EN 12439:1998

Sterile rectal catheters for single use

This European Standard specifies requirements for single-use rectal catheters intended to be inserted into the rectum of a patient, for emptying, rinsing or filling purposes.

Sterile Rektalkatheter zur einmaligen Verwendung

Diese Europäische Norm legt Anforderungen an Rektalkatheter zur einmaligen Verwendung fest. Sie sind dazu bestimmt, transanal in den Darm des Patienten eingeführt zu werden, um diesen zu entleeren, zu spülen oder zu füllen.

Sondes rectales stériles non réutilisables

La présente norme européenne spécifie les exigences relatives aux sondes rectales non réutilisables destinées à être introduites dans le rectum du patient, aux fins de purge, de rinçage ou de remplissage.

Sterilni rektalni katetri za enkratno uporabo

General Information

• Status: Published
• Publication Date: 20-Oct-1998
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 6 - Catheters and enteral feeding tubes
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 05-Jun-2023
• Completion Date: 11-Feb-2026
• Ref Project: SIST EN 12439:2000 - Sterile rectal catheters for single use

Relations

• Refers: EN ISO 20695:2020 - Enteral feeding systems - Design and testing (ISO 20695:2020)
• Effective Date: 28-Jan-2026
• Refers: EN ISO 20417:2021 - Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
• Effective Date: 28-Jan-2026
• Refers: EN 556:1994 + A1:1998 - Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
• Effective Date: 28-Jan-2026

Overview

EN 12439:1998 is a European Standard developed by CEN that specifies the requirements for sterile rectal catheters intended for single use. These medical devices are designed to be inserted into the rectum of patients for procedures such as emptying, rinsing, or filling. The standard ensures that rectal catheters used in healthcare settings meet strict safety, hygiene, and performance criteria, minimizing the risk of infection and cross-contamination.

Healthcare professionals and medical device manufacturers rely on EN 12439:1998 to guarantee product quality and compliance with European regulatory requirements.

Key Topics

• Sterility Requirements

  • Mandates that rectal catheters are sterile at the point of use to prevent patient infection.
  • Outlines proper sterilization processes and packaging standards.

• Single-Use Design

  • Specifies that each rectal catheter is intended for one patient procedure only, eliminating reuse risks.
  • Details labeling and instructions to emphasize single-use compliance.

• Material and Construction

  • Sets criteria for materials used in manufacturing rectal catheters to ensure biocompatibility and patient safety.
  • Addresses catheter flexibility, strength, and smoothness to minimize patient discomfort and ensure effective use.

• Performance Requirements

  • Ensures catheters fulfill intended clinical functions for emptying, rinsing, or filling the rectum safely and efficiently.
  • Covers compatibility with various fluids and resistance to breakage.

• Instructions and Labeling

  • Requires clear, easily understandable product labeling, including usage instructions and disposal guidelines.
  • Emphasizes the importance of proper product identification to avoid misuse or accidental reuse.

Applications

EN 12439:1998 applies to a range of healthcare environments where sterile, single-use rectal catheters are essential:

• Hospitals and Clinics
  • Used during intestinal procedures, diagnostic tests, bowel management, and administration of medication or contrast agents.
• Care Homes and Outpatient Settings
  • Provides a hygienic solution for patient care while reducing the risks associated with reusable equipment.
• Medical Device Manufacturing
  • Offers guidance for producing compliant, high-quality rectal catheters that meet European healthcare standards.
• Infection Control
  • Plays a vital role in hospital infection prevention protocols by ensuring single-use, sterile equipment.

Healthcare facilities incorporating EN 12439:1998-compliant products enhance patient safety and meet regulatory requirements for medical devices.

Related Standards

For comprehensive compliance and quality assurance, EN 12439:1998 should be referenced alongside other relevant standards, such as:

• ISO 13485 - Quality management systems for medical devices
• EN ISO 11135 - Sterilization of health care products - Ethylene oxide
• EN ISO 10993 - Biological evaluation of medical devices
• EN ISO 15223-1 - Medical device labeling requirements
• EN 556-1 - Requirements for labeling of sterile medical devices

By adhering to EN 12439:1998 and associated standards, organizations can ensure that sterile rectal catheters for single use are safe, effective, and compliant for use across Europe's healthcare sector.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilni rektalni katetri za enkratno uporaboSterile Rektalkatheter zur einmaligen VerwendungSondes rectales stériles non réutilisablesSterile rectal catheters for single use11.040.25Injekcijske brizge, igle in katetriSy
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