YY/T 0868-2021Electrodes for nerve and muscle stimulators (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0868-2011 "Electrodes for nerve and muscle stimulators", the main changes compared with YY/T 0868-2011 Change as follows.

---Modified the content of normative references (see Chapter 2, Chapter 2 of the.2011 edition);

---Modified terms and definitions (see 3.1, 3.1 in the.2011 edition);

---Modified the impedance requirements (see 4.2.1, 4.2.1 of the.2011 edition);

---The temperature requirement is deleted (see 4.2.2 of the.2011 edition);

---Added the requirements for the stickiness of the hydrogel sheet electrode (see 4.2.2.1);

---Added the requirements for the flexibility of the hydrogel sheet electrode (see 4.2.2.2);

---Modified the connection requirements (see 4.2.3, 4.2.3 of the.2011 edition);

---Added the requirements for the stability of the non-detachable electrode connection line (see 4.2.4);

--- Deleted the requirements for the cross-sectional area of the electrode connection line (see 4.2.4 of the.2011 edition);

---The requirements for microorganisms have been added (see 4.2.7);

---Modified the biocompatibility (see 4.3, 4.3 in the.2011 edition);

---Modified the sterility test method (see 5.2.5, 5.2.5 of the.2011 edition).

1 Scope

This standard specifies the terms, definitions, requirements, and test methods for electrodes for nerve and muscle stimulators (hereinafter referred to as electrodes).

This standard applies to electrodes for nerve and muscle stimulators.

This standard does not apply to electro-acupuncture, fili-needle, and electrodes that only contain acupoint detection function in Chinese medicine.

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/T 3280-2015 stainless steel cold-rolled steel plate and strip

GB 9706.1-2020 Medical electrical equipment Part 1: General requirements for basic safety and basic performance

GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1: Chemical analysis methods

GB 15979-2002 Hygienic standard for disposable sanitary products

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management

YY 9706.210-2021 Medical electrical equipment Part 2-10.Basic safety and basic performance of nerve and muscle stimulators Use requirements "The Pharmacopoeia of the People's Republic of China".2015 Edition Four

3 Terms and definitions

The following terms and definitions defined in YY 9706.210-2021 apply to this document.

4 Requirements