BS EN ISO 13408-1-2024 医疗产品的无菌加工第 1 部分：通用要求

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BSI Standards Publication
Aseptic processing of health care products
Part 1: General requirements
BS EN ISO 13408‑1:2024
National foreword
This British Standard is the UK implementation of
EN ISO 13408‑1:2024. It is identical to ISO 13408‑1:2023. It supersedes
BS EN ISO 13408‑1:2015, which is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CH/198, Sterilization and Associated Equipment
and Processes.
A list of organizations represented on this committee can be obtained on
request to its committee manager.
Contractual and legal considerations
This publication has been prepared in good faith, however no
representation, warranty, assurance or undertaking (express or
implied) is or will be made, and no responsibility or liability is or will be
accepted by BSI in relation to the adequacy, accuracy, completeness or
reasonableness of this publication. All and any such responsibility and
liability is expressly disclaimed to the full extent permitted by the law.
This publication is provided as is, and is to be used at the
recipient’s own risk.
The recipient is advised to consider seeking professional guidance with
respect to its use of this publication.
This publication is not intended to constitute a contract. Users are
responsible for its correct application.
This publication has been prepared under a mandate given to the
European Standards Organizations by the European Commission and the
European Free Trade Association. It is intended to support requirements
of the EU legislation detailed in the European Foreword. A European
Annex, usually Annex ZA or ZZ, describes how this publication relates to
that EU legislation.
For the Great Britain market (England, Scotland and Wales), if UK
Government has designated this publication for conformity with UKCA
marking (or similar) legislation, it may contain an additional National
Annex. Where such a National Annex exists, it shows the correlation
between this publication and the relevant UK legislation. If there is no
National Annex of this kind, the relevant Annex ZA or ZZ in the body
of the European text will indicate the relationship to UK regulation
applicable in Great Britain. References to EU legislation may need to be
read in accordance with the UK designation and the applicable UK law.
Further information on designated standards can be found at
www.bsigroup.com/standardsandregulation.
For the Northern Ireland market, UK law will continue to implement

Annex ZA/ZZ in the European text, and references to EU legislation, are
still valid for this market.
UK Government is responsible for legislation. For information on
legislation and policies relating to that legislation, consult the relevant
pages of www.gov.uk.
© The British Standards Institution 2024
Published by BSI Standards Limited 2024
BRITISH STANDARD
BS EN ISO 13408‑1:2024
ISBN 978 0 539 03092 1
ICS 11.080.01
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 April 2024.
Amendments/corrigenda issued since publication
Date Text affected
BRITISH STANDARD BS EN ISO 13408‑1:2024

标签： #ISO #通用要求

摘要：

本页面详细介绍 BS EN ISO 13408-1-2024 标准，即医疗产品无菌加工系列标准的第一部分——通用要求。该标准由国际标准化组织（ISO）制定，并于2024年更新发布，适用于医疗产品、药品及生物制品的无菌生产工艺。内容涵盖无菌加工的环境控制、人员培训、设备验证、过程模拟、灭菌方法及质量监控等核心要求。无论您是制药企业、医疗器械制造商，还是从事无菌生产合规与质量管理的专业人员，通过本页可全面了解该标准的最新修订要点、适用范围及实施指南，助力您的产品满足国际无菌加工规范要求，确保生产安全

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作者：乔大爷开音响 分类：国际标准 价格：20星币 属性：94 页 大小：3.14MB 格式：PDF 时间：2025-05-08

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