GB/Z 40842-2021 Active National standards

GB/Z 40842-2021 General technical requirenments for electrolarynx

Publish Date: 2021-10-11 Implement Date: 2021-10-11 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/Z 40842-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Resistor

ICS Name: Electroacoustics

Publish Date: 2021-10-11

Implement Date: 2021-10-11

Pages: 9 pages

Scope

This document specifies the technical requirements, test methods, inspection rules, marking, labeling, packaging, transportation, and storage of electronic artificial larynxes. This document is applicable to the production, use, and distribution of electronic artificial larynxes. It is suitable for patients who have lost their ability to speak due to laryngectomy surgeries caused by diseases or accidents, etc.

Development Information

Word Count: 20 Thousand words Pages: 9 pages

Referenced Standards

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 GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 10111-1988 Methods for random sampling by utilizing dices of random number GB/T 10111-2008 Generation of random numbers and procedures applied to sampling inspection for product quality GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests GB/T 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

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GB/T 4128-1995 Active

GB/T 4128-1995 Acoustics—Standard hydrophone

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GB/T 15953-1995 Replaced

GB/T 15953-1995 Instruments for the measurement of aural acoustic impedance/admittance

Publish Date: 1995-12-21

GB/T 16540-1996 Active

GB/T 16540-1996 Acoustics—Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz—Hydrophone method

Publish Date: 1996-09-09

YY/T 0458-2003 Replaced

YY/T 0458-2003 Technical requirements for ultrasonically blood-mimicking Doppler phantom

Publish Date: 2003-06-20

GB/T 20441.4-2006 Active

GB/T 20441.4-2006 Measurement microphones—Part 4:Specifications for working standard microphones

Publish Date: 2006-08-23