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CurrentMandatory

GB9706.245-2020

Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices

医用电气设备 第2-45部分:乳腺X射线摄影设备和乳腺摄影立体定位装置的基本安全和基本性能专用要求

GB 9706.245-2020 is a current mandatory Chinese national standard for Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices. 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
C43
ICS
11.040.50
Competent department
National Medical Products Administration
Technical committee
National Medical Products Administration

Relationships

Replaces:GB 9706.24-2005

Adopts IEC IEC 60601-2-45:2015 at Modified level.