GB 16174.2-2015

Active

Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

手术植入物 有源植入式医疗器械 第2部分:心脏起搏器

Standard Type
GB
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2015-12-10
Implementation
2017-07-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

GB 16174.2-2015 specifies safety, performance, and testing requirements for active implantable cardiac pacemakers. It is applied in the medical device industry for the design, manufacturing, and regulatory compliance of pacemakers used to treat arrhythmias. This standard ensures device reliability and patient safety during clinical implantation and long-term use.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.