ISO 11135:2014

Name: ISO 11135:2014 — Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
SKU: ISO 11135:2014
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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

Название (английский):

ISO 11135:2014

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 78
Дата публикации:: 7 июля 2014 г.
Издание:: ISO IS 11135 edition 2 version 1
ICS:: 11.080.01

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Описание (английский):

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11135:2014 - Sterilization of health‑care products - Ethylene oxide specifies the requirements for the development, validation and routine control of an ethylene oxide (EO) sterilization process for medical devices. It covers both industrial and health‑care facility settings and recognises their similarities and differences. The standard describes a structured program - from sterilizing‑agent characterization through equipment and process qualification to routine monitoring and product release - intended to provide a high degree of confidence in achieving sterile medical products.

Key topics and technical requirements

ISO 11135:2014 focuses on practical, auditable requirements (normative) and supporting guidance (informative annexes). Major technical topics include:

Sterilizing agent characterization

EO properties, microbicidal effectiveness, material interactions, and safety/environmental considerations.

Process and equipment characterization

Definition of process parameters and mapping of equipment performance and limitations.

Product definition and microbiological considerations

Product physical and microbiological attributes that affect sterilization outcomes.

Process definition and validation

Validation lifecycle: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Validation approaches described in Annex A (biological indicator/bioburden), Annex B (overkill), and guidance in Annex D.

Routine monitoring, control and product release

Ongoing process control, documentation, and criteria for releasing sterilized lots (including Annex E on single lot release).

Maintaining process effectiveness

Equipment maintenance, requalification, change control and equivalence assessment.

Measurement, documentation and quality management

Integration with quality systems, documentation, and control of nonconforming product.

Practical applications and who uses it

ISO 11135:2014 is used by:

Medical device manufacturers designing EO sterilization processes for new or existing devices.

Contract sterilization service providers and industrial sterilizers operating EO chambers.

Hospital sterile processing departments and health‑care facilities reprocessing reusable medical devices in accordance with manufacturer instructions.

Regulatory and quality assurance professionals developing validation protocols, batch release criteria and change control procedures.

Engineers and microbiologists performing IQ/OQ/PQ studies, biological indicator testing and routine process monitoring.

Practical benefits include consistent validation methodology, reduced regulatory risk, and improved patient safety through controlled EO exposure and residue considerations.

Related standards

ISO 13485 - Quality management for medical devices

ISO 9001 - Quality management systems

ISO 10993‑7 - Biological evaluation (EO and by‑products)

EN 556‑1 and ANSI/AAMI ST67 - Sterility assurance/sterilization requirements

Keywords: ISO 11135:2014, ethylene oxide sterilization, EO sterilization, medical device sterilization, sterilization validation, IQ OQ PQ, routine monitoring, sterilization process.

ISO 11135:2014

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses it

Related standards

Технические детали

ISO 14969:1999

Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488

ISO/TS 54001:2019

Quality management systems — Particular requirements for the application of ISO 9001:2015 for electoral organ…

BS EN ISO 10993-7:2026

Biological evaluation of medical devices. Ethylene oxide sterilization residuals.