EN ISO 11135:2014/A1:2019 PDF

Name: EN ISO 11135:2014/A1:2019 — Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Название (английский):

EN ISO 11135:2014/A1:2019

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 22
Дата публикации:: 20 ноября 2019 г.
Издание:: CEN EN 11135 edition 1 version 1
ICS:: 11.080.01

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Описание (английский):

20191119 - Negative assessment addressed through BT decision C168/2019 (SV) 2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y. 2018-10-17 - TAN : Lack of compliance

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 11135:2014/A1:2019 is the CEN-adopted amendment to ISO 11135:2014 that updates the ethylene oxide (EO) sterilization standard for medical devices. The amendment revises Annex E - Single batch release, and clarifies how EO sterilization processes must be developed, validated and maintained under routine control. The document supports conformity with relevant EU Directives and Regulations (including 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations (EU) 2017/745 and 2017/746) when cited in the Official Journal.

Keywords: EN ISO 11135, ethylene oxide sterilization, medical device sterilization, single batch release, sterilization validation, routine control.

Key topics and technical requirements

Scope and purpose: Requirements for the development, validation and routine control of EO sterilization processes for health‑care products (medical devices). The amendment specifically revises provisions for single batch release in Annex E.

Process development & validation: Framework for establishing a validated EO sterilization cycle that reliably achieves the required sterility assurance level; aligns sterilization validation with risk management.

Routine control & monitoring: Expectations for ongoing process control and release testing to ensure continued compliance once a process is validated.

Single batch release (Annex E): Updated guidance on criteria and controls when releasing individual sterilization batches (single batch release), reflecting risk‑based decision making and documentation needs.

Normative references: The amendment references related ISO standards such as ISO 10993‑7 (EO residuals/biocompatibility), ISO 11138 (biological indicators), ISO 11140‑1 (chemical indicators), ISO 11737 (microbiological methods) and ISO 13485 (quality management), indicating integration with biological indicator use, microbial testing and residual evaluation.

Applications - who uses this standard

Medical device manufacturers developing EO sterilization processes.

Contract sterilization service providers validating and operating EO sterilizers.

Quality assurance and regulatory affairs professionals responsible for sterilization validation and product release.

Validation engineers and microbiologists implementing process qualification and routine monitoring.

Notified bodies and competent authorities assessing conformity and sterilization evidence.

This standard is essential for organizations seeking to demonstrate a controlled, validated EO sterilization process and to support regulatory filings and conformity assessment for EO‑sterilized medical devices.

Related standards

ISO 10993‑7 - Ethylene oxide residuals / biocompatibility

ISO 11138 series - Biological indicators

ISO 11140‑1 - Chemical indicators

ISO 11737 series - Microbiological methods for sterilization

ISO 13485 - Medical device quality management systems

For EO sterilization validation and single batch release guidance, EN ISO 11135:2014/A1:2019 is the primary European reference; consult the cited normative ISO standards for technical test methods and indicator requirements.

EN ISO 11135:2014/A1:2019 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications - who uses this standard

Related standards

Технические детали

ISO 11135:2014

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and rou…

ISO 11135:2014/Amd 1:2018

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and rou…

ISO 10993-7:2008/Amd 1:2019

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Appl…

SIST EN ISO 11138-8:2021

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced in…

SIST EN ISO 11140-1:2015

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

BS ISO 11737-3:2023

Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing.

SIST EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)