SIST EN ISO 20857:2013

Name: SIST EN ISO 20857:2013 — Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
SKU: SIST EN ISO 20857:2013
Price: 127800 RUB
Availability: InStock

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

Название (английский):

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 71
Дата публикации:: 2 августа 2013 г.
ICS:: 11.080.01
Технический комитет:: VAZ - Healthcare

Тип поставки:

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Язык документа:

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Срок поставки:12 раб. дн. (перевод)

Цена:127 800 ₽

Описание (английский):

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

SIST EN ISO 20857:2013 specifies essential requirements for the development, validation, and routine control of dry heat sterilization processes for medical devices. Published by CEN and based on ISO 20857:2010, the standard ensures effective sterilization and depyrogenation in health care products. Dry heat is widely used to eliminate microorganisms and pyrogenic materials-critical for ensuring the safety and efficacy of medical devices. This standard helps manufacturers and health care facilities achieve compliance with regulatory and quality assurance requirements, supporting the delivery of sterile products to the market.

Key Topics

Dry Heat Sterilization: Establishes parameters for the reliable inactivation of microorganisms on medical devices using controlled time and temperature.

Depyrogenation Guidance: Addresses requirements and guidance for removal or inactivation of pyrogenic substances (such as endotoxins) using dry heat, especially where more stringent conditions are needed.

Validation and Control: Details the processes for validating dry heat sterilization methods and ensuring that ongoing production consistently meets established sterility requirements.

Quality Management Elements: Integrates key quality management system aspects relevant to sterilization processes, referencing ISO 13485 for broader quality control.

Documentation and Traceability: Emphasizes the importance of maintaining rigorous documentation for process development, qualification, and routine monitoring.

Process Equipment Requirements: Outlines the need for properly characterized and calibrated equipment, as well as ongoing monitoring and preventive maintenance to safeguard process effectiveness.

Regulatory Compliance: Provides means of demonstrating conformity to applicable EU directives for active implantable devices, medical devices, and in vitro diagnostic devices.

Applications

SIST EN ISO 20857:2013 has practical applications for a variety of stakeholders in the medical device and health care sectors:

Medical Device Manufacturers: Enables the design, validation, and maintenance of robust dry heat sterilization processes, supporting product sterility and patient safety.

Sterilization Service Providers: Guides the implementation and control of dry heat cycles for batch or continuous sterilization facilities.

Health Care Facilities: Facilitates safe reprocessing of reusable devices in hospitals and clinics, where validated dry heat sterilization is part of infection prevention.

Quality and Regulatory Professionals: Assists with audit preparation and ongoing compliance with ISO requirements and European Directives, ensuring that sterilization processes withstand regulatory scrutiny.

Depyrogenation Needs: Applicable to manufacturers of medical device components and packaging, ensuring products not only achieve sterility but also meet endotoxin limits when required.

Related Standards

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

ISO 11138-1 & ISO 11138-4: Sterilization of health care products - Biological indicators for general and dry heat applications

ISO 11140-1: Chemical indicators - General requirements

ISO 11737-1 & ISO 11737-2: Methods for determining and validating microbiological load and sterility

ISO 11607-1 & ISO 11607-2: Packaging standards for terminally sterilized medical devices

IEC 61010-2-040: Safety requirements for sterilizers and washer-disinfectors

EN 556-1: Requirements for designating medical devices as "sterile" in Europe

SIST EN ISO 20857:2013 is a cornerstone for achieving reliable dry heat sterilization and depyrogenation, forming part of a comprehensive framework for medical device safety and regulatory compliance.

SIST EN ISO 20857:2013

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

ISO 20857:2010

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine c…

SIST EN ISO 13485:2016/A11:2021

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

SIST EN ISO 11138-1:2017

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

SIST EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat st…

SIST EN ISO 11140-1:2015

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

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…

ISO 11607-1:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier sys…