DIN EN 13060:2015-03
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
SMALL STEAM STERILIZERS
Hardcopy , PDF
07-03-2021
German, English
01-01-2015
National foreword
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 narrow lumens and simple hollow items
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
This standard is included in DIN Handbook 169.
DevelopmentNote |
Supersedes DIN EN 13060-1, DIN EN 13060-2, DIN EN 13060-3 and DIN EN 13060-4. (05/2002) Supersedes DIN 58946-5 and DIN 58946-8. (09/2004) DRAFT AMD 1 issued in November 2017. (11/2017)
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DocumentType |
Standard
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Pages |
83
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PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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Status |
Superseded
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Supersedes |
Standards | Relationship |
ONORM EN 13060 : 2015 | Identical |
SN EN 13060 : 2015 | Identical |
NF EN 13060 : 2015 | Identical |
EN 13060:2014 | Identical |
BS EN 13060 : 2014 | Identical |
NEN EN 13060 : 2014 | Identical |
NS EN 13060 : 2014 | Identical |
UNI EN 13060 : 2010 | Identical |
UNE-EN 13060:2015 | Identical |
NBN EN 13060 : 2015 | Identical |
I.S. EN 13060:2014 | Identical |
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DIN 19403:2016-08 | DENTISTRY - MULTIFUNCTION HANDPIECES |
DIN HDBK 169 : 6ED 2015 |
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 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 |
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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) |
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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 |
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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 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) |
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) |
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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