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- Withdrawn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
- 20-Jan-2026
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 11-Mar-2020
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 24-Mar-2020
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 80601-2-12:2011/AC:2011 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "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)". This standard covers: 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.
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.
EN ISO 80601-2-12:2011/AC:2011 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 80601-2-12:2011/AC:2011 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-12:2020, EN ISO 80601-2-12:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-12:2011/AC:2011 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 80601-2-12:2011/AC:2011 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.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
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
INTERNATIONAL STANDARD ISO
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