YY/T 0196-2005
Disposable ECG electrodes (English Version)

Standard No.

YY/T 0196-2005

Language

Chinese, Available in English version

Release Date

2005

Published By

Professional Standard - Medicine

Latest

YY/T 0196-2005

Replace

YY/T 0196-1994

Scope

This standard specifies the minimum requirements for the marking, safety and performance of single-use electrodes used in diagnostic electrocardiographs or ECG monitoring. Any single-use ECG electrode system consisting of a sensing element and an electrolyte (see 3.4) is included in the scope of this standard. Active electrodes, needle electrodes, reusable (non-disposable) electrodes, electrodes used to deliver energy and electrodes primarily designed to measure physiological electrical signals other than ECG (for example: used in non-cardiac apnea monitoring) Electrodes for electrical purposes, such as resistance tracing) are not included in the scope of this standard. Requirements regarding electrolyte composition are also outside the scope of this standard.

YY/T 0196-2005 Referenced Document

• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
• GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
• GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
• GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
• GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
• GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements *， 2011-12-30 Update
• GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices*， 2015-12-10 Update
• GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
• GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
• GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
• GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
• GB/T 191-2000 Packaging-Pictorial marking for handling of goods
• GB/T 2828-1987 Batch-by-batch inspection counting sampling procedure and sampling table (applicable to continuous batch inspection)
• GB/T 2829-1987 Periodic inspection counting sampling procedure and sampling table (applicable to the inspection of the stability of the production process)

YY/T 0196-2005 history

• 2005 YY/T 0196-2005 Disposable ECG electrodes
• 1994 YY/T 0196-1994 Disposable ECG electrodes