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CEN

EN ISO 5361:2012/AC:2012

(Corrigendum)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012)

Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012)

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.

Anästhesie­ und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2012)

Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords - Rectificatif technique 1 (ISO 5361:2012)

Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki - Tehnični popravek 1 (ISO 5361:2012/Cor 1:2012)

Ta mednarodni standard določa bistvene zahteve za učinkovitost in varnost ustnih ter nosnih sapničnih (endotrahealnih) tubusov in priključkov. V ta mednarodni standard so vključeni sapnični tubusi, ki imajo stene ojačane s kovino ali najlonom, sapnični tubusi z rameni, konusni sapnični tubusi in sapnični tubusi s sredstvi za sesanje, nadzorovanje ali dostavo zdravil ali drugih plinov. Vključene so tudi druge vrste sapničnih tubusov za posebno uporabo, ker je trenutno v splošni uporabi veliko specializiranih sapničnih tubusov, pri čemer si vsi delijo podobne bistvene zahteve, ki so podane v tem mednarodnem standardu. Trahiobronhialni (endobronhialni) tubusi, traheotomični tubusi in supralaringealne zračne poti so izključene iz področja uporabe tega mednarodnega standarda. Sapnični tubusi, ki so namenjeni uporabi z vnetljivimi anestetičnimi plini ali anestetiki, ter laserska ali elektrokirurška oprema ne spadajo na področje uporabe tega mednarodnega standarda.

General Information

Status
Withdrawn
Publication Date
18-Dec-2012
Withdrawal Date
27-Sep-2016
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
28-Sep-2016
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
SIST EN ISO 5361:2013/AC:2013 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Technical Corrigendum 1 (ISO 5361:2012/Cor 1:2012)

Relations

Replaced By
EN ISO 5361:2016 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Effective Date
30-Sep-2016
Corrects
EN ISO 5361:2012 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
Effective Date
08-Jun-2022

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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
...

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