2024年4月28日发(作者：)
OMCL设备确认附录7：质谱确认
作者：JULIA 来源：Julia法规翻译
PA/PH/OMCL (10) 86 R6 –OMCL设备确认附录7：质谱确
认 201804 生效日期20180801
前版本：PA/PH/OMCL(10)86 2R 201107
ANNEX 7 OF THE OMCL NETWORKGUIDELINE
“QUALIFICATION OF EQUIPMENT”
QUALIFICATION OF MASSSPECTROMETERS
设备确认附录7：质谱仪的确认
Note: Mandatory requirements in this guideline and
its annexes are defined using the terms «shall» or
«must».The use of «should» indicates are
commendation. For these parts of the text other
appropriately justified approaches are term
«can» indicates a possibility or an example with non-binding
character.
注：本指南及其附录中的强制要求采用术语“应”或“必须”进
行定义。使用“应”表示是建议，其下所列要求可采用经过适当论证
的其它方法来实施。术语“可”表示一种可能性，或非强制特性举例。
Introduction 介绍
The present document is the 7
th
Annex of the core document
“Qualification of Equipment” and it shall be used
incombination with it when planning, performing and
documenting the qualificationprocess of Mass Spectrometers
coupled with Chromatographic equipment.
本文件是核心文件“仪器确认”的第7个附件，在规划、实施和
记录质谱确认过程中，应与核心文件结合使用。
The core document “Qualification ofEquipment” contains
the introduction and general forms for Level I and II
ofqualification, which are common to all type of instruments.
核心文件“设备确认”包括了介绍和适用于所有类型仪器的第一
级和第二级确认用通用表格。
The present Annex 7 contains a generalintroduction and
requirements for GC-EI-MS and LC-ESI-MS. Level III and
IVqualifications must be carried out being an ISO 17025
requirement.
本附录7包括与GC-EI-MS和LC-ESI-MS有关的通用介绍和要求。
必须执行第三级和第四级确认是ISO17025的要求。
Requirements and (if applicable)corresponding typical
acceptance limits given in bold should be applied,however other
appropriately justified deviations are acceptable provided
theyare traceable.
应采用加粗的要求及（适用时）相应的典型可接受限度，但只要
可以追溯，也可以接受其它经过适当论证的偏差。
Exemplary procedures provided in Annexeshave non-
binding character. They can be helpful to carry out the
requiredqualification. Nevertheless, other procedures can be
applied depending on the modelof the MS equipment.
在附录中给出的示范程序并非强制，它可能有助于执行所需的确
认。但根据MS设备的型号不同，也可采用其它程序。
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