Name: PREN 17180 : DRAFT 2017
Brand: CEN

STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING

Published date

09-01-2018

Publisher

Comite Europeen de Normalisation

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Mechanical components and assemblies
5 Instrumentation, indicating and recording devices
6 Control systems
7 Performance requirements
8 Safety, Risk control and usability
9 Packaging, marking and labelling
10 Information to be supplied by the manufacturer
11 Services and local environment
Annex A (informative) - Sterilizer classification and test
        programme
Annex B (normative) - Test equipment
Annex C (normative) - Test loads
Annex D (normative) - Test procedures
Annex E (informative) - Measurement of hydrogen peroxide
Annex F (informative) - H2O2 residues on medical devices
Annex G (normative) - Protective measures
Annex H (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 93/42/EEC [OJ L 169] aimed to be
         covered
Bibliography

Gives requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.

Committee	TC 102
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
NEN EN 17180 : DRAFT 2018	Identical
17/30364306 DC : DRAFT DEC 2017	Identical
DIN EN 17180:2017-12 (Draft)	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
EN ISO 4287:1998/A1:2009	GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - TERMS, DEFINITIONS AND SURFACE TEXTURE PARAMETERS
EN 61508-3:2010	Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements
ISO 4287:1997	Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
EN ISO 14937:2009	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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
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 10216-5:2013	Seamless steel tubes for pressure purposes - Technical delivery conditions - Part 5: Stainless steel tubes
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
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
EN 10088-3:2014	Stainless steels - Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes
IEC 60204-1:2016	Safety of machinery - Electrical equipment of machines - Part 1: General requirements
EN ISO 10993-17:2009	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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 3740:2000	Acoustics Determination of sound power levels of noise sources Guidelines for the use of basic standards
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 2758:2014	Paper Determination of bursting strength
ISO 4017:2014	Fasteners Hexagon head screws Product grades A and B
EN 1717:2000	Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
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 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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 11135:2014	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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 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 ISO 11140-1:2014	Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
ISO 11140-1:2014	Sterilization of health care products Chemical indicators 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 2861:2013	Vacuum technology Dimensions of clamped-type quick-release couplings
AAMI RD47 : 2008	REPROCESSING OF HEMODIALYZERS
ISO 3781:2011	Paper and board — Determination of tensile strength after immersion in water
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
EN 60584-1:2013	Thermocouples - Part 1: EMF specifications and tolerances
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
EN ISO 3740:2000	ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES - GUIDELINES FOR THE USE OF BASIC STANDARDS
ISO 536:2012	Paper and board Determination of grammage
2014/68/EU : 2014 COR 1 2015	DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 MAY 2014 ON THE HARMONISATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE MAKING AVAILABLE ON THE MARKET OF PRESSURE EQUIPMENT TEXT WITH EEA RELEVANCE
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 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
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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
IEC 60584-1:2013	Thermocouples - Part 1: EMF specifications and tolerances
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 13060:2014	Small steam sterilizers
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)
EN 60204-1 : 2006 COR 2010	SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS