GB 9706.216-2021
Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备 第2-16部分：血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求
Explanation
GB 9706.216-2021 is a current mandatory Chinese national standard for Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. 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
- Safety
- CCS
- C45
- ICS
- 11.040.20
- Competent department
- National Medical Products Administration
- Technical committee
- National Medical Products Administration
Relationships
Replaces:GB 9706.2-2003
Adopts IEC IEC 60601-2-16:2018 at Modified level.