General Information

Abstract

This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard. Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.

Status
Withdrawn
Publication Date
18-Dec-2012
Withdrawal Date
22-Sep-2026
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
28-Sep-2016
Completion Date
23-Sep-2026
Directive
Not Harmonized93/42/EEC - Medical devices

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Corrigendum

EN ISO 5361:2013/AC:2013

English language (2 pages)
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Effective Date
30-Sep-2016
Effective Date
08-Jun-2022

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Corrigendum

EN ISO 5361:2013/AC:2013

English language (2 pages)
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Frequently Asked Questions

EN ISO 5361:2012/AC:2012 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012)". This standard covers: This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard. Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.

This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard. Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.

EN ISO 5361:2012/AC:2012 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 5361:2012/AC:2012 has the following relationships with other standards: It is inter standard links to EN ISO 5361:2016, EN ISO 5361:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 5361:2012/AC:2012 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN ISO 5361:2012/AC:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anästhesie­ und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2012/Cor 1:2012)Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords - Rectificatif technique 1 (ISO 5361:2012/Cor 1:2012)Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012/Cor 1:2012)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 5361:2012/AC:2012SIST EN ISO 5361:2013/AC:2013en01-marec-2013SIST EN ISO 5361:2013/AC:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 5361:2012/AC
December 2012
Décembre 2012
Dezember 2012 ICS 11.040.10 English version Version Française Deutsche Fassung
Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012/Cor 1:2012)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords - Rectificatif technique 1 (ISO 5361:2012/Cor 1:2012)
Anästhesie- und Beatmungsgeräte - Trach
...