DIN EN ISO 80601-2-72 E : 2016
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2016
National foreword
National Annex NA (informative) Bibliography
European foreword
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
SYSTEMS
201.7 ME EQUIPMENT identification, marking and
documents
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of
ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
radiation HAZARDS
201.11 Protection against excessive temperatures and
other HAZARDS
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
201.101 Gas connections
201.102 Requirements for the VBS and ACCESSORIES
201.103 Spontaneous breathing during loss of power supply
201.104 Training
201.105 Indication of duration of operation
201.106 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATOR security
202 Electromagnetic disturbances - Requirements and
tests
206 Usability
208 General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical
electrical systems
211 Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment
Annex C (informative) - Guide to marking and labeling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Data interface requirements
Annex CC (informative) - Reference to the Essential Principles
Annex DD (informative) - Alphabetized index of defined terms
used in this particular standard
Annex ZA (informative) - Relationship between this Document
and the Essential Requirements of EU Directive 93/42/EEC
Bibliography
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended for use in the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; - intended for use with PATIENTS who are dependent on mechanical ventilation for their life support.
| DevelopmentNote |
Supersedes DIN EN ISO 10651-2 E. DIN EN ISO 10651-2 E 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 |
Current
|
| 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 EN ISO 8836 E : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| 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 |
| 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 61672-1:2014-07 | ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013) |
| DIN EN ISO 23328-2 E : 2009 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| 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 9360-2 E : 2009 | 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 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 ISO 5367 E : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| 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 |
| 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 |
| DIN EN ISO 9360-1 E : 2009 | 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 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 |
| DIN EN ISO 23328-1 E : 2008 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE |
| VDE 0750-101 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| 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 |
| DIN EN ISO 7010 E : 2012 | GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 6:2014) |
| 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 |
| 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) |
| 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 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 |
| 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 |
| 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 |
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