本标准规定了集成设备的一般要求、模型和框架，以创建3.6中定义的集成临床环境（ICE）。本标准规定了通过电子接口将来自不同制造商的医疗设备和其他设备安全集成到单个医疗系统中所需的特性，以护理单个高视力患者。本标准规定了医疗系统的要求，与独立使用的医疗设备相比，医疗系统具有更大的抗误码能力，并改善了患者安全性、治疗效果和工作流程效率。这一系列标准确立了模型设计、验证和确认过程的要求- 基于集成系统的集成临床环境。本系列标准旨在定义对安全至关重要的要求，从而促进监管机构的认可。

This standard specifies general requirements, a model, and framework for integrating equipment to create an INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy, and workflow efficiency than can be achieved with independently used MEDICAL DEVICES. This series of standards establishes requirements for design, verification, and validation processes of a model-based integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance.