EN 12439:1998
(Main)Sterile rectal catheters for single use
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
- 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
- 14-Apr-2025
Overview
EN 12439:1998 - Sterile rectal catheters for single use is a European Standard published by CEN that specifies requirements for single‑use rectal catheters intended to be inserted into the rectum of a patient for emptying, rinsing or filling purposes. It applies to sterile, disposable rectal catheters and establishes baseline expectations for safety, hygiene and intended use. The standard is classified under ICS 11.040.25 (syringes, needles and catheters) and has been adopted nationally in some countries (e.g., SIST EN 12439:2000).
Key Topics
EN 12439 sets out requirements and topics typically addressed for single‑use sterile rectal catheters, including:
- Scope and intended use - definition of device types covered (single‑use, rectal insertion for emptying, rinsing, filling).
- Design and materials - requirements to ensure safe insertion and functional performance while minimizing patient risk.
- Sterility and contamination control - provisions on sterility status and measures to prevent microbial contamination during manufacture and packaging.
- Packaging and labelling - information for safe storage, identification of single‑use status, batch/lot traceability and expiry/shelf‑life indications.
- Performance and safety - functional performance criteria and general safety considerations during use.
- Instructions for use (IFU) - required user information for correct, safe application and disposal.
Note: The standard defines requirement areas rather than prescribing a single manufacturing method; manufacturers must meet the specified safety and performance outcomes.
Applications
EN 12439 is practical for:
- Medical device manufacturers designing and producing sterile single‑use rectal catheters to meet European market expectations.
- Quality and regulatory teams ensuring products comply with European standards and facilitating CE marking and national adoption.
- Procurement and clinical teams (hospitals, clinics, nursing, gastroenterology and colorectal care units) selecting devices that meet recognized sterility and safety criteria.
- Infection control and sterile processing teams using the standard as a reference for single‑use policy and risk reduction.
Related Standards
Practitioners commonly use EN 12439 alongside other standards and guidance covering:
- medical device quality management and regulatory conformity,
- sterilization methods and validation, and
- general labelling, packaging and biocompatibility requirements for single‑use devices.
Keywords: EN 12439, sterile rectal catheters, single‑use rectal catheters, CEN standard, rectal catheter sterility, medical device manufacturers, infection control.
Frequently Asked Questions
EN 12439:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterile rectal catheters for single use". This standard covers: 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.
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.
EN 12439:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
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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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