02/121895 DC : DRAFT APR 2002

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Foreword Introduction 1 Scope 2 Normative references 3 Definitions 4 General technical requirements 5 Performance requirements 6 Safety 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 3.19 and 3.20) 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) Examples of temperature profiles during          the holding time Annex G (informative) Rationale for the tests Annex ZA (informative) Clauses of this European Standard          addressing essential requirements or other          provisions of EU Directives Bibliography

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BS EN 13060

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Published
Document Type	Draft
Status	Superseded
Publisher	British Standards Institution
Pages
ISBN
Committee	LBI/35/8
Superseded By	BS EN 13060 : 2014
Comment Closes On

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
PREN 13060 : DRAFT 2012	Identical

Standards Referencing This Book - (Show below) - (Hide below)

EN 50081-1 : 1992	ELECTROMAGNETIC COMPATIBILITY - GENERIC EMISSION STANDARD - RESIDENTIAL, COMMERCIAL AND LIGHT INDUSTRY
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
EN 556-1 : 2001 COR 2006	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
EN 60584-2 : 1993	THERMOCOUPLES - PART 2: TOLERANCES (IEC 584-2:1982 + A1:1989)
EN 285 : 2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
IEC 60073 : 6.0	BASIC AND SAFETY PRINCIPLES FOR MAN-MACHINE INTERFACE, MARKING AND IDENTIFICATION - CODING PRINCIPLES FOR INDICATORS AND ACTUATORS
EN 61010-2-041 : 96 COR 1996	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PARTICULAR REQUIREMENTS FOR AUTOCLAVES USING STEAM FOR THE TREATMENT OF MEDICAL MATERIALS AND FOR LABORATORY PROCESSES
EN 60073 : 2002	BASIC AND SAFETY PRINCIPLES FOR MAN-MACHINE INTERFACE, MARKING AND IDENTIFICATION - CODING PRINCIPLES FOR INDICATORS AND ACTUATORS
EN 46001 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 475 : 1995	MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS
ISO 14937 : 2009(R2015)	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
EN 61326 : 97 AMD 3 2003
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 OF TYPE B AND TYPE S
ISO 3746 : 2010(R2015)	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 764 : 1994	PRESSURE EQUIPMENT - TERMINOLOGY AND SYMBOLS - PRESSURE, TEMPERATURE, VOLUME
EN 866-1 : 1997	BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
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
EN 60751 : 2008	INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
EN 61000-6-2 : 2005 COR 2005	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY FOR INDUSTRIAL ENVIRONMENTS (IEC 61000-6-2:2005)
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE)
93/42/EEC : 1993 AMD 5 2007	COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
IEC 61010-2-041 : 1.0	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PARTICULAR REQUIREMENTS FOR AUTOCLAVES USING STEAM FOR THE TREATMENT OF MEDICAL MATERIALS, AND FOR LABORATORY PROCESSES
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
IEC 60751 : 2.0	INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
EN 867-1 : 1997	NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS
EN 61010-1 : 2010	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS (IEC 61010-1:2010)
EN 60529 : 1991 COR 2016	DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
EN 866-3 : 1997	BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
IEC 61010-1 : 3.1	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
IEC 61326 : 2.0
IEC 61000-6-2 : 3.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS
EN ISO 10993-1 : 2009 COR 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO 228-1 : 2000(R2016)	PIPE THREADS WHERE PRESSURE-TIGHT JOINTS ARE NOT MADE ON THE THREADS - PART 1: DIMENSIONS, TOLERANCES AND DESIGNATION
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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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