English summary · Translation available
CurrentMandatoryUpcoming replacement
GB16174.2-2015
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
GB 16174.2-2015 is a current mandatory Chinese national standard for Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers. It appears in the Electronics compliance cluster with a electrical safety focus and has an implementation date of Jul 1, 2017.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Request a translation or verify source before using this record in a compliance decision.
Applicability hints
- Type
- Product
- CCS
- C35
- ICS
- 11.040.40
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Medical Electrical Equipment of Standardization Administration of China
Relationships
Replaces:GB 16174.1-1996
Replaced by:GB 16174.2-2024 (Upcoming)
Adopts ISO ISO 14708-2:2005 at Identical level.