English summary · Translation available
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. 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 Surgical Implants and Orthopedic Instruments of Standardization Administration of China