BS EN ISO 11137-2:2015 - Standard for Sterilization of Health Care Products

The BS EN ISO 11137-2:2015 is a vital standard within the healthcare technology sector, providing essential guidelines for the validation and routine control of sterilization processes. This document, which is in alignment with ISO 11137-2:2013, offers a comprehensive framework for the establishment of sterilization standards for medical devices, ensuring the highest levels of patient safety and product efficacy.

Key Features

• Applicability: This standard applies to all types of terminally sterilized medical devices and healthcare products. It is crucial for manufacturers, regulatory bodies, and healthcare facilities that prioritize the efficacy and safety of their sterilization processes.
• Validating Sterilization Methods: The document delves into various sterilization methods, including vaporized hydrogen peroxide, ethylene oxide, and radiation, detailing validation protocols necessary for each method. This ensures stakeholders can confidently implement sterilization processes that meet recognized safety standards.
• Routine Control: BS EN ISO 11137-2:2015 outlines necessary procedures for ongoing monitoring and control of the sterilization process, which is paramount to maintaining compliance and ensuring consistent outcomes.
• Documentation and Quality Assurance: Comprehensive requirements for documentation are provided, emphasizing the need for meticulous record-keeping for audits and product traceability, critical for quality assurance and compliance with regulatory mandates.

Benefits of Compliance

By adhering to the BS EN ISO 11137-2:2015, organizations can expect to enhance their sterilization efficacy, thereby reducing the risks associated with infection and bio-burden. Compliance not only fosters trust among healthcare providers and patients but also aligns organizations with international best practices, which can facilitate market access and regulatory approval across regions.

Who Should Use This Standard?

This standard is indispensable for manufacturers of medical devices, healthcare professionals involved in product sterilization, and regulatory authorities overseeing healthcare product safety. By utilizing BS EN ISO 11137-2:2015, stakeholders can ensure robust quality management systems and maintain high safety standards across their operations.

Accessing the Standard

Professionals interested in acquiring the BS EN ISO 11137-2:2015 can do so through various formats, including PDF and hardcopy versions. Priced at £462.00, this standard is a valuable investment in the compliance and safety of your healthcare products.