首页 > GHTF标准 > GHTF/SG5/N7:2012

GHTF/SG5/N7:2012 GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)

赵静曼 2/27/2022 浏览 394 GHTF/SG5/N7:2012 全球

标准简介

GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)[附网盘链接]是于November 2 , 2012发布的GHTF标准，适用于全球。

标准截图

GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)[附网盘链接]
GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)[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

Study Group 5 Final Document GHTF/SG5/N7:2012

1.0 Introduction

GHTF would seek to evolve beyond convergence of regulatory requirements to embrace mutual

acceptance of common data submissions, pre-market conformity assessment processes, quality

systems, quality systems auditing results, and a broad sharing of post-marketing experience. The

objective was to allow presentation of data that are acceptable in principle to relevant authorities

as the basis for meeting regulatory requirements.

The broad goal for Study Group 5 is to promote the convergence of the regulatory requirements

for the generation and presentation of evidence of the clinical safety and performance of medical

devices. The Study Group 5 document SG5/N6 recognizes that, in order to progress convergence

of regulatory requirements and acceptance of common data, it is necessary to have a common

understanding and application of terminology, concepts and principles.

Furthermore, this document was needed to describe the process used to demonstrate clinical

evidence and to delineate when the elements of clinical evidence are appropriate for the IVD

medical device.

When placing an IVD medical device on the market the manufacturer must have demonstrated

through the use of appropriate conformity assessment procedures that the device complies with

GHTF’s Essential Principles of Safety and Performance of Medical Devices (EPs). Generally,

from a clinical perspective, it is expected that the manufacturer has demonstrated the device

achieves its intended performance during normal conditions of use in the intended environment

(e.g. laboratories, physician’s offices, healthcare centers, home environments) and in the

intended use population. As IVD medical devices are used for the examination of specimens

derived from the human body, the characteristics of clinical evidence are different from medical

devices other than IVD medical devices.

2.0 Scope

The primary purpose of this document is to provide manufacturers with guidance on how to

collect and document clinical evidence for an IVD medical device as part of the conformity

assessment procedure prior to placing an IVD medical device on the market as well as to support

its ongoing marketing. It is also intended to provide guidance to regulators and other

stakeholders when assessing clinical evidence provided by manufacturers.

This document provides the following guidance:

 general principles of clinical evidence;

 scientific validity for an analyte, when it is expected to be demonstrated and how to

document it;

 analytical performance;

 clinical performance and when it is expected;

 how to demonstrate clinical performance (e.g. studies, literature);

nd

November 2 , 2012 Page 4 of 20

网盘链接

百度网盘：https://pan.baidu.com/s/1levK1B2a6WaNb2BU1qMqRw
提取码：chvi

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：41.2465 毫秒

相关评论

相关文章