Valid

YY/T 1743-2021Anaesthetic and respiratory equipment—Nebulizing systems and components (English PDF)

麻醉和呼吸设备雾化系统和组件

Preview PDF

This is a limited preview

Buy now to download the full PDF (41 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1743-2021 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2021

Implementation date

May 1, 2023

Scope

YY/T 1743-2021 is the English-translated version of 麻醉和呼吸设备雾化系统和组件.

YY/T 1743-2021 is the Chinese standard "Anaesthetic and respiratory equipment—Nebulizing systems and components". Its scope clause reads: This standard specifies the general atomization system that is expected to deliver liquid to the human body in the form of a spray continuously or triggered by breathing through the respiratory system.

Safety and performance testing requirements. This standard applies to pneumatic atomization equipment, which can be powered by compressors, piping systems, cylinders, etc., as well as electric atomization equipment (such as rotary Turntable, ultrasonic, vibrating screen (active and passive), and capillary device] or manual atomization equipment.

This standard does not specify the minimum performance of the atomization system. This standard does not apply to nasal washing equipment. This standard does not apply to equipment intended to provide moisture or hydration only by providing water in the form of aerosol particles.

Note. Refer to ISO 8185[3] for such equipment. This standard does not apply to specific drug delivery nebulization devices or their components (e.g. metered-dose inhalers, metered-dose liquid inhalers, dry powder inhalers).

Found what you need?

Document preview — YY/T 1743-2021

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

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and test requirements
4.1 Risk Management
4.2 Test methods and alternative methods
4.3 Electrical safety
4.4 Safety of machinery
4.5 Pneumatic safety
4.6 Prevent unconscious adjustment
4.7 Availability
5 Sign
5.1 Symbol
5.2 Marking on the device
5.3 Labels on packaging or individual packaging
5.4 Instructions for use, inserts and accompanying documents
6 Structural requirements
6.1 Material
6.2 Connector
6.3 Control knob
7 Cleaning, sterilization and disinfection
8 Biocompatibility
Appendix A (Informative Appendix) Basic Principles
Appendix B (Normative Appendix) Diameter of Respirable Fractional Particles
Appendix C (Normative Appendix) Test methods for aerosol particle output and spray rate
Appendix D (Normative Appendix) Test Method for Particle Diameter
Appendix E (informative appendix) Hazard identification in risk assessment
Appendix F (informative appendix) Classification of general atomization equipment
Appendix G (informative appendix) Environmental aspects
Appendix AA (informative appendix) Reference to basic principles

1 Scope

This standard specifies the general atomization system that is expected to deliver liquid to the human body in the form of a spray continuously or triggered by breathing through the respiratory system.

Safety and performance testing requirements.

This standard applies to pneumatic atomization equipment, which can be powered by compressors, piping systems, cylinders, etc., as well as electric atomization equipment (such as rotary

Turntable, ultrasonic, vibrating screen (active and passive), and capillary device] or manual atomization equipment.

This standard does not specify the minimum performance of the atomization system.

This standard does not apply to nasal washing equipment.

This standard does not apply to equipment intended to provide moisture or hydration only by providing water in the form of aerosol particles.

Note. Refer to ISO 8185[3] for such equipment.

This standard does not apply to specific drug delivery nebulization devices or their components (e.g. metered-dose inhalers, metered-dose liquid inhalers, dry powder inhalers)

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1.

2012, MOD)

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1-

2011, ISO 10993-1.2009, IDT)

GB 18278.1 Sterilization of Medical and Health Products Moisture Heat Part 1.Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices

Seek (GB 18278.1-2015, ISO 17665-1.2006, IDT)

GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and routine control of the sterilization process of medical devices

System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT)

GB 18280.1 Sterilization radiation of medical and health care products Part 1.Development, validation and routine control requirements for the sterilization process of medical devices

Seek (GB 18280.1-2015, ISO 11137-1..2006, IDT)

GB 18280.2 Medical and health care products sterilization radiation Part 2.Establishment of sterilization dose (GB 18280.2-2015, ISO 11137-2.

2006, IDT)

GB/T 18280.3 Medical and health care products sterilization radiation Part 3.Dose measurement guidelines (GB/T 18280.3-2015,

ISO 11137-3.2006, IDT)

GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT)

GB 50751 Technical Specification for Medical Gas Engineering

YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction

Version, IDT)

YY 0461 Breathing circuit for anesthesia machine and ventilator (YY 0461-2003, ISO 5367.2000, IDT)

YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 41 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 11137-3:2006

Similar standards

YY/T 1873-2023|YY/T 0735.2-2010|YY/T 0735.1-2009|YY/T 0753.1-2009|YY/T 0753.2-2009|YY 0499-2023

How to Download YY/T 1743-2021

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.