壓縮空氣質(zhì)量檢測(cè)儀URS

2020-02-09

User Requirements Specification for

Compressed Air Detector

壓縮空氣質(zhì)量檢測(cè)儀URS

Introduction/介紹

Purpose /目的

URS ID	Description/描述
	URS is the first in a series of specification documents. It provides a high level description of the user's expectation of the project scope. It details the specific requirements on compressed air detector of XXXX Co., Ltd. It determines the properties of this instrument. It also provides references for the acceptable criteria for the Qualification of this instrument. 用戶需求說(shuō)明是一系列的技術(shù)說(shuō)明中的第1個(gè)。它是用戶對(duì)項(xiàng)目范圍的預(yù)期情況進(jìn)行的高層次說(shuō)明，是對(duì)XXX有限公司壓縮空氣質(zhì)量檢測(cè)儀具體要求的詳述，決定了該設(shè)備的性能。同時(shí)為該設(shè)備的測(cè)試、驗(yàn)證提供了可接受標(biāo)準(zhǔn)依據(jù)。

URS ID

Description/描述

URS is the first in a series of specification documents. It provides a high level description of the user's expectation of the project scope. It details the specific requirements on compressed air detector of XXXX Co., Ltd. It determines the properties of this instrument. It also provides references for the acceptable criteria for the Qualification of this instrument.

用戶需求說(shuō)明是一系列的技術(shù)說(shuō)明中的第1個(gè)。它是用戶對(duì)項(xiàng)目范圍的預(yù)期情況進(jìn)行的高層次說(shuō)明，是對(duì)XXX有限公司壓縮空氣質(zhì)量檢測(cè)儀具體要求的詳述，決定了該設(shè)備的性能。同時(shí)為該設(shè)備的測(cè)試、驗(yàn)證提供了可接受標(biāo)準(zhǔn)依據(jù)。

Scope /范圍

URS ID	Description/描述
	This document is used to the URS for compressed air detector in QC Lab. 本文件用于規(guī)定QC實(shí)驗(yàn)室壓縮空氣質(zhì)量檢測(cè)儀的用戶需求說(shuō)明。

URS ID

Description/描述

This document is used to the URS for compressed air detector in QC Lab.

本文件用于規(guī)定QC實(shí)驗(yàn)室壓縮空氣質(zhì)量檢測(cè)儀的用戶需求說(shuō)明。

References /引用文獻(xiàn)

The following regulations and guidelines are referenced when compiling this document.
為編寫(xiě)本文件，參考了以下法規(guī)和指南：

Document No./文件編號(hào)	Document Title/文件標(biāo)題
1	FDA Good Manufacturing Practice for Medicinal Products (cGMP), September, 2004 FDA藥品生產(chǎn)質(zhì)量管理規(guī)范（cGMP），2004年09月
2	Monograph, USP: Medical Air 專注論文，美國(guó)藥典，醫(yī)藥用空氣
3	USP 413，Impurities testing in medical gases. 美國(guó)藥典413章節(jié)，醫(yī)藥氣體的雜質(zhì)測(cè)試
4	USP 415, Medical Gases Assay USP 415 醫(yī)藥氣體試驗(yàn)
5	GB/T 13277.1-2008 Compressed Air –Part 1 : Contaminations and purity classes GB/T 13277.1-2008 壓縮空氣第1部分：污染物凈化等級(jí)
6	ISO 8573-1, 2010 Edition ，Compressed Air –Part 1 : Contaminations and purity classes ISO 8573-1, 2010年版，壓縮空氣第1部分：污染物凈化等級(jí)
7	EP1238 Air, Medicinal EP1238空氣，藥用的

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