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EN ISO 80601-2-12:2011/AC:2011

(Corrigendum)

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)

IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.

Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2011/Cor 1:2011)

Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs - Rectificatif technique 1 (ISO 80601-2-12:2011/Cor 1:2011)

Elektromedicinska oprema - 2-12. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego - Tehnični popravek (ISO 80601-2-12:2011/Cor 1:2011)

IEC 60601-1:2005, točka 1 velja, razen: Podtočka 1.1. 60601-1:2005, točka 1 je nadomeščena z naslednjim. Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI VENTILATORJEV skupaj z DODATKI, v nadaljevanju OPREMA ME: - namenjeno, da jo spremlja strokovni OPERATER pri tistih BOLNIKIH, ki so odvisni od mehanske ventilacije; in OPOMBA 1: Taki VENTILATORJI se štejejo za OPREMO ME ALI SISTEME ME, KI VZDRŽUJEJO TELESNE FUNKCIJE. - namenjeno za uporabo v okoljih za kritično nego v strokovni zdravstveni ustanovi ali namenjeno uporabi pri prevozu v strokovni zdravstveni ustanovi.

General Information

Status
Withdrawn
Publication Date
14-Oct-2011
Withdrawal Date
10-Mar-2020
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
11-Mar-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
SIST EN ISO 80601-2-12:2011/AC:2012 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)

Relations

Replaced By
EN ISO 80601-2-12:2020 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
Effective Date
24-Mar-2020
Corrects
EN ISO 80601-2-12:2011 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
Effective Date
08-Jun-2022

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EN ISO 80601-2-12:2011/AC:2012EN ISO 80601-2-12:2011/AC:2012
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2011/Cor 1:2011)Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs - Rectificatif technique 1 (ISO 80601-2-12:2011/Cor 1:2011)Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 80601-2-12:2011/AC:2011SIST EN ISO 80601-2-12:2011/AC:2012en01-januar-2012SIST EN ISO 80601-2-12:2011/AC:2012SLOVENSKI
STANDARD



SIST EN ISO 80601-2-12:2011/AC:2012



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 80601-2-12:2011/AC
October 2011
Octobre 2011
Oktober 2011 ICS 11.040.10 English version Version Française Deutsche Fassung
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs - Rectificatif technique 1 (ISO 80601-2-12:2011/Cor 1:2011)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2011/Cor 1:2011) This corrigendum becomes effective on 15 October 2011 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 15 octobre 2011 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 15. Oktober 2011 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten. Ref. No.:EN ISO 80601-2-12:2011/AC:2011 D/E/FSIST EN ISO 80601-2-12:2011/AC:2012



EN ISO 80601-2-12:2011/AC:2011 (E) 2 Contents Page Foreword .3 SIST EN ISO 80601-2-12:2011/AC:2012



EN ISO 80601-2-12:2011/AC:2011 (E) 3 Foreword This document (EN ISO 80601-2-12:2011/AC:2011) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. Endorsement notice The text of ISO 80601-2-12:2011/Cor 1:2011 has been approved by CEN as a EN ISO 80601-2-12:2011/AC:2011 without any modification.
SIST EN ISO 80601-2-12:2011/AC:2012



SIST EN ISO 80601-2-12:2011/AC:2012



INTERNATIONAL STANDARD ISO 80601-2-12:2011TECHNICAL CORRIGENDUM 1 Published 2011-10-15 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 
 ORGANISATION INTERNATIONALE DE NORMALISATION
Medical electrical equipment
Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
TECHNICAL CORRIGENDUM 1 Appareils électromédicaux
Partie 2-12:
Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs RECTIFICATIF TECHNIQUE 1 Technical Corrigendum 1 to ISO 80601-2-12:2011 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical equipment.
Page iii to v, Table of contents Between 201.1.1 and 201.108.2, some items contain extra spaces between the second period and the subsequent part of the number. Remove these superfluous spaces. Remove all asterisks from the table of contents.
ICS
11.040.10 Ref. No. ISO 80601-2-12:2011/Cor.1:2011(E)©
ISO 2011 – All rights reserved Published in Switzerland
SIST EN ISO 80601
...

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This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
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