SIST 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
Relations
Overview
EN 14065:2016 - "Textiles - Laundry processed textiles - Biocontamination control system" (CEN) specifies a risk-based management framework, called Risk Analysis and Biocontamination Control (RABC), to enable laundries to continuously assure the microbiological quality of processed textiles. The standard targets market sectors where control of biocontamination is critical (e.g., healthcare, food, pharmaceuticals, medical devices, cosmetics) and explicitly excludes worker safety and sterility of the final product.
Key Topics
- RABC framework: A systematic, iterative approach combining a general Prerequisite Programme (PRP), an operational PRP, and the seven RABC principles applied to critical processing steps.
- Risk assessment and control: Identification of microbiological hazards, selection of Control Points (CPs) and Critical Control Points (CCPs), and definition of control measures.
- Process parameters: Establishing target levels, tolerance limits, alert and action levels for CCPs and CPs.
- Monitoring and corrective action: Ongoing monitoring programs, documented corrective actions, and verification procedures to maintain control.
- Validation: Process validation requirements for proving effective decontamination (Annex F references Installation, Operational and Performance Qualification (IQ/OQ/PQ) approaches).
- Prerequisites and implementation: Practical prerequisites (premises, cleaning, personnel, equipment, supplies), laundry flow diagrams, process specifications, training and purchasing information (Annexes A–E provide guidance).
- Quality alignment and documentation: Guidance on integrating RABC with a quality management system (see clause on alignment and Annex G). All annexes are informative and not intended as normative audit checklists.
Applications
Who uses EN 14065:2016:
- Commercial and industrial laundries serving healthcare, food service, pharmaceutical, medical device, and cosmetic sectors
- Quality managers, compliance officers and auditors seeking to document microbiological control of textiles
- Procurement teams specifying microbiological requirements for textile services
- Regulatory consultants advising on hygiene and contamination control in laundry operations
Practical benefits:
- Consistent, demonstrable control of biocontamination risks in processed textiles
- Framework for process validation and ongoing verification to assure suitability for intended use
- Improved customer confidence through documented monitoring, corrective action and traceability
Related standards
- EN 14065:2016 aligns with general quality management principles and includes a synopsis with EN ISO 9001 (see Annex G). It supersedes earlier versions (EN 14065:2002). For sector-specific compliance (healthcare, food, pharmaceuticals), refer to applicable national and sector guidance in addition to EN 14065:2016.
Keywords: EN 14065:2016, RABC, biocontamination control system, laundry, textiles, microbiological quality, Critical Control Points, process validation, healthcare laundry, food industry laundry.
Frequently Asked Questions
SIST EN 14065:2016 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Textiles - Laundry processed textiles - Biocontamination control system". This standard covers: 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.
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.
SIST EN 14065:2016 is classified under the following ICS (International Classification for Standards) categories: 07.100.99 - Other standards related to microbiology; 59.080.01 - Textiles in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 14065:2016 has the following relationships with other standards: It is inter standard links to SIST EN 14065:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN 14065:2016 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
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
t r s x ICS
r yä s r rä { {â
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
Key CP Control Point CCP Critical control point Figure 1 — Risk management and RABC SIST EN 14065:2016
Rationale for application of RABC in laundries A.1 Introduction The Introduction to this standard speaks of applying biocontamination control to laundries in general. This annex focuses attention 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. 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 plant. Related terms (e.g. laundering cycle) are defined in Clause 3 of the standard. For RABC purposes, three stages are recognised: General: The laundry should implement a plant-wide prerequisites programme, particularly for activities and facilities before decontamination and after processed textiles are packed. The main focus is on good practices, and prevention of cross-contamination and re-contamination. The prerequisites should also support CP and CCP implementation (e.g. maintenance of process equipment). In this standard, 6.2 (particularly 6.2.3.2) and Annexes, B, D and E are the key references Decontamination: This is where the highest levels of performance and control are required, to be achieved by applying the seven RABC principles. In this standard, 6.3 and Annexes C, D, E and F are the key references. The key to maximum effect from minimum cost & 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, ensure effective process and equipment control measures are in place. Re-contamination and Cross-contamination: O
...
The article discusses the European Standard called SIST EN 14065:2016, which focuses on controlling biocontamination in laundry processed textiles. The standard outlines a risk management method called Risk Analysis and Biocontamination Control (RABC), which allows laundries to ensure the microbiological quality of their textiles. The RABC approach is especially important in industries like pharmaceuticals, medical devices, food, healthcare, and cosmetics. However, worker safety and product sterility are not addressed in this standard.
記事のタイトル: SIST EN 14065:2016 - テキスタイル - 洗濯加工されたテキスタイル - 生物汚染制御システム 記事の内容: この欧州規格は、テキスタイルの洗濯加工において微生物の品質を継続的に保証するために開発されたリスク分析と生物汚染制御(RABC)というリスク管理手法について説明しています。RABCの手法は、製薬、医療機器、食品、医療、化粧品など、生物汚染制御が必要な洗濯市場のセクターに適用されます。ただし、労働者の安全性や最終製品の無菌性に関連する側面は考慮されていません。
기사 제목: SIST EN 14065:2016 - 섬유 - 세탁 처리된 섬유 - 생물 오염 제어 시스템 기사 내용: 이 유럽 표준은 세탁 처리된 섬유의 미생물 품질을 지속적으로 보장하기 위해 개발된 위험 관리 접근 방식인 리스크 분석 및 생물 오염 제어(RABC)를 설명한다. RABC 접근 방식은 생물 오염을 통제해야 하는 세탁시장 부문(제약, 의료기기, 식품, 보건의료 및 화장품 등)에 적용된다. 그러나 RABC 접근 방식은 작업자 안전과 최종 제품의 살균성과 관련된 측면은 제외된다.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...