BS EN 80001-1-2011 集合医疗设备的IT网络的风险管理应用程序.作用,职责和行为

标准号：BS EN 80001-1-2011
中文标准名称：集合医疗设备的IT网络的风险管理应用程序.作用,职责和行为
英文标准名称：Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities
标准类型：C30;C07
发布日期：2011/4/30 12:00:00
实施日期：2011/4/30 12:00:00
中国标准分类号：C30;C07
国际标准分类号：11.040.01;35.240.80
适用范围：Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirablebenefits (for example, INTEROPERABILITY), this international standard defines the roles,responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKSincorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEMSECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISKlevels.NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971. Therelationship between ISO 14971 and this standard is described in Annex A.This standard applies after a MEDICAL DEVICE has been acquired by a RESPONSIBLEORGANIZATION and is a candidate for incorporation into an IT-NETWORK.NOTE 2 This standard does not cover pre-market RISK MANAGEMENT.This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES.NOTE 3 The life cycle management activities described in this standard are very similar to those ofISO/IEC 20000-2 [10]. The relationship between ISO/IEC 20000-2 and this standard is described in Annex D.This standard applies where there is no single MEDICAL DEVICE manufacturer assumingresponsibility for addressing the KEY PROPERTIES of the IT-NETWORK incorporating a MEDICALDEVICE.NOTE 4 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation orassembly of the MEDICAL DEVICE according to the manufacturer’s ACCOMPANYING DOCUMENTS is not subject to theprovisions of this standard regardless of who installs or assembles the MEDICAL DEVICE.NOTE 5 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to thatMEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by themanufacturer, is subject to the provisions of this standard.This standard applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers andproviders of other information technology for the purpose of RISK MANAGEMENT of an ITNETWORKincorporating MEDICAL DEVICES as specified by the RESPONSIBLE ORGANIZATION.This standard does not apply to personal use applications where the patient, OPERATOR andRESPONSIBLE ORGANIZATION are one and the same person.NOTE 6 In cases where a MEDICAL DEVICE is used at home under the supervision or instruction of the provider,that provider is deemed to be the RESPONSIBLE ORGANIZATION. Personal use where the patient acquires and uses aMEDICAL DEVICE without the supervision or instruction of a provider is out of scope of this standard.This standard does not address regulatory or legal requirements.