Подготовка к публикации
ISO 11137-1
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Ссылочный номер
ISO 11137-1
Версия 2
2025-03
© ISO 2025
Подготовка к публикации
Подготовка к публикации (Версия 2, 2025)
Данный международный стандарт находится на заключительных этапах публикации (будет доступен примерно через семь недель).
Текущее издание: ISO 11137-1:2006

What is ISO 11137-1?

ISO 11137-1 specifies requirements for the sterilization of health care products, particularly those involving radiation processes. It provides comprehensive guidelines on how to achieve sterilization and ensure the reliability and effectiveness of the process. This standard is crucial for manufacturers and health care providers who use radiation to sterilize medical devices.

Why is ISO 11137-1 important?

ISO 11137-1 is important as it ensures that medical devices are free from viable microorganisms, which is critical for patient safety. The standard describes how to minimize the microbial presence on devices before sterilization and outlines the methods to validate and control the sterilization process. By doing so, it helps manufacturers provide products that are safe for patient use, meeting both regulatory and clinical expectations.

Benefits

  • Enhanced safety: Ensures the sterility of medical devices, reducing the risk of infections associated with their use
  • Compliance with regulations: Helps manufacturers meet global regulatory requirements for medical device sterilization
  • Improved process efficiency: Provides detailed guidelines for validating and monitoring sterilization processes, enhancing overall efficiency and effectiveness
  • Support for technological advancement: Reflects and incorporates the latest developments in sterilization technology, supporting innovation in medical device manufacturing

FAQ

Manufacturers of medical devices, microbiologists, quality assurance professionals, and regulatory bodies involved in the sterilization of health care products.

The most recent edition of ISO 11137-1 includes several significant changes:

  • Addition of New Normative References: Incorporates ISO 13004 and ISO/ASTM 52628 to align with the latest dosimetry practices and terminology.
  • Updated Clause Structure: Revisions in Clause 4 to better align with ISO/TC 198 documents, enhancing the clarity and application of the standard.
  • Increased Limits for Induced Radioactivity: Updates on allowable limits for electron and X-ray induced radioactivity, reflecting new scientific evidence and technological advancements.
  • Enhanced Control Functions: New requirements to prevent control failures during the sterilization process, ensuring the integrity of process parameter recording.
  • Simplified Content on Dose Verification: Streamlining the transference of verification or sterilization doses based on new data, improving operational efficiency.

ISO 11137-1 is part of the ISO 11137 series, which covers various aspects of radiation sterilization, providing a comprehensive framework when used alongside related standards such as ISO 11137-2 and ISO 13004.

ISO 11137-1 is applicable to medical devices that require sterilization by radiation. It does not cover medical devices requiring other forms of sterilization, which are addressed by other specific standards.

Общая информация

  • Текущий статус
     : В стадии разработки
    Дата публикации
     : 2025-03
    Этап
    : Подготовка международного стандарта к публикации [60.00]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS обновления

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.080
  7. 11.080.01
  8. ISO 11137-1