Medical electrical equipment -- Part 1: General requirements for safety
Sector / Industry
National Standard
Classification of Chinese Standard
C30
Classification of International Standard
11.040
Word Count Estimation
146,114
Date of Issue
2007-07-02
Date of Implementation
2008-07-01
Older Standard (superseded by this standard)
GB 9706.1-1995
Adopted Standard
IEC 60601-1-1988, IDT
Regulation (derived from)
China Announcement of Newly Approved National Standards No. 8, 2007 (No. 108 overall)
Issuing agency(ies)
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary
This Chinese standard applies to medical electrical equipment (see Definition 2. 2. 15) security. Although this standard is mainly related to security issues, but it also includes some security-related requirements for reliable operation. Equipment covered by this standard are expected physiological effects caused by the security aspects were not considered dangerous. Unless expressly stated in the body of the standard, the standard in the appendix does not require enforcement.
