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YY/T 1035-2021: Stethoscope
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1035-2021 | English | 209 |
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Stethoscope
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YY/T 1035-2021
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PDF similar to YY/T 1035-2021
Standard similar to YY/T 1035-2021 GB/T 19701.1 GB 9706.227 YY/T 1519 Basic data | Standard ID | YY/T 1035-2021 (YY/T1035-2021) | | Description (Translated English) | Stethoscope | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C38 | | Word Count Estimation | 11,192 | | Issuing agency(ies) | State Drug Administration | YY/T 1035-2021: Stethoscope---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Stethoscope
ICS 17.140.50
C38
People's Republic of China Pharmaceutical Industry Standards
Replace YY 91035-1999, YY/T 91077-1999
Stethoscope
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 2
5 Test method 3
6 Appendix A (Normative Appendix) Stethoscope Frequency Response Curve---Test Method for Air Vibration Sensor 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 91035-1999 "Stethoscope" and YY/T 91077-1999 "Test Method for Sound Transmission Characteristics of Stethoscope", and
The main changes compared to YY 91035-1999 are as follows.
---Modified the scope of application of the standard, and electronic stethoscopes also belong to the category of stethoscopes (see Chapter 1, Chapter 1 of the.1999 edition);
---The requirements for electroplated parts of the stethoscope have been revised (see 4.1.5, 4.12 of the.1999 edition);
---Modified the attenuation limit of the frequency response curve of the sound attenuating stethoscope (see 4.2.2, 4.2.2 of the.1999 edition);
---Modified the elasticity and elasticity limit requirements and test methods of earrings (see 4.3, 4.5 and 4.6 of the.1999 edition);
---The requirements for sound transmission connection ducts have been revised (see 4.4, 4.7 of the.1999 edition);
--- Added the explanation of terms and definitions (see Chapter 3);
---Added special performance requirements for electronic stethoscopes (see 4.2.3);
---Added electrical safety, electromagnetic compatibility, biocompatibility, environmental adaptability requirements (see 4.5, 4.6, 4.7, 4.8);
--- Deleted the drawings and document manufacturing approved in accordance with the prescribed procedures in the original standard (see 4.1 in the.1999 edition);
--- Deleted the surface roughness requirements of electroplated parts in the original standard (see 4.11 in the.1999 edition);
--- Deleted Chapter 6 "Inspection Rules" in the original standard (see Chapter 6 of the.1999 edition).
Compared with YY/T 91077-1999, the main changes are as follows.
--- Added the explanation of terms and definitions (see Chapter 3);
---Modified the non-linear distortion coefficient index when the sound pressure level reaches 110dB (see A.1.1.2, 2.2 in the.1999 edition);
--- Modified the description of "coupling cavity" and changed to "ear simulator" (see A.1.1.3,.1999 edition 2.3);
---Modified the test environment and increased the test background noise requirements (see A.2.1, Chapter 3 of the.1999 edition);
---Added the frequency response test mode (see A.3.2, 4.2 in.1999 edition);
--- Increase the test requirements for equivalent input noise level and total harmonic distortion (see A.3.2.2 and A.3.2.3, 4.2 in the.1999 edition);
--- Delete some old test instruments and methods (see 2.11 in the.1999 edition).
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the unit responsible for the standardization of medical electro-acoustic equipment and medical equipment.
Drafting organizations of this standard. Jiangsu Medical Device Inspection Institute, Shanghai Medical Device Inspection Institute, Jiangsu Yuyue Medical Equipment Co., Ltd.
Division, Jiangsu Lude Medical Electronics Co., Ltd., Guangdong Hanhong Medical Technology Co., Ltd.
The main drafters of this standard. Hu Jimin, Zhang Yichuan, Liu Ru, Wang Dawei, Zhang Haimin, Deng Guoxin, Zhu Zengkai, Jiang Lielong, Huang Zhenjiang, Wang Hao,
Huang Yixin, Yang Hongguang.
The previous editions of the standards replaced by this standard are as follows.
---GB 11237-1989,ZBC38002-87;
---YY 91035-1999,YY/T 91077-1999.
Stethoscope
1 Scope
This standard specifies the terms and definitions, requirements, and test methods of stethoscopes.
This standard applies to stethoscopes, including electronic stethoscopes.
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 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 16886 (all parts) Biological evaluation of medical devices
YY/T 0076 Technical requirements for coating classification of metal parts
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance
Content requirements and tests
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
A device used to listen to the sound changes of the human heart, lungs and other organs.
3.2
A stethoscope that uses electronic devices to fulfill its functions.
3.3
Stethoscope with electronic amplification function.
3.4
Stethoscope without electronic magnification function.
3.5
Acousticsourceformeasurement
When testing the sound transmission characteristics of the stethoscope, the distortion is small, the frequency response is flat (compression can be used), and the sound pressure level meets certain requirements
Sound source.
3.6
Under the specified test sound source conditions, the relationship between the output sound pressure level of the stethoscope and the frequency of the test sound source.
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