13/30278676 DC : 0
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
Available format(s)
Hardcopy , PDF
Superseded date
31-01-2016
Superseded by
Language(s)
English
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Mechanical components
5 Process components
6 Instrumentation, indicating and recording devices
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 local environment
14 Testing
15 Hollow load test
16 Thermometric te
17 Bowie and Dick test
18 Air leakage test
19 Air detector tests
20 Load dryness test
21 Steam quality test
22 Dynamic sterilizer chamber pressure test
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) - Steam supply: suggested maximum
values of contaminants in feed water and condensate
Annex C (informative) - Temperature and time tolerances
during the small load thermometric test
Annex D (informative) - Guidance for installation and
operational qualification tests to 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) - Test procedures
Annex G (informative) - Assessing hazards caused by door
movement
Annex H (normative) - Additional requirements according to
machinery function
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography
BS EN 285.
| Committee |
LBI/35
|
| DocumentType |
Draft
|
| Pages |
103
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 285 : DRAFT 2013 | 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 |
| CEN Guide 414:2017 | Safety of machinery - Rules for the drafting and presentation of safety standards |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| ISO 4871:1996 | Acoustics — Declaration and verification of noise emission values of machinery and equipment |
| 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 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) |
| EN 60584-2:1993 | Thermocouples - Part 2: Tolerances |
| 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 |
| EN 764-1:2015+A1:2016 | Pressure equipment - Part 1: Vocabulary |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 |
| IEC 61508-4:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508) |
| 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) |
| 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/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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 |
| 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 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 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| 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) |
| EN ISO 13849-2:2012 | Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012) |
| EN 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| EN ISO 4871:2009 | Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996) |
| EN ISO 14050:2010 | Environmental management - Vocabulary (ISO 14050:2009) |
| EN 14222:2003 | Stainless steel shell boilers |
| EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| 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 ISO 10012:2003 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
| 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 |
| ISO 228-1:2000 | Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation |
| EN 13060:2014 | Small steam sterilizers |
| ISO 14050:2009 | Environmental management Vocabulary |
| 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 |
| 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 |
| EN 61508-4:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations |
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