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BS EN ISO 10651-5:2021

BS EN ISO 10651-5:2021

$198.66

Lung ventilators for medical use. Particular requirements for basic safety and essential performance – Gas-powered emergency resuscitators

Published By Publication Date Number of Pages
BSI 2021 54
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This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) 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.

This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22).

This part of ISO 10651 is not applicable to electrically-powered resuscitators.

NOTE ISO 10651‑3covers emergency and transport ventilators.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 * Scope
2 Normative references
10 3 Terms and definitions
12 4 General requirements
4.1 General
13 4.2 Other test methods
4.3 Acceptance criteria
5 Constructional requirements
5.1 General
5.1.1 Materials of construction
14 5.1.2 Surfaces, corners and edges
5.1.3 Leaching of substances
5.1.4 Breathing tubes
5.1.5 Supply of sterile components
5.1.6 * Breathing system filter
5.1.7 Arrangement of functions
5.1.8 Protection against accidental adjustments
15 5.1.9 Selector switches/controls
5.1.10 Accuracy of operating data
5.1.11 * Resuscitator set
5.2 Connectors
5.2.1 Connection to the medical gas supply system
5.2.2 Connection to the high-pressure gas input port
16 5.2.3 Patient connection port connector
5.2.4 Facemask connector
5.2.5 * Gas exhaust port connector
5.2.6 Resuscitator inspiratory limb connectors
5.2.7 Emergency air intake port
6 Operational requirements
6.1 General
6.1.1 * Patient valve function after contamination with vomitus
17 6.1.2 Cleaning, and sterilization or disinfection
6.1.3 * Functional test after reassembly
6.1.4 Flow-direction-sensitive component connectors
6.2 Resistance to environmental influences
6.2.1 * Storage and operating conditions
18 6.3 Resistance to typical use
6.3.1 Mechanical shock
6.3.2 Splash proof
6.3.3 * Immersion in water
6.4 Size and mass
6.4.1 * Size
6.4.2 * Mass
19 6.5 Gas supply
6.5.1 Gas cylinders and cylinder valve
6.5.2 Captive cylinder valve key
6.5.3 Cylinder regulator
6.5.4 External supply
6.5.5 Permanently connected resuscitator
6.5.6 * Intermediate hose
20 6.5.7 Gas container capacity
7 Performance
7.1 Ventilatory requirements
7.1.1 * Delivered oxygen concentration
7.1.2 * Resistance to spontaneous breathing
21 7.1.3 * Inadvertent PEEP
7.1.4 * Inadvertent continuing expiratory pressure
7.1.5 * Resuscitator dead space and dead space of airway accessories
7.2 * Ventilation performance
7.2.1 General
22 7.2.2 * Delivered volume (Vdel)
7.2.3 * Consistency of delivered volume
23 7.2.4 Pressure limitation under normal use
7.2.5 Pressure limitations under single fault condition
7.2.6 * Pressure-limitation activation alarm signal
7.2.7 * Inspiratory flow
7.2.8 Operation of manual trigger on a manually-cycled resuscitator
7.2.9 Demand valve
24 7.2.10 * Patient-triggered resuscitator
8 Identification, marking and documents
8.1 General
8.1.1 Conditions
8.1.2 Units of measure
25 8.2 Marking
8.2.1 * Legibility of markings
8.2.2 * Durability of markings
8.2.3 Identification
8.2.4 Controls and indicators
26 8.2.5 Indication of pressure-limiting device setting
8.2.6 Indication of use of function affecting performance
8.2.7 Indication of pneumatic power rating
8.2.8 Flow-direction-sensitive component
8.2.9 Indication of latex
8.2.10 Indication of protection against water ingress
8.3 Information provided by the manufacturer for operation and maintenance
8.3.1 General
27 8.3.2 Contents
30 Annex A (informative) Rationale
36 Annex B (normative) Test methods
48 Annex C (informative) Relationship between this part of ISO 10651 and cardiopulmonary resuscitation guidelines
49 Annex D (informative) Clauses of this part of ISO 10651 addressing the essential principles
51 Annex E (informative) Terminology — Index of defined terms
53 Bibliography

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BS EN ISO 10651-5:2021
$198.66