English summary · Translation available
GB9706.216-2021
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
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. Request a translation or verify 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.