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BS EN 14180:2014

Current

Current

The latest, up-to-date edition.

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-05-2014

€303.84
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power and vibration
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test methods
Annex B (normative) - Sterilizer classification and testing
Annex C (normative) - Test equipment
Annex D (normative) - Determination of formaldehyde residuals
        in a filter indicator
Annex E (informative) - Formaldehyde residues on medical devices
Annex F (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on medical devices
Bibliography

Describes requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.

Committee
CH/198
DevelopmentNote
Supersedes 01/122182 DC. (10/2004) Supersedes 12/30262894 DC. (06/2014)
DocumentType
Standard
Pages
66
PublisherName
British Standards Institution
Status
Current
Supersedes

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

Standards Relationship
UNE-EN 14180:2004 Identical
NEN EN 14180 : 2014 Identical
NBN EN 14180 : 2014 Identical
UNI EN 14180 : 2014 Identical
SN EN 14180 : 2014 Identical
DIN EN 14180:2014-09 Identical
I.S. EN 14180:2014 Identical
EN 14180:2014 Identical
NF EN 14180 : 2014 Identical
NS EN 14180 : 2014 Identical
DIN EN 14180:2003-10 Identical

IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ISO 1874-1:2010 Plastics Polyamide (PA) moulding and extrusion materials Part 1: Designation system and basis for specification
EN 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
EN 10027-2:2015 Designation systems for steels - Part 2: Numerical system
EN 60584-2:1993 Thermocouples - Part 2: Tolerances
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN ISO 1874-1:2010 Plastics - Polyamide (PA) moulding and extrusion materials - Part 1: Designation system and basis for specification (ISO 1874-1:2010)
ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 1837:1999+A1:2009 Safety of machinery - Integral lighting of machines
IEC 60204-1:2016 Safety of machinery - Electrical equipment of machines - Part 1: General requirements
ISO 1762:2015 Paper, board and pulps Determination of residue (ash) on ignition at 525 degrees C
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 2758:2014 Paper Determination of bursting strength
ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
EN ISO 13732-1:2008 Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
EN ISO 228-1:2003 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)
EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
ISO 8787:1986 Paper and board — Determination of capillary rise — Klemm method
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
EN ISO 536:2012 Paper and board - Determination of grammage (ISO 536:2012)
EN ISO 3746:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
EN 60751:2008 INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
ISO 3781:2011 Paper and board — Determination of tensile strength after immersion in water
EN 62061:2005/A2:2015 SAFETY OF MACHINERY - FUNCTIONAL SAFETY OF SAFETY-RELATED ELECTRICAL, ELECTRONIC AND PROGRAMMABLE ELECTRONIC CONTROL SYSTEMS (IEC 62061:2005/A2:2015)
ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
ISO 536:2012 Paper and board Determination of grammage
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010)
EN ISO 2758:2014 Paper - Determination of bursting strength (ISO 2758:2014)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 13849-2:2012 Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
ISO 534:2011 Paper and board — Determination of thickness, density and specific volume
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
EN 14222:2003 Stainless steel shell boilers
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 534:2011 Paper and board - Determination of thickness, density and specific volume (ISO 534:2011)
1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
EN 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS

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