DIN EN ISO 8536-8-2015

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015); German version EN ISO 8536-8:2015

发布日期：2015-11-01  实施日期：2015-11-01

ISO/IEC Guide 63-1999

医疗器械安全方面的开发并纳入国际标准指南

Guide to the development and inclusion of safety aspects in International Standards for medical devices

发布日期：1999-02-01  实施日期：1999-02-01

BS EN 60627-2015

Diagnostic X-ray imaging equipment. Characteristics of general purpose and mammographic anti-scatter grids

发布日期：2015-06-30  实施日期：2015-06-30

ISO 11197-2016

Medical supply units

发布日期：2016-02-01  实施日期：2016-02-01

ISO/IEEE 11073-10419-2016

Health informatics - Personal health device communication - Part 10419: Device specialization — Insulin pump - First Edition

发布日期：2016-06-15  实施日期：2016-06-15

ISO 14408-2016

Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information

发布日期：2016-02-01  实施日期：2016-02-01

IEC 60645-1-2012

电声学 测听设备 第1部分:纯音听力计

Electroacoustics. Audiometric equipment. Part 1:Equipment for pure-tone audiometry

实施日期：2012-02-16

NF C74-331-2003

医用电气设备.第2部分:外科手术台的安全特殊要求

Medical electrical equipment - Part 2-46 : particular requirements for the safety of operating tables.

ISO 11990-1-2011

激光器和激光相关设备 气管导管激光抗性的测定 第1部分:气管导管轴

Lasers and laser-related equipment -- Determination of laser resistance of tracheal tubes -- Part 1: Tracheal tube shaft

发布日期：2011-08-01  实施日期：2011-08-01

BS PD IEC/TR 80001-2-5-2014

Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on distributed alarm systems

发布日期：2015-01-31  实施日期：2015-01-31

BS EN 80601-2-35-2009+A11-2011

Medical electrical equipment. Part 2-35:Particular requirements for the basic safety and essential performance of heating devices using blankets,pads and mattresses and intended for heating in medical use AMD:February 29,2012

实施日期：2011-01-01

BS EN 60613-2010

Elektrische und Belastungs-Kennwerte von R?ntgenstrahlern für die medizinische Diagnostik Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis Caractéristiques électriques et de charge des gaines équipées pour diagnostic médical

实施日期：2010-05-31

EN ISO 5367-2014

Anaesthetic and respiratory equipment - Breathing sets and connectors

实施日期：2014-10-01

DIN EN 60336-2006

医用电气设备 医用诊断X射线管组件 焦点特性

Medical electrical equipment - X-ray tube assemblies for medical diagnosis Characteristics of focal spots

实施日期：2006-09-01

ISO/TR 28380-3-2014

Health informatics -- IHE global standards adoption -- Part 3: Deployment

发布日期：2014-12-18  实施日期：2014-12-18

ASTM G128-2002(2008)

氧气浓缩系统危害与风险控制指南

Standard Guide for Control of Hazards and Risks in Oxygen Enriched Systems

实施日期：2002-03-10

BS ISO 13926-2-2011

Pen-Systeme. Kolbenstopfen für Pen-Injektoren zur medizinischen Verwendung Pen systems Part 2:Plunger stoppers for pen-injectors for medical use Systèmes de stylos-injecteurs. Bouchons-pistons pour stylos-injecteurs. usage médical

实施日期：2011-04-30

DIN EN ISO 14971-2009

医疗设备 对医疗设备风险管理的应用

Medical devices - Application of risk management to medical devices

实施日期：2009-10-01

BS EN ISO 11990-1-2014

光学和光学仪器 气管激光抗性的测定 气管导管轴

Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes. Tracheal tube shaft

发布日期：2014-11-30  实施日期：2014-11-30

DIN EN ISO 10651-2-2011

Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 2:Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2009