YY 0945.2-2015Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source (English PDF)

1.1 Scope

Addition.

The special provisions applicable to standard 2.1.101 defined external cardiac pacemakers with internal power requirements for the safety. This standard applies to the patient cable 2.1.104 defined.

This standard does not directly or indirectly connected to the device for the grid.

This standard does not apply to the pacing electrodes or other devices for ECG simulation.

1) becomes the internal components with other functions of the device;

2) stimulus from the outside through the chest, or esophagus;

3) to provide anti-tachycardia pacing energy at high speed;

4) provide pacing system analysis.

Each chamber dual-chamber device shall comply with the requirements of the standard.

1.2 Purpose

replace.

The specific standards for the purpose of the provisions of Security 2.1.101 requirements for defined external cardiac pacemaker.

1.3 Specific Standard

Addition.

This is a set of specific standard IEC Publication (hereinafter referred to as "General Standard" by GB 9706.1-2007, GB 9706.15-2008, YY 0505-2012, YY 0708-2009 etc.) the amendments and additions.

For simplicity, GB 9706.1 in this specific standard is referred to as "General Standard" or "General requirements" and GB 9706.15,

YY 0505 YY 0708 are juxtaposed and standards.

The term "this Standard" covers this specific standard, which together with the General Standard and Collateral Standard.

The specific standards of each chapter, and all chapters of the number corresponding to the General Standard, General Standard for changes in the terms expressed by the following provisions. "Replace" indicates that common standards chapter or completely replaced by the terms of this specific standard clauses; "Supplement" means increased specific provisions of this standard for general requirements of the standard; "Modify" means to press the special provisions of this Standard to the General Standard or modify the terms of Chapter.

General Standard for additional terms or FIG numbered starting from 101, additional annexes are numbered AA, BB, etc., additional items for the aa, bb so on.