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YY/T 1778.1-2021Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (English PDF)

医疗应用中呼吸气体通路生物相容性评价第1部分：风险管理过程中的评价与试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 1778.1-2021 is the English-translated version of 医疗应用中呼吸气体通路生物相容性评价第1部分：风险管理过程中的评价与试验.

YY/T 1778.1-2021 is the Chinese standard "Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process".

Its scope clause reads: This section specifies the general principles to be followed when evaluating the biocompatibility of medical device materials that make up the gas pathway, including. --- In the process of risk management, medical devices intended to be used in various environments to supply gas or other substances to patients through the respiratory tract Basic principles to be followed in the biological risk assessment of gas access products on equipment, its components or accessories; --- General classification of gas passages according to the nature and duration of contact with the gas flow; --- evaluation of existing data from all sources; --- identification of defects in available data sets based on risk analysis; --- Identification of other data sets required for gas pathway biosafety analysis; --- Assessment of the biological safety of the gas pathway.

This section does not specify. --- how to assess the biological hazard (source) caused by a mechanical failure, unless the failure poses a risk of toxicity (for example, by particles). --- How to detect specific tests for potentially harmful substances entering the inhalable airflow, and develop acceptance criteria for these substances.

Note 1.See other parts of YY/T 1778 (ISO 18562) for specific tests for the detection of potentially harmful substances entering the inhalable airflow. ---How to carry out biological evaluation of the surfaces of medical devices in direct contact with patients.

Note 2.See GB/T 16886 series for the evaluation requirements for direct contact with the surface of medical devices.

This section applies to medical devices, components or accessories containing gas passages, including but not limited to. ventilators, anesthesia workstations (including gas body mixer), breathing systems, oxygen storage devices, oxygen concentrators, nebulizers, low pressure hose assemblies, humidifiers, heat and moisture exchangers, breathing gas body monitors, respiratory monitors, masks, oral devices, resuscitators, breathing circuits, respiratory filters and Y-tubes and are expected to be All breathing accessories used with these medical devices.

This section also applies to the closed chamber of the incubator, including the mattress and the inner surface of the oxygen mask. Note 3.This section deals with medical devices throughout their expected service life under normal use, and takes into account the effects of all processing or reprocessing.

Note 4.This section deals with the potential contamination of the gas flow in the medical device gas path that may lead to the patient. Note 5.This section does not involve contamination that already exists in the gas from the gas source during normal use of the medical device.

Note 6.YY/T 1778 (ISO 18562) (all parts) does not involve contamination of the medical gas pipeline system (including the check valve at the pipeline outlet) of medical devices, Contamination of the outlet of the pressure regulator connected or integrated with the medical gas cylinder, or air source pollution such as indoor air entering the medical device.

Note 7.In the future, more sections may be added to conduct biological tests on other relevant aspects, including due to the addition of drugs and anesthetics to the airflow Other contamination issues that can be caused by the gas path.

Note 8.The preparation of this section is to guide the evaluation of compliance with the basic principles of safety and performance shown in Appendix B.

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Document preview — YY/T 1778.1-2021

National Standard of the People's Republic of China

Classification: C 46

Issued by: National Medical Products Administration of the People's Republic of China

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Basic principles of biocompatibility evaluation of medical devices
4.1 Overview
4.2 Type test
4.3 Biocompatibility Hazard (Source) Identification
4.4 Scope of risk assessment
4.5 Biocompatibility Evaluation Plan
4.6 Trial selection
4.7 Follow-up evaluation
5 Contamination of breathing gas in the gas path
5.1 * Continuous use time
5.2 Particulate Matter (PM) Emissions
5.3 Volatile Organic Compound (VOC) Emissions
5.4 Leachables in condensate
6 Adjust for different patient groups
6.1 General considerations
6.2 Adjustment for body weight
6.3 *The allowable concentration is derived from the tolerable exposure level
7 * Derivation allows limit of
7.1 General Process
7.2 Medical devices for short-term exposure (<=24h)
7.3 Medical devices for long-term exposure (>24h but < 30d)
7.4 Medical devices for permanent contact (>=30d)
8 Risk Benefit Analysis
9 Assessment of Biocompatibility of Medical Devices
Appendix A (Informative Appendix) Principles and Guidelines
Appendix B (Informative Appendix) Basic Numbering Principle
Appendix C (Informative Appendix) Terminology --- Alphabetical index of terms used in the text

1 Scope

This section specifies the general principles to be followed when evaluating the biocompatibility of medical device materials that make up the gas pathway, including.

--- In the process of risk management, medical devices intended to be used in various environments to supply gas or other substances to patients through the respiratory tract

Basic principles to be followed in the biological risk assessment of gas access products on equipment, its components or accessories;

--- General classification of gas passages according to the nature and duration of contact with the gas flow;

--- evaluation of existing data from all sources;

--- identification of defects in available data sets based on risk analysis;

--- Identification of other data sets required for gas pathway biosafety analysis;

--- Assessment of the biological safety of the gas pathway.

This section does not specify.

--- how to assess the biological hazard (source) caused by a mechanical failure, unless the failure poses a risk of toxicity (for example, by particles).

--- How to detect specific tests for potentially harmful substances entering the inhalable airflow, and develop acceptance criteria for these substances.

Note 1.See other parts of YY/T 1778 (ISO 18562) for specific tests for the detection of potentially harmful substances entering the inhalable airflow.

---How to carry out biological evaluation of the surfaces of medical devices in direct contact with patients.

Note 2.See GB/T 16886 series for the evaluation requirements for direct contact with the surface of medical devices.

All breathing accessories used with these medical devices.

This section also applies to the closed chamber of the incubator, including the mattress and the inner surface of the oxygen mask.

Note 3.This section deals with medical devices throughout their expected service life under normal use, and takes into account the effects of all processing or reprocessing.

Note 4.This section deals with the potential contamination of the gas flow in the medical device gas path that may lead to the patient.

Note 5.This section does not involve contamination that already exists in the gas from the gas source during normal use of the medical device.

Note 6.YY/T 1778 (ISO 18562) (all parts) does not involve contamination of the medical gas pipeline system (including the check valve at the pipeline outlet) of medical devices,

Contamination of the outlet of the pressure regulator connected or integrated with the medical gas cylinder, or air source pollution such as indoor air entering the medical device.

Note 7.In the future, more sections may be added to conduct biological tests on other relevant aspects, including due to the addition of drugs and anesthetics to the airflow

Other contamination issues that can be caused by the gas path.

Note 8.The preparation of this section is to guide the evaluation of compliance with the basic principles of safety and performance shown in Appendix B.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process (ISO 10993-1.2009, IDT)

GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17.Establishment of allowable limits for leachables (ISO 10993-

17.2002, IDT) […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 16886.18-2022|YY/T 0916.7-2024|YY/T 1842.7-2023|YY/T 0916.3-2022|YY/T 0916.6-2022|YY/T 1842.1-2022

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