2024年4月28日发(作者：)

PA/PH/OMCL (18) 24 R1 -- QUALIFICATION OF EQUIPMENT --QUALIFICATION OF IR SPECTROPHOTOMETERS 201909

General European OMCL Network (GEON)

QUALITY MANAGEMENT DOCUMENT

PA/PH/OMCL (18) 24 R1

QUALIFICATION OF EQUIPMENT

QUALIFICATION OF IR SPECTROPHOTOMETERS

仪器确认—红外光谱仪确认

Full document title

and reference

文件全名和索引号

Document type

文件类型

Legislative basis

立法基础

Date of first adoption

首次采纳日期

Date of original entry

into force

首次执行日期

Date of entry into

force of revised

document

修订后执行日期

Previous titles/other

references / last valid

version

原文件名/其它索引号

Custodian

Organisation

托管机构

Concerned Network

相关网络

Qualification of Equipment

Annex 4: Qualification of IR Spectrophotometers PA/PH/OMCL (18) 24 R1

仪器确认 附录4：红外光谱仪确认 PA/PH/OMCL (18) 24 R1

Guideline

指南

The present document was also accepted by EA as recommendation

document to be used in the context of Quality Management System audits

of OMCLs

本文亦由EA接受作为建议文件，将用于OMCL的质量管理体系审计

May 2007

2007年5月

July 2007

2007年7月

September 2019

2019年9月

This document replaces document PA/PH/OMCL (07) 12 DEF CORR in

force since December 2007

本文取代2007年12月起执行的PA/PH/OMCL (07) 12 DEF CORR

The present document was elaborated by the OMCL Network / EDQM

of the Council of Europe

本文件由欧洲委员会OMCL网络/EDQM

GEON

GEON

PA/PH/OMCL (18) 24 R1 – 设备确认 –红外光谱仪确认 201909 译文件仅供参考 翻译：JULIA 页 1 / 6

PA/PH/OMCL (18) 24 R1 -- QUALIFICATION OF EQUIPMENT --QUALIFICATION OF IR SPECTROPHOTOMETERS 201909

ANNEX 4 OF THE OMCL NETWORK GUIDELINE

“QUALIFICATION OF EQUIPMENT”

QUALIFICATION OF IR SPECTROPHOTOMETERS

OMCL网络指南“仪器确认”附录4

红外光谱仪确认

Note: Mandatory requirements in this guideline are defined using the terms “shall” or “must”. The use of

“should” indicates a recommendation. For these parts of the text other appropriately justified approaches

are acceptable. The term “can” indicates a possibility or an example with non-binding character.

注：本指南中的强制规定采用“应（SHALL）”或“必须（MUST）”来表示。“应该（SHOULD）”一词

表示建议。本文中的要求可通过经过论证的适当方法替代。术语“可（CAN）”表示一种可能性或非强制特

点举例。

1. INTRODUCTION 前言

The present document is the 4

Annex of the core document “Qualification of Equipment”, and it shall be

used in combination with it when planning, performing and documenting the qualification process of Infrared

(IR) spectrophotometers.

th

本文件为核心文件“仪器确认”附录4，在规划、执行和记录红外（IR）光谱仪确认过程时应与其联合使用。

The core document contains the Introduction and general forms for Levels I (Selection of instruments and

suppliers) and II (Installation and release for use) of qualification, which are common to all types of

instruments.

核心文件包括了确认第一级（仪器和供应商的选择）和第二级（安装与放行使用）的介绍与常用表格，通用于

所有类型仪器。

The present Annex 4 contains a general introduction and requirements for IR spectrophotometers. Level III

(Periodic and motivated instrument calibration/checks) and IV (In-use instrument checks) qualifications must

be carried out as an ISO 17025 requirement.

附录4中包括红外光谱仪的一般介绍与要求。第三级（定期和有因仪器校正/检查）和第四级（在用仪器检查）

确认必须按ISO 17025要求执行。

Requirements and (if applicable) corresponding typical acceptance limits given in bold should be applied;

however other appropriately justified approaches are acceptable.

应使用加粗显示的要求和相应典型可接受限度（适用时），如有其它经过适当论证的方法时可替代。

Exemplary procedures provided in this document have non-binding character. They can be helpful when

carrying out the required qualification. Nevertheless, it is left to the professional judgement and background

experience of each OMCL to decide on the most relevant procedures to be undertaken in order to

provide evidence that their IR spectrophotometers are working properly and are suitable for their intended

use.

在本文件中给出的说明性程序是非强制的。它们可能对执行所要求确认有所帮助。但是要由每个OMCL根据自

己的专业判断和背景经验来决定要采用的最有关联的程序，以提供证据证明其红外光谱仪能正确工作，适合其

既定用途。

If the qualification of equipment is done by the manufacturer or an external service provider, it is the

responsibility of the OMCL to make sure that this is in line with the requirements set out in this guideline.

如果由生产商或外部服务提供者执行仪器确认，则OMCL有义务确保其符合本指南中所设定的要求。

PA/PH/OMCL (18) 24 R1 – 仪器确认 –红外光谱仪确认 201909 翻译：JULIA 页 2 / 6