YY/T 1665-2019Vibratory and pat sputum excretion machine (English PDF)
振动叩击排痰机
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 24, 2019
Implementation date
August 1, 2020
Scope
YY/T 1665-2019 is the English-translated version of 振动叩击排痰机.
YY/T 1665-2019 is the Chinese pharmaceutical industry standard for the vibratory percussion device used to help clear sputum, the machine whose motor drives a flexible shaft and an eccentric head that taps and vibrates part of the patient's chest.
It gives the classification, the composition, the requirements and the test methods, covering the frequency and the force of the percussion and their accuracy, the heads and their materials, the timer, the noise and the electrical safety.
Where a machine has other functions, such as nebulization, this standard applies only to this one. Issued on 24 July 2019, it has applied since 1 August 2020.
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Document preview — YY/T 1665-2019
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Classification and composition
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the classification, composition, requirements and test methods of vibratory slamming and smashing machines (hereinafter referred to as equipment).
This standard is applicable to the motor drive transmission soft shaft to generate vibration through the eccentric device in the power head, slamming the patient's partial chest cavity, assisting discharge Equipment for respiratory secretions. For a multi-function device (if there is atomization function), the content specified in this standard is only applicable to the device.
The function of the vibration slamming principle, other functions, if there are corresponding national standards and/or industry standards, should also comply with other relevant standards. Claim.
This standard does not apply to pneumatic pulse oscillation pumping machines.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710 Medical electrical requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 apply to this document.
3.1 Vibratory percussion sputum clearance device
The motor drive transmission shaft is vibrated by the eccentric device in the power head, slamming the patient's local chest cavity, and assisting in the discharge of respiratory secretions. device of.
3.2 Drive shaft transmissionsoftshaft
Connect the motor and the eccentric device and transfer the kinetic energy generated by the motor to the flexible shaft of the eccentric device.
3.3 Sniper patsunit
An eccentric device attached to the device that acts on the part of the patient's partial thoracic cavity through an external soft surface.
4 Classification and composition
4.1 Classification
Divided by applicable population. children, adults, children and adults. Divided by output channel. single output, multiple output. Divided by output mode. manual mode, fixed mode.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0505Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 1665-2019
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