1Key Takeaways
This document specifies the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories which are intended to provide care or supply substances via the respiratory tract to a patient in all environments; the general categoriza…
2Scope / Description
This document specifies the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories which are intended to provide care or supply substances via the respiratory tract to a patient in all environments; the general categorization of gas pathways based on the nature and duration of their contact with the gas stream; the evaluation of existing relevant data from various sources necessary for risk analysis; the identification of gaps in the available dataset on the basis of this document; the assessment of the biological safety of the gas pathway.
5Citation Network
Standards that cite ISO 18562-1:2017
Referenced by ISO 18562-1:2017
BS 5724-3.12-1991
IEC 60601-1 AMD 1:2012
IEC 60601-1:2005
ISO 10993-13:2010
ISO 10993-14:2001
ISO 10993-15:2000
ISO 10993-17:2002
ISO 10993-1:2009
6Frequently Asked Questions
What is ISO 18562-1:2017?
ISO 18562-1:2017 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process is an international standard developed by International Organization for Standardization (ISO). This document specifies the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories which are intended to provide care or supply substances via the...
What does ISO 18562-1:2017 cover?
This standard covers: This document specifies the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories which are intended to provide care or supply substances via the respiratory tract to a patient in all environments;...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 18562-1:2017?
The current published version is ISO 18562-1:2017, published on 2017-03. Always check for amendments or pending revisions.
How do I purchase ISO 18562-1:2017?
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