YY 0885-2013Medical electrical equipment - Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems (English PDF)

1.1 Scope

Addition.

This standard specifies the special safety requirements applicable to specific definitions of 2.101 Holter system.

The following types of systems within the scope of this standard.

Gives basic when a) continuous ECG recording and analysis system, and the system for a complete re-analysis of ECG The same results. The system can be recorded and stored electrocardiogram, and then in a separate unit for analysis or record And analysis at the same time. This standard does not involve the use of the type of storage media;

b) to provide continuous analysis and partial or limited record, but not a complete re-ECG analysis system.

Meet any of these types of systems are applicable to the standard safety requirements.

If Holter ECG analysis system provides automated, the applicable minimum performance requirements of this standard of measurement and analysis functions.

By the GB 10793-2000 and GB 9706.25-2005 covered medical electrical equipment not within the scope of this standard.

This standard does not apply to the ECG can not be continuous recording and analysis system (for example, "intermittent event recorders").

1.2 Purpose

replace.

The specific standard is intended to develop specific requirements for Holter system safety and essential performance.

1.3 Specific Standard

Addition. The specific reference standard GB 9706.1-2007.

It said in this specific standards in Part 1 of the "General Standard" or "General requirements." 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 provision. "Supplement" means this specific standard provisions to increase the general standard. "Modify" means to press the special provisions of this Standard to the General Standard or chapter shall be modified.

General Standard for additional terms or FIG numbered starting from 101, additional annexes are lettered as AA, BB, etc., increased column items As aa), bb) and the like.

The term "this standard" is used to refer to the General Standard and this Particular Standard collectively.

When universal standard articles, chapters and bars without the corresponding articles, chapters and clauses in this specific standard, even may not be relevant, and no change to Be applicable.