ISO 18190:2016
Anaesthetic and respiratory equipment — General requirements for airways and related equipment
ISO 18190:2016 specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it.
The requirements of a device-specific standard take priority over ISO 18190:2016.
NOTE General requirements contained in ISO 18190:2016 have historically been referenced in more than two other airways and related equipment standards.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$240.87 NZD
|
|
| HardCopy |
$277.39 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for airways and related equipment
4.1 * Risk management
4.2 Usability
4.3 Clinical evaluation
4.4 Biophysical or modelling research
5 Materials
5.1 Biological safety testing
5.2 Intended use and environmental conditions
5.3 Leaching
5.4 Cleaning, disinfecting or sterilizing agents
5.5 Phthalates
5.6 Natural rubber (latex)
5.7 Gas compatibility
5.8 * Durability of marking
5.9 Resistance to deterioration
5.10 Magnetic resonance imaging (MRI) compatibility
6 Design requirements for airways and related equipment
6.1 Mechanical safety
6.2 Medical electrical equipment safety
6.3 Pneumatic safety
6.4 Protection against inadvertent adjustments
6.5 * Prevention of electrostatic charges
6.6 Device lifetime
7 Requirements for airways and related equipment supplied sterile
7.1 Sterility assurance
8 Packaging
9 Information supplied by the manufacturer
9.1 Marking
9.1.1 General
9.1.2 Marking on controls and instruments
9.2 Instructions for use
Annex A (informative) Rationale
Annex B (informative) Hazard identification for risk assessment
Bibliography
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS 3200.2.4:2006
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators
-
AS/NZS IEC 60601.2.20:2022 (RLV)
Medical electrical equipment, Part 2.20: Particular requirements for the basic safety and essential performance of infant transport incubators
-
AS/NZS IEC 60601.2.21:2015
Medical electrical equipment - Part 2.21: Particular requirements for the basic safety and essential performance of infant radiant warmers -
BS 341-2:1963
Transportable gas container valves, Valves with taper stems for use with breathing apparatus
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for airways and related equipment
4.1 * Risk management
4.2 Usability
4.3 Clinical evaluation
4.4 Biophysical or modelling research
5 Materials
5.1 Biological safety testing
5.2 Intended use and environmental conditions
5.3 Leaching
5.4 Cleaning, disinfecting or sterilizing agents
5.5 Phthalates
5.6 Natural rubber (latex)
5.7 Gas compatibility
5.8 * Durability of marking
5.9 Resistance to deterioration
5.10 Magnetic resonance imaging (MRI) compatibility
6 Design requirements for airways and related equipment
6.1 Mechanical safety
6.2 Medical electrical equipment safety
6.3 Pneumatic safety
6.4 Protection against inadvertent adjustments
6.5 * Prevention of electrostatic charges
6.6 Device lifetime
7 Requirements for airways and related equipment supplied sterile
7.1 Sterility assurance
8 Packaging
9 Information supplied by the manufacturer
9.1 Marking
9.1.1 General
9.1.2 Marking on controls and instruments
9.2 Instructions for use
Annex A (informative) Rationale
Annex B (informative) Hazard identification for risk assessment
Bibliography