CurrentMandatory
GB 9706.1-2020
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
医用电气设备 第1部分：基本安全和基本性能的通用要求
Explanation
GB 9706.1-2020 is a current mandatory Chinese national standard for Medical electrical equipment—Part 1: General requirements for basic safety and essential performance. It appears in the Electronics compliance cluster with a product safety focus and has an implementation date of May 1, 2023.
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
- Foundational
- CCS
- C30
- ICS
- 11.040
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Medical Electrical Equipment of Standardization Administration of China
Relationships
Replaces:GB 9706.1-2007, GB 9706.15-2008
Adopts IEC IEC 60601-1:2012 at Modified level.