美利体育登录入口官网

美国 FDA 21 CFR 映射到 ISO 13485:2016 质量管理体系中适用的监管要求参考

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

应急准备实践

Emergency Preparedness Practices

石油服务中处理易燃和可燃液体的真空卡车的安全操作（第四版）

Safe Operation of Vacuum Trucks Handling Flammable and Combustible Liquids in Petroleum Service (FOURTH EDITION)

消费品召回 供应商指南

Consumer product recall — Guidelines for suppliers

用于安全应用的视频监控系统 第 4 部分：应用指南（IEC 62676-4:2014 MOD）

Video surveillance systems for use in security applications, Part 4: Application guidelines (IEC 62676-4:2014, MOD)

管理天然气管道的系统完整性

Managing System Integrity of Gas Pipelines

管理燃气管道的系统完整性 ASME 压力管道规范 B31ASME B31.8 的补充

Managing System Integrity of Gas Pipelines - ASME Code for Pressure Piping, B31. Supplement to ASME B31.8

使用基于风险的方法进行检查计划

Inspection Planning Using Risk-Based Methods

大麻/大麻产品消费者使用质量管理体系（QMS）建立的标准指南

Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products

测量建筑物、建筑系统和其他建造项目的成本风险的标准实施规程

Standard Practice for Measuring Cost Risk of Buildings and Building Systems and Other Constructed Projects

基于风险验证PAT应用程序的分析方法的标准指南

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

使用FMECA和HACCP对药品和医疗器械清洗过程进行风险识别、风险分析和风险控制的标准指南

Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices

风险管理 第3部分：技术系统风险分析指南

Risk management — Part 3 : Guide to risk analysis of technological systems

铁路应用 可靠性、可用性、可维护性和安全性（RAMS）的规范和演示 系统安全方法

Railway Applications. The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS). Systems Approach to Safety

应用于安保中的视频监控系统. 视频传输协议. 基于网络服务的IP互操作性实施

Video surveillance systems for use in security applications. Video transmission protocols. IP interoperability implementation based on Web services

电能储存（EES）系统 根据环境条件对基于电池的储能系统（BESS）的保护要求

Electrical energy storage(EES) systems - Protection requirements of battery-based energy storage systems (BESS) according to environmental conditions

工业通信网络 - 网络和系统安全 第2-1部分：建立工业自动化和控制系统安全计划

Industrial communication networks — Network and system security Part 2 - 1 : Establishing an industrial automation and control system security program

男用避孕套 关于在安全套质量管理中使用 ISO 4074 和 ISO 23409 的指南

Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

城市地区的中水回用 集中式中水回用系统指南 集中中水回用系统的管理

Water reuse in urban areas. Guidelines for centralized water reuse system. Management of a centralized water reuse system

心血管植入物 经导管心脏封堵器

Cardiovascular implants. Transcatheter cardiac occluders

家用和/或个人护理用品和其制造所用原材料/包装材料的制造用产品安全管理系统. 规格

Product safety management system for the manufacturing of home and/or personal care products and the raw/packaging materials used for their manufacture. Specification

社区灾害风险地图制作规范

Specifications for making community disaster risk maps

商场突发事件应急管理规范

Emergency management regulations for shopping mall emergencies

桥（门）式起重机安全评估规范

Code for Safety Evaluation of Bridge (Portal) Cranes

工贸企业检维修作业安全规范

Safety Standards for Maintenance and Repair Operations in Trade and Manufacturing Enterprises

电梯安全评估规范

Elevator safety assessment standards

医疗器械清洁度 工艺设计和试验方法

Cleanliness of medical devices - Process design and test methods; Text in German and English

民用炸药雷管和导爆索继电器第27部分：电子起爆系统的风险分析和试验方法

Explosives for civil uses - Detonators and detonating cord relays - Part 27: Risk analysis and test methods for electronic initiation systems; German and English version prEN 13763-27:2021 / Note: Date of issue 2021-10-22*Intended as replacement for DI...

娱乐潜水服务.娱乐潜水服务提供者的要求

Recreational diving services - Requirements for recreational scuba diving service providers; German version EN 14467:2004

压力美利体育官网首页网址 第7部分：不用火加热的压力美利体育官网首页网址用安全系统（草案）

Pressure equipment - Part 7: Safety systems for unfired pressure equipment

一次性使用无菌导尿管（草案）

Disposable sterile urinary catheter (draft)

心血管植入物 心脏瓣膜假体 第1部分：一般要求（ISO/DIS 5840-1:2019）

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO/DIS 5840-1:2019); German and English version prEN ISO 5840-1:2019

铁路电信号系统

Electric signalling systems for railways

信息技术 系统及软件完整性级别

Information technology--System and software integrity levels

良好农业规范 第1部分;术语

Good agricultural practice.Part 1:Terminology

进出境植物和植物产品有害生物风险分析工作指南

Guideline for pest risk analysis of import and export plant and plant product

电气美利体育官网首页网址的安全.风险评估和风险降低.第2部分:风险分析和风险评价

Electrical equipment for safety.Risk assessment and risk reduction.Part 2:Risk analysis and risk evaluation

食品微生物指标制定和应用的原则

Principles for the establishment and application of microbiological criteria for foods

信息安全技术 灾难恢复中心建设与运维管理规范

Information security technology.Construction and sustain management specifications of disaster recovery center

