SIST EN ISO 80369-3:2016/oprA1:2017

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/DAmd 1:2017)

2017-06-16: Project merged in ISO/CS - New WI JT003050

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen (ISO 80369-3:2016/DAmd 1:2017)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-3:2016/DAmd 1:2017)

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/DAmd 1:2017)

General Information

• Status: Not Published
• Public Enquiry End Date: 14-May-2017
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 18-Nov-2020
• Due Date: 23-Nov-2020
• Completion Date: 18-Nov-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1

Relations

• Amends: SIST EN ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
• Effective Date: 01-May-2017

Overview

SIST EN ISO 80369-3:2016/oprA1:2017 is an amendment to the international standard specifying small-bore connectors for enteral applications used in healthcare. Developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN), this standard focuses on improving safety and compatibility in medical devices involving the administration of liquids and gases via enteral routes.

Small-bore connectors are critical components in healthcare, designed to connect medical tubing and devices while minimizing risks of misconnections and contamination. This amendment, also known as Amendment 1 to ISO 80369-3:2016, updates the scope and requirements, especially by revising exclusion criteria related to rectal devices.

Key Topics

• Small-Bore Connectors for Enteral Applications: Defines dimensions, performance, and safety criteria for connectors intended for enteral feeding and fluid delivery.
• Amendment 1 Scope Update: Removes exclusion of certain rectal devices from the standard, broadening the applicability to connectors used in rectal drainage and medication administration.
• Connector Safety: Emphasizes preventing misconnections with other medical device systems (e.g., intravenous or respiratory systems), thereby enhancing patient safety.
• Standardization Process: Developed under ISO/TC 210 and IEC/SC 62D collaboration, following ISO/IEC Directives to maintain rigor in technical content and editorial quality.
• Patent Considerations: Alerts stakeholders to potential patent rights impacting the connector designs, ensuring transparency for manufacturers and users.

Applications

The standard is vital for medical device manufacturers, healthcare providers, and regulatory bodies focused on enteral therapy. Typical applications include:

• Enteral Feeding Systems: Ensuring reliable and safe connections between feeding tubes and nutrient delivery equipment.
• Medication Administration: Safe administration of drugs through enteral routes without risk of cross-connection errors.
• Fluid Delivery via Enteral Routes: Connecting devices for hydration or other liquid therapy in clinical settings.
• Rectal Medical Devices: Post-amendment inclusion of rectal drainage and administration devices, expanding the range of covered applications and promoting consistent safety standards.

Implementing SIST EN ISO 80369-3:2016/oprA1:2017 supports risk reduction in healthcare by standardizing connector designs to avoid potentially harmful misconnections between different delivery systems.

Related Standards

• ISO 80369 Series: The broader series of standards addressing small-bore connectors for various medical uses, including:

  • Part 1: General requirements
  • Part 2: Connectors for breathing systems and driving gases
  • Part 5: Connectors for limb cuff inflation
  • Part 6: Connectors for neuraxial applications
  • Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
  • Part 20: Common test methods

• ISO/IEC Directives: Framework documents that guide development and maintenance of ISO and IEC standards, ensuring consistency and quality internationally.

• IEC/SC 62D: The subcommittee responsible for electromechanical medical equipment, collaborating in the technical development of connector standards relevant to patient safety.

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By adhering to SIST EN ISO 80369-3:2016/oprA1:2017, healthcare stakeholders ensure safe, interoperable, and reliable connectors for enteral applications, enhancing patient safety and compliance with international regulatory requirements. This amendment reflects ongoing efforts to expand the scope and clarity of connector standards in medical device technology.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2017
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DHQWHUDOQRXSRUDER'RSROQLOR$,62'$PG
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/DAmd 1:2017)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen
(ISO 80369-3:2016/DAmd 1:2017)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/DAmd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/prA1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT AMENDMENT
ISO 80369-3:2016/DAM 1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-02-24 2017-05-18
Small-bore connectors for liquids and gases in healthcare
applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1: .
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1: .
ICS: 11.040.25
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 80369-3:2016/DAM 1:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017

ISO 80369-3:2016/DAM 1:2017(E)

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