EN 14065:2016
(Main)Textiles - Laundry processed textiles - Biocontamination control system
Textiles - Laundry processed textiles - Biocontamination control system
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.
Textilien - In Wäschereien aufbereitete Textilien - Kontrollsystem Biokontamination
Diese Europäische Norm beschreibt einen als Risikoanalyse und Kontrollsystem Biokontamination (RABC) genannten Risikomanagementansatz, der darauf ausgelegt ist, Wäschereien in die Lage zu versetzen, die mikrobiologische Qualität der in der Wäscherei aufbereiteten Textilien kontinuierlich sicherzustellen. Der RABC-Ansatz gilt für Wäscherei-Marktsektoren, in denen die Lenkung der Biokontamination notwendig ist, z. B. in der Pharmaindustrie, bei der Herstellung von Medizinprodukten, Nahrungsmitteln und Kosmetika sowie im Gesundheitswesen. Der RABC-Ansatz schließt die mit der Sicherheit der Beschäftigten und der Sterilität des Endproduktes im Zusammenhang stehenden Aspekte aus.
Textiles - Textiles traités en blanchisserie - Système de maîtrise de la biocontamination
La présente Norme européenne décrit une approche de management des risques, appelée système d’analyse des risques et de maîtrise de la biocontamination (système RABC), conçue pour permettre aux blanchisseries de garantir en continu la qualité microbiologique des textiles traités en blanchisserie. L’approche RABC s’applique aux secteurs clients de la blanchisserie dans lesquels il est nécessaire de maîtriser la biocontamination, par exemple produits pharmaceutiques, dispositifs médicaux, agro-alimentaire, établissements de santé et produits cosmétiques. Elle ne couvre pas les aspects relatifs à la sécurité des travailleurs et à la stérilité du produit final.
Tekstilije - Tekstilije v postopku pranja - Sistem kontrole biokontaminacije
Ta evropski standard opisuje pristop obvladovanja tveganja, t.i. analizo tveganosti in nadzor biokontaminacije (RABC), s katerim lahko pralnice zagotovijo stalno mikrobiološko kakovost tekstilij v postopku pranja. Ta pristop se uporablja za tržne sektorje pralnic, v katerih je potreben nadzor biokontaminacije, npr. v farmacevtski industriji ter na področju medicinskih pripomočkov, živilske industrije, zdravstva in kozmetike. Pristop ne vključuje vidikov, ki zadevajo varnost delavcev in sterilnost končnega izdelka.
General Information
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Standards Content (Sample)
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
STANDARDSIST EN 14065:20031DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14065
May
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w {ä r z rä r s Supersedes EN
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
t r s xä
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
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
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
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
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
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