CurrentMandatoryUpcoming replacement
GB 16174.2-2015
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
Explanation
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. Verify against the official 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.