Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

Published date

06-28-2006

Publisher

European Committee for Standards - Electrical

Specifies the safety requirements for ventilators, as defined below, intended for use in critical care settings. Ventilator: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient.

Committee	CLC/TC 62
DocumentType	Standard
PublisherName	European Committee for Standards - Electrical
Status	Current

Standards	Relationship
NBN EN 60601-2-12 : 2007	Identical
CEI EN 60601-2-12 : 2007	Identical
UNE-EN 60601-2-12:2007	Identical
BS EN 60601-2-12:2006	Identical
VDE 0750-2-12 : 2012	Identical
I.S. EN 60601-2-12:2006	Identical
DIN EN 60601-2-12 : 2007	Identical
PN EN 60601-2-12 : 2006	Identical
NEN EN IEC 60601-2-12 : 2006	Identical
IEC 60601-2-12:2001	Identical
SN EN 60601-2-12 : 2006	Identical
NF EN 60601-2-12 : 2007	Identical

12/30266576 DC : 0	BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
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UNE-EN 13718-2:2015	Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13718-2:2015	Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
I.S. EN 13718-2:2015	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
I.S. EN 13718-2:2015+A1:2020	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 8835-3:2007	Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
ISO 11138-3:2017	Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 9703-1:1992	Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
IEC 60416:1988	General principles for the formulation of graphical symbols
IEC 60417-1:2002	Graphical symbols for use on equipment - Part 1: Overview and application
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10651-2:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 7767:1997	Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
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ISO 9703-3:1998	Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms
NFPA 53 : 2016	MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
EN 60601-1-1:2001	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 9918:1993	Capnometers for use with humans Requirements
ISO 5356-2:2012	Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 11138-2:2017	Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 5367:2014	Anaesthetic and respiratory equipment — Breathing sets and connectors
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 5359:2014	Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
ISO 5362:2006	Anaesthetic reservoir bags
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 10651-3:1997	Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
ISO 8185:2007	Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 7396:1987	Non-flammable medical gas pipeline systems
IEC 60601-2-13:2003+AMD1:2006 CSV	Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
IEC 60417-2:1998	Graphical symbols for use on equipment - Part 2: Symbol originals
ISO 9919:2005	Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
IEEE DRAFT 1073 : D3.6 SEP 95	STANDARD FOR MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK
ISO 9360-1:2000	Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 60601-1-4:1996/A1:1999	MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
ISO 9360-2:2001	Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 11195:1995	Gas mixers for medical use Stand-alone gas mixers
IEC 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9703-2:1994	Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied