DIN EN 285:2016-05
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization - Steam sterilizers - Large sterilizers
Available format(s)
Hardcopy , PDF
Superseded date
28-01-2022
Superseded by
Language(s)
English, German
Published date
01-05-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.| DevelopmentNote |
Supersedes DIN 58946-2 and -3. (08/2002) Supersedes DIN 58946-7 issue 08-1982. (09/2004)
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| DocumentType |
Standard
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| Pages |
106
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| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 285:2016 | Identical |
| NEN EN 285 : 2016 | Identical |
| SN EN 285 : 2016 | Identical |
| NS EN 285 : 2015 | Identical |
| EN 285:2015 | Identical |
| BS EN 285:2015 | Identical |
| NBN EN 285 : 2016 | Identical |
| NF EN 285 : 2016 | Identical |
| I.S. EN 285:2015 | Identical |
| UNI EN 285 : 2009 | Identical |
| ONORM EN 285 : 2016 | Identical |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| VDI 2050 Blatt 4:2011-11 | Requirements for mechanical equipment rooms - Ventilation and air-conditioning |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| VDI 2083 Blatt 7:2015-10 | Cleanroom technology - Ultrapure media - Quality, supply, distribution |
| DIN 58946-6:2002-04 | STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES |
| 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/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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) |
| EN 547-2:1996+A1:2008 | Safety of machinery - Human body measurements - Part 2: Principles for determining the dimensions required for access openings |
| 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 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 |
| EN ISO 11140-3:2009 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
| ISO 13408-2:2003 | Aseptic processing of health care products Part 2: Filtration |
| 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 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 |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| IEC 60204-1:2016 | Safety of machinery - Electrical equipment of machines - Part 1: General requirements |
| ISO 14738:2002 | Safety of machinery — Anthropometric requirements for the design of workstations at machinery |
| EN 547-1:1996+A1:2008 | Safety of machinery - Human body measurements - Part 1: Principles for determining the dimensions required for openings for whole body access into machinery |
| EN 764-1:2015+A1:2016 | Pressure equipment - Part 1: Vocabulary |
| 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 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 |
| ISO 11140-3:2007 | Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| EN 10088-2:2014 | Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes |
| ISO 12100:2010 | Safety of machinery — General principles for design — Risk assessment and risk reduction |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 13445-8 : 2014 COR 2017 | UNFIRED PRESSURE VESSELS - PART 8: ADDITIONAL REQUIREMENTS FOR PRESSURE VESSELS OF ALUMINIUM AND ALUMINIUM ALLOYS |
| 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) |
| ISO 8573-1:2010 | Compressed air Part 1: Contaminants and purity classes |
| 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 13445-4 : 2014 COR 2017 | UNFIRED PRESSURE VESSELS - PART 4: FABRICATION |
| 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 |
| ISO 11140-4:2007 | Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
| 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 |
| EN 22768-1:1993 | General tolerances - Part 1: Tolerances for linear and angular dimensions without individual tolerance indications (ISO 2768-1:1989) |
| EN 60584-1:2013 | Thermocouples - Part 1: EMF specifications and tolerances |
| EN 547-3:1996+A1:2008 | Safety of machinery - Human body measurements - Part 3: Anthropometric data |
| 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) |
| EN 61032:1998 | Protection of persons and equipment by enclosures - Probes for verification |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN ISO 3740:2000 | Acoustics - Determination of sound power levels of noise sources - Guidelines for the use of basic standards (ISO 3740:2000) |
| 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 11140-4:2007 | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007) |
| 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 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| EN ISO 14050:2010 | Environmental management - Vocabulary (ISO 14050:2009) |
| 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 |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| IEC 61032:1997 | Protection of persons and equipment by enclosures - Probes for verification |
| 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 60770-1:2011 | Transmitters for use in industrial-process control systems - Part 1: Methods for performance evaluation |
| ISO 228-1:2000 | Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation |
| EN ISO 14738:2008 | Safety of machinery - Anthropometric requirements for the design of workstations at machinery (ISO 14738:2002, including Cor 1:2003 and Cor 2:2005) |
| EN 13060:2014 | Small steam sterilizers |
| ISO 14050:2009 | Environmental management Vocabulary |
| 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 60204-1 : 2006 COR 2010 | SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS |
| IEC 60770-1:2010 | Transmitters for use in industrial-process control systems - Part 1: Methods for performance evaluation |
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