平流层飞艇测试安全性要求

Safety requirements for stratospheric airship testing

医学实验室 风险管理在医学实验室的应用

Application of medical laboratory risk management in medical laboratories

电磁兼容 风险分析方法 第1部分：电缆屏蔽

Electromagnetic Compatibility Risk Analysis Methods Part 1: Cable Shielding

装备研制风险分析要求

Risk analysis requirements for materiel development

风险管理.技术系统风险分析

Risk management. Risk analysis of technological systems

系统工程 在业务分析或系统分配期间保护信息

System engineering. Protection of information in system business or mission analysis process

铁路应用：可靠度、可用度、可维修度和安全性的规范与验证 第2部分：系统级的安全方法

Railway applicationspecification and demonstration of reliability, availability, maintainability and safety [RAMS] - Part 2: Systems approach to safety

电储能系统(EES) 第4-3部分：根据环境条件的电池储能系统(BESS)保护要求

Electrical energy storage (EES) systems - Part 4-3: Protection requirements for battery energy storage systems (BESS) according to environmental conditions

电气储能(EES)系统 第4-3部分：根据环境条件的电池储能系统(BESS)保护要求

Electrical energy storage (EES) systems – Part 4-3: Protection requirements of battery-based energy storage systems (BESS) according to the environmental conditions

环境质量 基于风险的纠正措施（ACBR）应用于受碳氢化合物污染场地 方法论指南

Environmental quality. Risk-based corrective actions applied to petroleum contaminated sites (RBCA). Methodological guide.

软件和系统工程.软件安全和安全验证工具的能力

Software and systems engineering — Capabilities of software safety and security verification tools

信息技术.安全技术.网络安全.第1部分:概述和概念

Information technology - Security techniques - Network security - Part 1: Overview and concepts

血管内通路装置颗粒物污染的风险管理

Risk management of particulate contamination for devices with intravascular access

医疗装置.风险管理.第1部分:风险分析的应用

Medical devices -- Risk management -- Part 1: Application of risk analysis

电能储能系统（EES） 第4-3部分：基于环境条件的电池储能系统（BESS）的保护要求（IEC 62933-4-3:2025）

Electrical energy storage (EES) systems - Part 4-3: Protection requirements of battery-based energy storage systems (BESS) according to environmental conditions (IEC 62933-4-3:2025)

林业有害生物风险分析准则

Guidelines for the pest risk analysis (PRA) in forestry

外来昆虫风险分析技术规程.椰心叶甲

Code of practice of risk analysis for alien insect Brontispa longissima(Gestro)

外来昆虫风险分析技术规程.红棕象甲

Code of practice of risk analysis for alien insect.Rhynchophorus ferrugineus(Olivier)

外来植物风险分析技术规程.飞机草

Code of practice of risk anaylsis for alien plant.Chromolaena odorata(L.)R.M.King and H.Robinson

活动物跨省调运风险分析指南

Risk analysis guide for cross-provincial transportation of live animals

热喷涂.热喷涂美利体育官网首页网址的安全要求.第1部分:通用要求

Thermal spraying - Safety requirements for thermal spraying equipment - Part 1: General requirements

医用电气美利体育官网首页网址通用测试程序

General testing procedures for medical electrical equipment

本质更安全设计指南[新实践]

Inherently Safer Design Guide [New Practice]

国境口岸外来医学媒介生物风险分析规则

Rules of risk analysis for imported medical vectors at frontier ports

进出口机电产品检验 专业通用要求 第2部分：风险评价

General requirements of inspection on electrical and mechanical products for import and export.Part 2:Risk assessment

进出境动物和动物产品风险分析程序和技术要求

Procedure and technical requirement of risk analysis for entry and exit animal and animal product

引进生物防治物风险分析规则

Rules for risk analysis of introducing bio-control agents

由现代生物技术获得的食品的风险分析准则

Principles for the risk analysis of foods derived from modern biotechnology

生物技术 研究、开发和分析实验室 转基因植物控制指南

Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants?

固体生物燃料 在商业和工业应用中安全处理和储存固体生物燃料颗粒（ISO 20024:2020）

Solid biofuels - Safe handling and storage of solid biofuel pellets in commercial and industrial applications (ISO 20024:2020)

化妆品 微生物学 微生物学检查的通用说明（ISO 21148:2017）

Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

安全压力保护装置 第9部分：安全装置的应用和安装（不包括独立爆破盘安全装置）(ISO 4126-9:2008, IDT)

Safety devices for protection against excessive pressure - Part 9: Application and installation of safety devices excluding stand-alone bursting disc safety devices (ISO 4126-9:2008, IDT)

多旋翼无人机系统安全性分析规范

Safety analysis specification for unmanned aircraft systems with multi-rotors

程序可控元件用软件

UL Standard for Safety Software in Programmable Components (Third Edition)

建筑防雷设计规范

Design Specification for Lightning Protection of Buildings and Structures

Flow battery systems for stationary applications - Part 2-2: Safety requirements (IEC 21/901/CD:2016)

Flussbatterie-Systeme fuer stationaere Anwendungen - Teil 2-2: Sicherheitsanforderungen (IEC 21/901/CD:2016)

带电作业 适用于工具 装置和美利体育官网首页网址的合格评定（IEC 78/1203/CD:2018）

Live working - Conformity assessment applicable to tools@ devices and equipment (IEC 78/1203/CD:2018); Text in German and English

再加工过程中的： 医疗器械再加工的风险管理 风险控制措施

Reprocessing hazards Risk management in reprocessing of medical devices Measures for risk control

对医疗用途中的有源医疗器械进行重复测试 测试原则

Retesting of active medical devices in medical use - Testing principles