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GHTF Principles and Practices for Medical Device Cybersecurity - PDF (951kb)

赵静曼 8/13/2022 浏览 241 GHTF 全球范围

标准简介

Principles and Practices for Medical Device Cybersecurity - PDF (951kb)[附网盘链接]是The Global Harmonization Task Force于不久之前发布的GHTF标准，适用于全球范围。

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Principles and Practices for Medical Device Cybersecurity - PDF (951kb)[附网盘链接]
Principles and Practices for Medical Device Cybersecurity - PDF (951kb)[附网盘链接](截图)

 

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标准文档类型为Principles and Practices for Medical Device Cybersecurity - PDF (951kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

1.0 Introduction

The need for effective cybersecurity to ensure medical device functionality and safety has become

more important with the increasing use of wireless, Internet, and network-connected devices.

Cybersecurity incidents have rendered medical devices and hospital networks inoperable,

disrupting the delivery of patient care across healthcare facilities. Such incidents may lead to

patient harm through delays and/or errors in diagnoses and/or treatment interventions, etc.

Stakeholders within the healthcare sector have a shared responsibility regarding medical device

cybersecurity. This guidance intends to assist all stakeholders in gaining a better understanding of

their role in support of proactive cybersecurity that helps protect and secure medical devices in

anticipation of future attacks, problems, or events.

Convergence of global healthcare cybersecurity principles and practices is necessary to ensure that

patient safety and medical device performance is maintained. To date, however, current disparate

regulations across governments lack the global alignment needed to ensure medical device

cybersecurity.

The purpose of this IMDRF guidance document is to provide general principles and best practices

to facilitate international regulatory convergence on medical device cybersecurity. The document

is structured as follows: the scope of the document is defined in Section 2 followed by defined

terms in Section 3. Section 4 provides an overview of the general principles of medical device

cybersecurity, while Sections 5 and 6 provide a number of recommendations for stakeholders

regarding best practices in the pre-market and post-market management of medical device

cybersecurity. While the pre-market section primarily addresses medical device manufacturers,

the post-market section includes recommendations for all stakeholders.

This is the first IMDRF guidance document to focus exclusively on medical device cybersecurity.

However, there are other relevant IMDRF documents which should be noted in terms of general

security considerations. IMDRF/GRRP WG/N47 FINAL:2018 provides harmonized Essential

Principles that should be fulfilled in the design and manufacturing of medical devices and IVD

1

medical devices . Those essential principles should be considered along with this guidance

document throughout the total product life cycle of a medical device. IMDRF/SaMD WG/N12

FINAL:2014 describes the importance of information security with respect to safety considerations

in Section 9.3 and illustrates some particular factors which affect the information security of

software as a medical device (SaMD).

2.0 Scope

This document is designed to provide concrete recommendations to all responsible stakeholders

on the general principles and best practices for medical device cybersecurity (including in vitro

diagnostic (IVD) medical devices). It outlines recommendations for medical device

1

Section 5.8 of N47 describes important requirements on information security and cybersecurity such as the

protection against unauthorized access. They should be considered along with this guidance document throughout

the total product life cycle of the medical device.

18 March 2020 Page 5 of 46

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