Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
Tuote ladattavissa hetiToimitusaika on noin 1 - 2 työpäivääToimitusaika on 3 - 5 työpäivää.
ISO 10651-5:2006 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use. ISO 10651-5:2006 also specifies the requirements for resuscitator sets. ISO 10651-5:2006 is not applicable to electrically-powered resuscitators.
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Sisällysluettelo
Foreword
Introduction
1 * Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Other test methods
4.3 Acceptance criteria
5 Constructional requirements
5.1 General
5.2 Connectors
6 Operational requirements
6.1 General
6.2 Resistance to environmental influences
6.3 Resistance to typical use
6.4 Size and mass
6.5 Gas supply
7 Performance
7.1 Ventilatory requirements
7.2 * Ventilation performance
8 Identification, marking and documents
8.1 General
8.2 Marking
8.3 Information provided by the manufacturer for operation and maintenance
Annex A Rationale (informative)
Annex B Test methods (normative)
Annex C Relationship between this part of ISO 10651 and cardiopulmonary resuscitation guidelines (informative)
Annex D Clauses of this part of ISO 10651 addressing the essential principles (informative)
Annex E Terminology — Index of defined terms (informative)
IEC 60529 Edition 2.1:2001
IEC 60601-1:1988 Medical electrical equipment - Part 1: General requirements for safety
ISO 1000:1992 SI units and recommendations for the use of their multiples and of certain other units
IEC 60529 Edition 2.1:2001
IEC 60601-1:1988 Medical electrical equipment - Part 1: General requirements for safety
ISO 1000:1992 SI units and recommendations for the use of their multiples and of certain other units
ISO 10297:2014 Gas cylinders — Cylinder valves — Specification and type testing
ISO 10524-1:2018 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 10524-3:2019 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs)
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 15223:2000 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
ISO 17664:2017 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
ISO 31-0:1992 Quantities and units — Part 0: General principles
ISO 31-0:1992/Amd 1:1998 Quantities and units — Part 0: General principles — Amendment 1
ISO 31-0:1992/Amd 2:2005 Quantities and units — Part 0: General principles — Amendment 2
ISO 31-1 AMD 1:1998 Quantities and units — Part 1: Space and time — Amendment 1
ISO 31-10:1992 Quantities and units — Part 10: Nuclear reactions and ionizing radiations
ISO 31-10:1992/Amd 1:1998 Quantities and units — Part 10: Nuclear reactions and ionizing radiations — Amendment 1
ISO 31-11:1992 Quantities and units — Part 11: Mathematical signs and symbols for use in the physical sciences and technology
ISO 31-12 AMD 1:1998 Quantities and units — Part 12: Characteristic numbers — Amendment 1
ISO 31-12:1992 Quantities and units — Part 12: Characteristic numbers
ISO 31-13 AMD 1:1998 Quantities and units — Part 13: Solid state physics — Amendment 1
ISO 31-13:1992 Quantities and units — Part 13: Solid state physics
ISO 31-1:1992 Quantities and units — Part 1: Space and time
ISO 31-2 AMD 1:1998 Quantities and units — Part 2: Periodic and related phenomena — Amendment 1
ISO 31-2:1992 Quantities and units — Part 2: Periodic and related phenomena
ISO 31-3 AMD 1:1998 Quantities and units — Part 3: Mechanics — Amendment 1
ISO 31-3:1992 Quantities and units — Part 3: Mechanics
ISO 31-4 AMD 1:1998 Quantities and units — Part 4: Heat — Amendment 1
ISO 31-4:1992 Quantities and units — Part 4: Heat
ISO 31-5 AMD 1:1998 Quantities and units — Part 5: Electricity and magnetism — Amendment 1
ISO 31-5:1992 Quantities and units — Part 5: Electricity and magnetism
ISO 31-6 AMD 1:1998 Quantities and units — Part 6: Light and related electromagnetic radiations — Amendment 1
ISO 31-6:1992 Quantities and units — Part 6: Light and related electromagnetic radiations
ISO 31-7 AMD 1:1998 Quantities and units — Part 7: Acoustics — Amendment 1
ISO 31-7:1992 Quantities and units — Part 7: Acoustics
ISO 31-8 AMD 1:1998 Quantities and units — Part 8: Physical chemistry and molecular physics — Amendment 1
ISO 31-8:1992 Quantities and units — Part 8: Physical chemistry and molecular physics
ISO 31-9:1992 Quantities and units — Part 9: Atomic and nuclear physics
ISO 31-9:1992/Amd 1:1998 Quantities and units — Part 9: Atomic and nuclear physics — Amendment 1
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
ISO 4135:2001 Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1:2015 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum