GB/Z 40842-2021General technical requirenments for electrolarynx (English PDF)

1 Scope

GB/Z 40842-2021 is the Chinese national standard on general technical requirenments for electrolarynx, in the field of metrology and measurement. The /Z suffix marks it as a guiding technical document: it does not prescribe requirements that can be certified against, but sets out the technique, the method or the state of the art that the standards bodies recommend following. It was issued on 11 October 2021 by the State Administration for Market Regulation; Standardization Administration of China. As a guiding technical document it carries no separate date of entry into force: it applies from publication. Classification: ICS 17.140.50, CCS L13. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This document specifies the technical requirements, test methods, inspection rules, marks, labels, packaging, transportation, and storage of the electrolarynx. This document applies to the production, use, and distribution of the electrolarynx. It is suitable for patients who have received laryngectomy and lost vocal function due to diseases, accidents, and other reasons.

2 Normative references

The following documents contain the provisions which, through normative reference in this document, constitute the essential provisions of this document. For the dated referenced documents, only the versions with the indicated dates are applicable to this document; for the undated referenced documents, only the latest version (including all the amendments) is applicable to this document.

GB/T 191 Packaging - Pictorial marking for handling of goods

GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

GB/T 10111 Generation of random numbers and procedures applied to sampling inspection for product quality

GB/T 14710 The environmental requirement and test methods for medical electrical equipment

GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 electrolarynx A voice recovery device powered by a battery.

Note: It can transmit the vibrating sound signal to the pharynx through the patient's neck tissue, and the signal is modulated by the upper part of the vocal tract to form an electronic artificial laryngeal voice at the lip end; it belongs to the speech compensation rehabilitation aids.

3.2 external electrolarynx A voice recovery device whose vibration device is located outside the body, and the vibration signal is transmitted to the oral cavity through the neck tissue or the sound transmission tube.

3.3 Internal electrolarynx A voice recovery device whose vibration device is located in the body, and the vibration signal directly forms in the mouth.

3.4 vibrating membrane A component of an electrolarynx, which can be pressurized by electromechanical control and cause vibration and sound.

3.5 volume adjuster A device that can adjust the sound intensity of an electrolarynx.

3.6 pitch adjuster A device that can adjust the vibration frequency of a vibrating membrane.

3.7 laser measuring micro-displacement instrument An instrument that can directly measure the vibration frequency of a vibrating membrane.

3.8 vibration measuring instrument An instrument that uses mechanical means, optical means, vibration sensors, etc. to measure the vibration amplitude, acceleration, speed, and frequency of objects.

Note: The vibration measurement accuracy should be less than 100 µm, and the measurement range

4.3.2 After the test sample is subjected to the button life test according to the method specified in 5.3.2, the fundamental frequency of the sample shall not exceed ±10% of the fundamental frequency before the test.

4.4 Packaging requirements The test sample (with packaging) shall be able to work normally after being tested according to the method in 5.4.

4.5 Environmental adaptability The environmental test of the electrolarynx shall meet the requirements of GB/T 14710.

4 Technical requirements...

5 Inspection methods

5.1 Inspection methods for appearance and structure The method can be visual inspection and touch detection, which shall meet the requirements of 4.1.

7 Marks and labels

7.1 The following information shall be marked in the appropriate position of an electrolarynx:

a) Manufacturer's name, trademark;

b) Product name and model;

c) Product number or date of manufacture;

d) Supply voltage;

e) The fundamental frequency range over which the product operates;

f) The medical device registration certificate number or filing document number.

7.2 There shall be a certificate of quality in the packing box, and the certificate of quality shall contain the following contents:

a) Name of the manufacturer;

b) Product name and model;

c) Date of inspection;

d) Product number;

e) Inspector code;

f) The word "Qualified".