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IMDRF/MC/N16FINAL:2014 IMDRF Document Format and Style Guide - PDF (75kb)

赵静曼 5/22/2022 浏览 270 IMDRF/MC/N16FINAL:2014 全球

标准简介

IMDRF Document Format and Style Guide - PDF (75kb)[附网盘链接]是于7 March 2014发布的GHTF标准，适用于全球。

标准截图

IMDRF Document Format and Style Guide - PDF (75kb)[附网盘链接]
IMDRF Document Format and Style Guide - PDF (75kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为IMDRF Document Format and Style Guide - PDF (75kb)[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 purpose of this document is to act as guidance to all those involved in developing

and issuing International Medical Device Regulators Forum (IMDRF) documents and it is

designed to be used with the accompanying Microsoft Word IMDRF Document Template. By

using the IMDRF Document Template, members involved in developing new documents will be

using a prescribed format, resulting in each new IMDRF document having a common and

consistent appearance. This in turn, will contribute to their important use in achieving

harmonized regulatory practices for medical devices around the world.

Comments or questions about the use of the Document Template or this guidance

document should be directed to the IMDRF Secretariat.

2.0 Scope

All persons involved in or responsible for the creation or issuance of IMDRF documents

are encouraged to read this document and to use the accompanying IMDRF Document Template.

The IMDRF document template was created, and should be used, in the application

Microsoft Word.

3.0 References

Throughout this document, references are made to the IMDRF document entitled “Operating

Procedures”.

4.0 Definitions

Template: the file ‘IMDRF document template.dot’

Field: a pre-formatted area of the template where specific text can be entered.

Click: one mouse click, using the primary button on the mouse

Right-click: one mouse click, using the secondary button on the mouse

Double-click: two mouse clicks, using the primary button on the mouse

5.0 Document Format

The following document format requirements have been incorporated into the IMDRF

Document Template.

7 March 2014 Page 4 of 14

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