ISO 11135-2014 amd1-2018 PDF

Full title and description

ISO 11135:2014/Amd 1:2018 — 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). This document is an amendment to ISO 11135:2014 that revises the requirements and guidance contained in Annex E regarding single-batch release of EO-sterilized medical devices.

Abstract

This amendment updates Annex E of ISO 11135:2014 to clarify and revise criteria and procedures for single-batch release following ethylene oxide sterilization. It is intended to be used alongside the main ISO 11135:2014 text, which defines requirements for development, validation and routine control of ethylene oxide sterilization processes in both industrial and health-care facility settings.

General information

• Status: Published (International Standard — Amendment).
• Publication date: October 2018 (published 15 October 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 — Sterilization and disinfection in general.
• Edition / version: Amendment 1 to ISO 11135:2014 (Edition 2) — ISO 11135:2014/Amd 1:2018.
• Number of pages: 4 (amendment document).

Core bibliographic and status details taken from the ISO bibliographic entries for ISO 11135:2014 and its Amendment 1 (2018).

Scope

The amendment specifically revises Annex E (Single batch release) of ISO 11135:2014. It applies where single-batch release procedures are used for ethylene oxide sterilized medical devices and clarifies the conditions, documentation and decision criteria necessary to permit release of a single sterilization batch. The amendment is intended to be read and applied together with the full ISO 11135:2014 standard, which covers development, validation and routine control of EO sterilization processes for medical devices in industrial and health-care facility settings.

Key topics and requirements

• Revision and clarification of Annex E: single-batch release criteria and procedural requirements.
• Requirements for documentation supporting single-batch release decisions (records, test results, deviations and corrective actions).
• Criteria related to bioburden, process parameters, exposure and aeration that inform release decisions for EO sterilization.
• How single-batch release interacts with validated routine control and periodic revalidation requirements.
• Emphasis on traceability, responsibility for release decisions and conformity with the full ISO 11135 validation framework.

These topics reflect the amendment focus (Annex E) and the broader requirements of ISO 11135:2014 for EO sterilization process development, validation and control.

Typical use and users

Applicable users include medical device manufacturers, sterilization service providers, quality and regulatory affairs professionals, sterilization engineers, and auditing/inspection bodies who operate or oversee ethylene oxide sterilization in both industrial and in‑facility contexts. The amendment is relevant where single-batch release procedures are implemented or considered.

Related standards

ISO 11135:2014 (base standard) — the amendment modifies Annex E of this document. Related standards commonly used alongside ISO 11135 include ISO 11137 (radiation sterilization standards), ISO 11607 (packaging for terminally sterilized medical devices) and various national/adopted versions such as EN ISO 11135:2014/A1:2019.

Keywords

Ethylene oxide, EO sterilization, medical devices, sterilization validation, routine control, single-batch release, Annex E, ISO 11135, sterilization process development, bioburden, aeration, release criteria.

FAQ

Q: What is this standard?

A: It is Amendment 1 (2018) to ISO 11135:2014 that revises Annex E (Single batch release) of the ISO 11135 standard for ethylene oxide sterilization of health‑care products.

Q: What does it cover?

A: The amendment clarifies and revises requirements and guidance specifically for single-batch release following EO sterilization; it is used together with ISO 11135:2014, which covers development, validation and routine control of EO sterilization processes.

Q: Who typically uses it?

A: Medical device manufacturers, contract sterilizers, quality/regulatory personnel, sterilization engineers and auditors who need to apply or assess single-batch release practices for EO-sterilized devices.

Q: Is it current or superseded?

A: ISO 11135:2014 remains the base standard with Amendment 1 published in October 2018; ISO lists the 2014 edition with Amendment 1 as published and, as of ISO bibliographic information, the 2014 edition (with its amendment) was reviewed/confirmed in 2024. Users should check national and organizational adoption/versions (for example EN adoption) for any later revisions or replacement drafts.

Q: Is it part of a series?

A: It is part of the ISO documents addressing sterilization of health-care products; ISO 11135 addresses EO sterilization specifically, while related ISO series and documents (for other sterilization modalities and packaging) include ISO 11137 and ISO 11607.

Q: What are the key keywords?

A: Ethylene oxide, single-batch release, sterilization validation, bioburden, aeration, medical devices, ISO 11135, Annex E.