T/CSBME 009-2019 Active Group standards

T/CSBME 009-2019 Medical device network security quality evaluation method

Publish Date: 2019-11-15 Implement Date: 2020-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 009-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Other medical equipment

Publish Date: 2019-11-15

Implement Date: 2020-03-01

Scope

Scope: This standard specifies the performance requirements for the medical teaching trauma simulation manikin model, but does not make special provisions for electrical safety. The medical teaching trauma simulation manikins specified in this standard are applicable to medical rescue simulation training operations, including indoor and outdoor trauma emergency treatment training operations (such as hemostasis, bandaging, fixation, carrying, cardiopulmonary resuscitation, ventilation, etc.) and product testing requirements; Main technical content: The purpose of this standard is to evaluate and consider medical device products (including software and hardware) in a network environment from the perspective of network security. This standard makes relevant provisions in terms of terms and definitions, technical requirements (attached documents, product design requirements, product function requirements), and compliance evaluation rules (attached document compliance evaluation, product design requirements compliance evaluation, product function requirements compliance evaluation).