UpcomingMandatory
GB16174.2-2024
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 16174.2-2024 is an upcoming mandatory Chinese national standard for Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Sep 1, 2027.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the 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 Surgical Implants and Orthopedic Instruments of Standardization Administration of China