I.S. EN 13060:2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
SMALL STEAM STERILIZERS
Available format(s)
Hardcopy , PDF
Superseded date
01-23-2020
Superseded by
Published date
01-19-2015
Publisher
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety, risk control and usability
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) Clarification of the definition of hollow space A and hollow space B (see 3.18 and 3.30)
Annex B (informative) Process evaluation system
Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization
Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use
Annex E (informative) Load support systems
Annex F (informative) Rationale for the tests
Annex G (informative) Example of a process challenge device for narrow lumen
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices
Bibliography
Defines the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
| Committee |
CEN/TC 102
|
| DocumentType |
Test Method
|
| Pages |
82
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO prEN ISO 11140-6
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN 13060 : 2015 | Identical |
| NBN EN 13060 : 2015 | Identical |
| NEN EN 13060 : 2014 | Identical |
| NS EN 13060 : 2014 | Identical |
| UNE-EN 13060:2015 | Identical |
| ONORM EN 13060 : 2015 | Identical |
| SN EN 13060 : 2015 | Identical |
| UNI EN 13060 : 2010 | Identical |
| BS EN 13060 : 2014 | Identical |
| EN 13060:2014 | Identical |
| DIN EN 13060:2015-03 | 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 |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| EN ISO 9000:2005 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2005) |
| 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 |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| EN 13445-5 : 2014 COR 2017 | UNFIRED PRESSURE VESSELS - PART 5: INSPECTION AND TESTING |
| EN 61508-1:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements |
| ISO 4126-1:2013 | Safety devices for protection against excessive pressure — Part 1: Safety valves |
| EN 60584-2:1993 | Thermocouples - Part 2: Tolerances |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| EN 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| EN 60529:1991 | Degrees of protection provided by enclosures (IP Code) |
| EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN ISO 11138-3:2009 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| EN 764-1:2015+A1:2016 | Pressure equipment - Part 1: Vocabulary |
| EN ISO 11138-3:2017 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 13445-8:2014 | Unfired pressure vessels - Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys |
| 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 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 |
| 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 |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| 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 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 |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| 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 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 |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| 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) |
| 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 15223-1:2012 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012) |
| EN ISO 12100:2010 | Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010) |
| EN 61010-2-040:2005 | 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 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 |
| 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 |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| EN 285:2006+A2:2009 | Sterilization - Steam sterilizers - Large sterilizers |
| 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 |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 228-1:2000 | Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation |
| 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 10088-1:2014 | Stainless steels - Part 1: List of stainless steels |
| 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 |
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