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CurrentMandatory

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.