YY/T 1035-2021Stethoscope (English PDF)

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).

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 document. 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.