English summary · Translation available
GB16174.1-2015
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
手术植入物 有源植入式医疗器械 第1部分:安全、标记和制造商所提供信息的通用要求
GB 16174.1-2015 is a current mandatory Chinese national standard for Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. It appears in the Electronics compliance cluster with a product 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
- C30
- ICS
- 11.040.40
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Medical Electrical Equipment of Standardization Administration of China