02/121895 DC : DRAFT APR 2002

Name: 02/121895 DC : DRAFT APR 2002
Brand: BSI

Superseded

View Superseded by

BS EN 13060 - SMALL STEAM STERILIZERS

Superseded date

08-03-2005

Published date

11-23-2012

Publisher

British Standards Institution

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

BS EN 13060

Committee	LBI/35/8
DocumentType	Draft
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 13060 : 2014

Standards	Relationship
PREN 13060 : DRAFT 2012	Identical

EN 50081-1:1992	Electromagnetic compatibility - Generic emission standard - Part 1: 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 (ISO 14937:2009)
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
EN 61010-2-041:1996/corrigendum: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	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 61326:1997/A3:2003
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 Type B and Type S
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 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 (ISO 3746:2010)
EN 60751:2008	INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
EN 61000-6-2:2005/corrigendum: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)
IEC 61010-2-041:1995	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: 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 60751:2008	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
EN 60529:1991/AC:2016-12	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 61010-1:2010+AMD1:2016 CSV	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61000-6-2 : 3.0:2016	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS
EN ISO 10993-1:2009/AC: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	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