DIN EN 14180:2003-10
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
Available format(s)
Hardcopy , PDF
Superseded date
03-07-2021
Language(s)
English
Published date
01-01-2003
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National foreword
National Annex NA (informative) - Bibliography
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
Defines 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.
| DevelopmentNote |
Supersedes DIN 58948-12 E and DIN 58948-13 E. Together with DIN 58948-17, supersedes DIN 58948-15 E. (02/2004)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NEN EN 14180 : 2014 | Identical |
| NBN EN 14180 : 2014 | Identical |
| UNI EN 14180 : 2014 | Identical |
| SN EN 14180 : 2014 | Identical |
| I.S. EN 14180:2014 | Identical |
| EN 14180:2014 | Identical |
| BS EN 14180:2014 | Identical |
| NF EN 14180 : 2014 | Identical |
| NS EN 14180 : 2014 | Identical |
| UNE-EN 14180:2004 | 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 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements |
| DIN ISO 8787:1994-06 | TESTING OF PAPER AND BOARD - DETERMINATION OF CAPILLARY RISE - KLEMM METHOD |
| 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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