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BS EN 285:2015

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Sterilization. Steam sterilizers. Large sterilizers
Available format(s)

Hardcopy , PDF

Withdrawn date

12-01-2021

Language(s)

English

Published date

01-31-2016

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Mechanical components
5 Piping system and components
6 Measuring system, indicating and recording devices
   for temperature, pressure, time and status indicators
7 Control systems
8 Performance requirements
9 Sound power and vibration
10 Rate of pressure change
11 Safety, risk control and usability
12 Packaging and marking
13 Service and working environment
14 Testing
15 Hollow load test
16 Thermometric tests
17 Bowie and Dick test
18 Air leakage test
19 Air detector tests
20 Load dryness test
21 Steam quality test
22 Rate of pressure change
23 Test apparatus, equipment and material
24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer
Annex A (informative) - Environmental aspects
Annex B (informative) - Suggested maximum values of
        contaminants in feed water
Annex C (informative) - Temperature and time tolerances
        during the small load thermometric test
Annex D (informative) - Guidance for installation and
        operational qualification tests which can be included
        in the instructions for use supplied with a sterilizer
Annex E (informative) - Criteria for identifying sterilizers as
        the same type
Annex F (normative) - Protective measures
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 the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules.

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.

Committee
CH/198
DevelopmentNote
Partially supersedes BS 3970-1(1990) Supersedes BS 3970-3(1990) and 92/58124 DC (03/2003) Supersedes 02/124462 DC. (06/2006) Supersedes 06/30153419 DC. (06/2008) Supersedes 13/30278676 DC. (01/2016)
DocumentType
Standard
Pages
106
PublisherName
British Standards Institution
Status
Withdrawn
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
DIN EN 285:2016-05 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

CSA Z314.3 : 2009 : R2014 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
BS EN 867-3:1997 Non-biological systems for use in sterilizers Specification for Class B indicators for use in the Bowie and Dick test
CSA Z314.3 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
BS 6850:2002 Gas powered ventilatory resuscitators
BS EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes Particular systems for use in moist heat sterilizers

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
EN 764-7:2002/AC:2006 PRESSURE EQUIPMENT - PART 7: SAFETY SYSTEMS FOR UNFIRED PRESSURE EQUIPMENT
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 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
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 ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
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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