DIN EN ISO 80601-2-72:2016-04

Superseded

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)

Available format(s)

Hardcopy , PDF

Superseded date

12-01-2023

Language(s)

German, English

Published date

04-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN ISO 10651-2. DIN EN ISO 10651-2 issue 06-2011 remains valid alongside this standard until 30-09-2018. Applies in conjunction with DIN EN 60601-1 issue 12-2013. (05/2016)
DocumentType	Standard
Pages	105
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 80601-2-72:2023-12
Supersedes	DIN EN ISO 10651-2:2011-06

Standards	Relationship
ISO 80601-2-72:2015	Identical
EN ISO 80601-2-72:2015	Identical

VDE 0750-1-3 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013)
DIN ISO 7000:2008-12	Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV	Information technology equipment - Safety - Part 1: General requirements
IEC 60038:2009	IEC standard voltages
ISO 8836:2014	Suction catheters for use in the respiratory tract
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
ISO 4871:1996	Acoustics — Declaration and verification of noise emission values of machinery and equipment
DIN EN ISO 15223-1:2015-08 (Draft)	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)
ISO 3744:2010	Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
ISO 80601-2-13:2011	Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
DIN EN ISO 7396-1:2016-09	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
DIN EN 61672-1:2014-07	ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN 13718-1:2014	Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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
DIN EN ISO 10651-4:2009-08	Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
DIN EN ISO 10651-6:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 5359:2015-02	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
ISO 10651-6:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
DIN EN 60601-1-3 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013)
DIN EN 60601-2-2 : 2010	MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
CFR 45(PTS1-199) : OCT 2017	PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
DIN EN 60601-1-6 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013)
VDE 0750-1-2 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
DIN EN ISO 17664:2016-06 (Draft)	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
VDE 0750-2-2 : 2010	MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
DIN EN 62366 : 2016	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
IEC 60721-3-7:1995+AMD1:1996 CSV	Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 10651-4:2002	Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
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
VDE 0750-101 : 2016	MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
VDE 0750-1-6 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013)
DIN EN ISO 3744:2011-02	Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 5356-2:2012	Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
DIN EN 60721-3-7:1995-09	CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE
ISO 32:1977	Gas cylinders for medical use — Marking for identification of content
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
ISO 5359:2014	Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
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
VDE 0750-241 : 2016	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
IEC 62304:2006+AMD1:2015 CSV	Medical device software - Software life cycle processes
ISO 14159:2002	Safety of machinery — Hygiene requirements for the design of machinery
ISO 23328-2:2002	Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
DIN EN ISO 5356-1:2015-06	ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015)
DIN EN ISO 80369-2:2015-09 (Draft)	SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS (ISO/DIS 80369-2:2015)
ASTM F 2761 : 2009 : R2013	Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
DIN EN ISO 80601-2-55 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2011)
DIN EN 20594-1:1995-01	CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
IEC 60601-1-3:2008+AMD1:2013 CSV	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 80601-2-55:2011	Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 17510:2015	Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 23328-1:2003	Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
DIN EN ISO 5356-2:2013-03	ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
DIN EN 62304 : 2016	MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
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
EN 1789:2007+A2:2014	Medical vehicles and their equipment - Road ambulances
DIN EN ISO 10524-1:2006-05	PRESSURE REGULATORS FOR USE WITH MEDICAL GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
DIN EN ISO 14159:2008-07	SAFETY OF MACHINERY - HYGIENE REQUIREMENTS FOR THE DESIGN OF MACHINERY
DIN EN ISO 5367:2015-02	Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
DIN EN ISO 80369-1:2015-09 (Draft)	SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
ISO 14971:2007	Medical devices Application of risk management to medical devices
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
DIN EN ISO 8836:2015-02	Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
DIN EN ISO 7010:2012-10	GRAPHISCHE SYMBOLE - SICHERHEITSFARBEN UND SICHERHEITSZEICHEN - REGISTRIERTE SICHERHEITSZEICHEN (ISO 7010:2011/AMD 5:2014)
ISO 10524-1:2006	Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 11195:1995	Gas mixers for medical use Stand-alone gas mixers
VDE 0750-1 : 2013	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
VDE 0750-1-11 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
VDE 0750-2-55 : 2012	MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-55: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON UEBERWACHUNGSGERAETEN FUER ATEMGASE (ISO 80601-2-55:2011)
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
VDE 0750-2-12 : 2012	MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-12: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON BEATMUNGSGERAETEN FUER DIE INTENSIVPFLEGE (ISO/IEC 80601-2-12:2011 + COR.:2011)
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
DIN EN ISO 4135:2002-03	Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
DIN EN 60601-1-11 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
ISO 7396-1:2016	Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum