SIST EN ISO 25424:2020/A1:2022 PDF

Name: SIST EN ISO 25424:2020/A1:2022 — Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
SKU: SIST EN ISO 25424:2020/A1:2022
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Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

Название (английский):

SIST EN ISO 25424:2020/A1:2022

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 15
Дата публикации:: 16 июня 2022 г.
ICS:: 11.080.01
Технический комитет:: VAZ - Healthcare

Тип поставки:

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Язык документа:

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Срок поставки:3 раб. дн. (перевод)

Цена:225 €

Описание (английский):

2022-01-13 - TC decision is missing to skip FV - publication on hold.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 25424:2019/A1:2022 is the CEN-endorsed amendment to ISO 25424, addressing sterilization of health care products using low temperature steam and formaldehyde. The amendment updates requirements for the development, validation and routine control of sterilization processes for medical devices. It clarifies the scope of application, links to EU medical device regulations, and references key microbiological, biological and chemical indicator standards used in process qualification and routine monitoring.

Note: users should confirm the current publication/endorsement status with their national standards body or the CEN website.

Key topics and technical requirements

Process development and validation: requirements for designing and validating a low-temperature steam/formaldehyde sterilization cycle so that treated devices are safe and perform as intended after sterilization.

Routine control and monitoring: expectations for cycle monitoring, use of biological and chemical indicators, and ongoing control to demonstrate continued process performance.

Microbiological considerations: alignment with microbiological methods and sterility test principles (references include ISO 11737‑1 and ISO 11737‑2) for establishing microbial load and sterility test protocols.

Indicators and acceptance criteria: normative linkage to biological indicator standards (ISO 11138 parts) and chemical indicators (ISO 11140‑1) for process qualification and routine checks.

Regulatory alignment and risk management: annexes explain how the standard supports conformity to EU Regulations 2017/745 (medical devices) and 2017/746 (IVDs). Risk management references must be consistent with those Regulations.

Limitations: the standard focuses on attainment of a specific microbial state by low temperature steam and formaldehyde; it does not cover device packaging design for maintenance of sterility during transport/storage or unrelated manufacturing aspects.

Applications and who uses it

Medical device manufacturers performing sterilization process development and validation for devices sensitive to higher‑temperature methods.

Sterile processing departments, contract sterilization service providers and validation engineers setting up or auditing low‑temperature steam & formaldehyde cycles.

Quality assurance, regulatory affairs and compliance teams demonstrating conformity with EU General Safety and Performance Requirements.

Test laboratories and indicator manufacturers implementing and interpreting biological and chemical indicator results for process qualification.

Related standards (normative references)

ISO 11138‑1, ISO 11138‑5 - Biological indicators

ISO 11140‑1 - Chemical indicators

ISO 11737‑1, ISO 11737‑2 - Microbiological methods and sterility testing

EN ISO 25424:2019/A1:2022 is essential guidance for stakeholders involved in validation and routine control of low‑temperature steam/formaldehyde sterilization, helping ensure safe, reproducible sterilization of temperature‑sensitive medical devices.

SIST EN ISO 25424:2020/A1:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards (normative references)

Технические детали

ISO 25424:2018/Amd 1:2022

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development…

ISO 11737-1:2018/Amd 1:2021

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of mi…

SIST EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the…

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)

SIST EN ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:201…

SIST EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-tempera…