EN 14065:2016
Current
The latest, up-to-date edition.
05-25-2016
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles and requirements
5 Alignment with a quality management system
6 Application of the Risk Analysis and Biocontamination
Control system to laundries
Annex A (informative) - Rationale for application of RABC
in laundries
Annex B (informative) - Examples of prerequisites
Annex C (informative) - Examples and guidance for risk
assessment
Annex D (informative) - Control concepts illustration
Annex E (informative) - Examples of wash process aspects
Annex F (informative) - Examples of approaches to process
validation for laundries
Annex G (informative) - Synopsis of EN ISO 9001:2008 and
EN 14065:2016
Bibliography
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.
| Committee |
CEN/TC 248
|
| DevelopmentNote |
Supersedes PREN 14065. (05/2016)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNI EN 14065:2016 | Identical |
| UNE-EN 14065:2017 | Identical |
| NBN EN 14065 : 2016 | Identical |
| NS EN 14065 : 2002 | Identical |
| I.S. EN 14065:2016 | Identical |
| NF EN 14065 : 2016 | Identical |
| SN EN 14065 : 2016 | Identical |
| PN EN 14065 : 2016 | Identical |
| DIN EN 14065:2016-08 | Identical |
| BS EN 14065:2016 | Identical |
| UNI EN 14065 : 2004 | Identical |
| NEN EN 14065 : 2016 | Identical |
| S.R. CEN/TS 14237:2015 | TEXTILES FOR HEALTHCARE AND SOCIAL SERVICES FACILITIES |
| I.S. EN 13795:2011 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| 17/30358661 DC : 0 | BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| CEN/TS 14237:2015 | Textiles for healthcare and social services facilities |
| PREN 13795-1 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| BS EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| DIN EN 13795:2013-10 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| DIN CEN/TS 14237;DIN SPEC 32988:2016-04 | TEXTILES FOR HEALTHCARE AND SOCIAL SERVICES FACILITIES |
| UNI EN 13795 : 2013 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| UNI EN 13795-1 : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| 09/30190221 DC : 0 | BS EN 13795 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| DIN CEN/TS 14237;DIN SPEC 32988:2016-04 | Textiles for healthcare and social services facilities; English version CEN/TS 14237:2015 |
| UNE-EN 13795:2011 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| DIN EN 13795-1 E : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| 17/30329441 DC : 0 | BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| PREN 13795-2 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| 17/30358658 DC : 0 | BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| DIN EN 13795-1:2009-10 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| EN 13569:2001 | Cabinet roller towels - Performance requirements and processing |
| EN ISO 14698-1 : 2003 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| ISO 22000:2005 | Food safety management systems Requirements for any organization in the food chain |
| ISO 20743:2013 | Textiles Determination of antibacterial activity of textile products |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 31000:2009 | Risk management Principles and guidelines |
| EN ISO 22000:2005 | Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2005) |
| EN ISO 20743:2013 | TEXTILES - DETERMINATION OF ANTIBACTERIAL ACTIVITY OF TEXTILE PRODUCTS (ISO 20743:2013) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 16616:2015 | Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2) |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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