T/CSBME 005-2019 Active Group standards

T/CSBME 005-2019 Medical teaching trauma simulator - Part 1: General technical requirements for models

Publish Date: 2019-07-11 Implement Date: 2019-08-01 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 005-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2019-07-11

Implement Date: 2019-08-01

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. This standard applies 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: This standard specifies the performance requirements for the medical teaching trauma simulation manikin model, but does not make special provisions for electrical safety. This standard makes a series of provisions for the composition of the manikin, control hardware, software systems (such as operation modes, accompanying case systems, clinical medical equipment interfaces, trauma modules, etc.), as well as the normal working conditions of the manikin, appearance and structure, functions, material connection stability, working time, safety, environmental adaptability, and corresponding test methods, markings, certificates of conformity, user manuals, packaging, transportation, and storage.

Development Information

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24