A document used to justify that a machine, a device or a system complies with relevant technical regulations and safety requirements throughout its design, manufacturing, installation, operation, and maintenance processes. Through detailed risk assessments, technical analyses, and compliance verification, it ensures the safety of the equipment throughout its entire lifecycle.
Followings are the details of Safety Justification / Safety Case:
以下是关于安全论证/安全案例的详细解读：
1. Definition of Safety Justification / Safety Case
A “Safety Justification” (also known as a “Safety Case”) is a structured and systematic document that justified how a piece of equipment or a system meets specific safety objectives and requirements. It typically includes risk assessments, design analyses, operating instructions, test reports, and other supporting materials, with the aim of providing comprehensive evidence of the equipment’s safety.
Test Reports — Presents the results of relevant tests and verifications performed on the equipment.
Proof of Conformity — Demonstrates that the equipment meets the specific requirements of applicable technical regulations.
2. 安全论证的核心内容
安全论证通常包括以下关键部分：
风险评估 - 识别设备在操作中的潜在危险源，并计算风险程度。
设计文件 - 包含设备的图纸、规格和计算等信息。
操作文件 - 设备的操作说明、维护要求及安全措施。
测试报告 - 设备通过的相关测试和验证结果。
符合证明 - 证明设备满足技术法规的具体要求。
3. Purpose and Value of a Safety Justification
Demonstrating Compliance — Provides evidence that the equipment complies with technical regulations.
Supporting Certification Applications — Serves as one of the foundational documents for international/national certification or a declaration of conformity.
Ensuring Safety — Ensures safe operation throughout the equipment’s lifecycle through risk assessment and safety measures.
Enhancing User Confidence — Builds user trust through detailed safety analysis and transparent documentation.
