (RABC) system; b) in Clause 3, new definitions for “acceptance criteria”, “control measure”, “control point”, “cross contamination”, “decontamination”, “prerequisites” and “process validation” have be
8、en added; c) Clause 4 has been restructured, and a figure showing the risk management process using an RABC system has been added; d) Clause 6 has been completely revised and restructured, and a new paragraph 6.2.3 “Prerequisites programme (PRP)” has been added; e) Annex A (informative) has been com
9、pletely revised and the title changed to “Rationale for application of RABC in laundries”; f) Annex B (informative) now includes “Examples of prerequisites”; g) Annex C (informative) now provides “Examples and guidance for risk assessment”; h) a new Annex D (informative) “Control concepts illustrati
10、on” has been added; i) a new Annex E (informative) “Examples of wash process aspects” has been added; j) a new Annex F (informative) “Examples of approaches to process validation for laundries” has been added; k) a new Annex G (informative) “Synopsis of EN ISO 9001:2008 and EN 14065:2016” has been a
11、dded; l) the Bibliography has been updated. Previous editions DIN EN 14065: 2003-02 DIN EN 14065:2016-08EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14065 May 2016 ICS 07.100.99; 59.080.01 Supersedes EN 14065:2002English Version Textiles - Laundry processed textiles - Biocontamination contro
12、l system Textiles - Textiles traits en blanchisserie - Systme de matrise de la biocontamination Textilien - In Wschereien aufbereitete Textilien - Kontrollsystem Biokontamination This European Standard was approved by CEN on 22 February 2016. CEN members are bound to comply with the CEN/CENELEC Inte
13、rnal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any
14、 CEN member. This European Standard exists 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 ve
15、rsions. CEN members are the national standards bodies of 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
16、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploita
17、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14065:2016 EEN 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 fr
18、amework . 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
19、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
20、. 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: Estab
21、lish 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 sys
22、tem 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) Exa
23、mples of prerequisites 18 B.1 General . 18 B.2 Premises and structures 18 DIN EN 14065:2016-08EN 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) E
24、xamples 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 Validati
25、on 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
26、 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 An
27、nex G (informative) Synopsis of EN ISO 9001:2008 and EN 14065:2016 . 30 Bibliography . 34 DIN EN 14065:2016-08 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
28、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
29、 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
30、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, Ne
31、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 14065:2016-08 EN 14065:2016 (E) 5 Introduction The sensory cleanliness of processed textiles is important for the laundry industry and its customers. Processed textiles
32、 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 dev
33、ice, 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
34、 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
35、 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,
36、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 texti
37、les. 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
38、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 suita
39、ble 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 Analys
40、is 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
41、 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
42、 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 R
43、ABC 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
44、 determine where further development is appropriate. DIN EN 14065:2016-08 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
45、 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
46、 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 No
47、te 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 p
48、arameter 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,
49、 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 DIN EN 1
