Source: https://infostore.saiglobal.com/en-au/standards/pren-17180-draft-2017-343067_saig_cen_cen_785447/
Timestamp: 2020-08-09 12:01:02
Document Index: 42114903

Matched Legal Cases: ['ART 2', 'ART 1', 'ART 1', 'ART 1', 'ART 2', 'ART 1', 'ART 17', 'ART 1', 'ART 1', 'ART 1', 'ART 1', 'ART 5', 'ART 1', 'ART 2', 'ART 1', 'ART 9']

PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING | SAI Global
PREN 17180 : DRAFT 2017
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
4 Mechanical components and assemblies
5 Instrumentation, indicating and recording devices
7 Performance requirements
8 Safety, Risk control and usability
9 Packaging, marking and labelling
10 Information to be supplied by the manufacturer
11 Services and local environment
Annex A (informative) - Sterilizer classification and test
Annex B (normative) - Test equipment
Annex C (normative) - Test loads
Annex D (normative) - Test procedures
Annex E (informative) - Measurement of hydrogen peroxide
Annex F (informative) - H2O2 residues on medical devices
Annex G (normative) - Protective measures
Annex H (informative) - Environmental aspects
Directive 93/42/EEC [OJ L 169] aimed to be
Gives requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
NEN EN 17180 : DRAFT 2018 Identical
DIN EN 17180 : DRAFT 2017 Identical
17/30364306 DC : DRAFT DEC 2017 Identical
IEC 61010-2-040 : 2.0 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
2006/42/EC : 2006 AMD 4 2014 DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 17 MAY 2006 ON MACHINERY, AND AMENDING DIRECTIVE 95/16/EC (RECAST) (TEXT WITH EEA RELEVANCE)
EN 61326-1 : 2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 1: GENERAL REQUIREMENTS (IEC 61326-1:2012)
ISO 11138-1 : 2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
EN ISO 3740 : 2000 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES - GUIDELINES FOR THE USE OF BASIC STANDARDS
ISO 534 : 2011(R2017) PAPER AND BOARD - DETERMINATION OF THICKNESS, DENSITY AND SPECIFIC VOLUME
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
ISO 8787 : 1986(R2018) PAPER AND BOARD - DETERMINATION OF CAPILLARY RISE - KLEMM METHOD
EN ISO 11140-1 : 2014 COR 2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
EN ISO 13849-2 : 2012 SAFETY OF MACHINERY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 2: VALIDATION (ISO 13849-2:2012)
EN 1717 : 2000 PROTECTION AGAINST POLLUTION OF POTABLE WATER IN WATER INSTALLATIONS AND GENERAL REQUIREMENTS OF DEVICES TO PREVENT POLLUTION BY BACKFLOW
EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
EN ISO 4017 : 2014 FASTENERS - HEXAGON HEAD SCREWS - PRODUCT GRADES A AND B (ISO 4017:2014)
EN ISO 11138-1 : 2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
ISO 3781 : 2011(R2017) PAPER AND BOARD - DETERMINATION OF TENSILE STRENGTH AFTER IMMERSION IN WATER
EN ISO 10993-17 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
IEC 61326-1 : ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 1: GENERAL REQUIREMENTS
IEC 60584-1 : 3.0 THERMOCOUPLES - PART 1: EMF SPECIFICATIONS AND TOLERANCES
EN 1041 : 2008 + A1 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
EN 1837 : 1999 + A1 2009 SAFETY OF MACHINERY - INTEGRAL LIGHTING OF MACHINES
EN ISO 534 : 2011 PAPER AND BOARD - DETERMINATION OF THICKNESS, DENSITY AND SPECIFIC VOLUME (ISO 534:2011)
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
EN ISO 15223-1 : 2016 COR 2017 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
EN 14222 : 2003 STAINLESS STEEL SHELL BOILERS
ISO 4017 : 2014 FASTENERS - HEXAGON HEAD SCREWS - PRODUCT GRADES A AND B
EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
93/42/EEC : 1993 AMD 5 2007 COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
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 2758 : 2014 PAPER - DETERMINATION OF BURSTING STRENGTH
ISO 11140-1 : 2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ISO 11607-2 : 2006(R 2015) PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
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
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
ISO 2861 : 2013 VACUUM TECHNOLOGY - DIMENSIONS OF CLAMPED-TYPE QUICK-RELEASE COUPLINGS
ISO 1762 : 2015 PAPER, BOARD AND PULPS - DETERMINATION OF RESIDUE (ASH) ON IGNITION AT 525 DEGREE C
EN 1422 : 2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
EN 868-9 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ISO 536 : 2012(R2018) PAPER AND BOARD - DETERMINATION OF GRAMMAGE
EN 62304 : 2006 AMD 1 2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
EN ISO 536 : 2012 PAPER AND BOARD - DETERMINATION OF GRAMMAGE (ISO 536:2012)