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IEC 60601-1-11:2015

(Main)

Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.

Appareils électromédicaux — Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

L'IEC 60601-1-11:2015 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, destinés à être utilisés dans l'environnement des soins à domicile. Elle s'applique sans distinguer si l'appareil électromédical ou le système électromédical est prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. L'environnement des soins à domicile comprend: - l'habitation dans laquelle un patient vit; - d'autres environnements où des patients sont présents à l'intérieur comme à l'extérieur, à l'exclusion des environnements des établissements de soins où des opérateurs ayant une formation médicale sont disponibles de façon continue lorsque des patients sont présents. Cette deuxième édition annule et remplace la première édition de l'IEC 60601-1-11, parue en 2010. Cette édition constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes: - correction de la méthode d'essai pour le contrôle de l'humidité relative à des températures supérieures à 35 °C; - reformulation des paragraphes qui modifient plus qu'ils ne complètent la norme générale ou d'autres normes collatérales; et - harmonisation avec les modifications apportées aux amendements de la norme générale et aux autres normes collatérales.

General Information

Status
Published
Publication Date
20-Jan-2015
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
Drafting Committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
Current Stage
9020 - International Standard under periodical review
Start Date
15-Jul-2025
Completion Date
15-Jul-2025
Ref Project

Relations

Amended By
IEC 60601-1-11:2015/Amd 1:2020 - Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment — Amendment 1
Effective Date
11-Dec-2021
Revises
IEC 60601-1-11:2010/Cor 1:2011 - Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment — Technical Corrigendum 1
Effective Date
14-Dec-2013
Revises
IEC 60601-1-11:2010 - Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Effective Date
14-Dec-2013

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IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment

Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
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IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1-11: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment

Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances

essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux

et les systèmes électromédicaux utilisés dans l’environnement des soins à

domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2180-8

– 2 – IEC 60601-1-11:2015 © IEC 2015
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 12
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and
ME SYSTEMS . 12
4.2 * Environmental conditions for ME EQUIPMENT . 12
4.2.1 General . 12
4.2.2 * Environmental conditions of transport and storage between uses . 13
4.2.3 * Environmental operating conditions . 14
5 * General requirements for testing ME EQUIPMENT . 16
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 17
7 ME EQUIPMENT identification, marking and documents . 17
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 17
7.2 * Additional requirements for marking of IP classification . 18
7.3 ACCOMPANYING DOCUMENTS . 18
7.3.1 Contact information . 18
7.3.2 LAY OPERATOR briefing information . 18
7.4 Instructions for use . 19
7.4.1 Additional requirements for warning and safety notices . 19
7.4.2 * Additional requirements for an electrical power source . 19
7.4.3 Additional requirements for ME EQUIPMENT description . 20
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 20
7.4.5 Additional requirements for operating instructions . 20
7.4.6 Additional requirements for ME EQUIPMENT messages . 21
7.4.7 * Additional requirements for cleaning, disinfection and sterilization . 21
7.4.8 Additional requirements for maintenance . 21
7.4.9 Additional requirements for environmental protection . 21
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS . 22
7.5 Technical description . 22
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 22
7.5.2 Additional requirements for professional hygienic maintenance . 22
8 Protection against excessive temperatures and other HAZARDS . 22
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS . 22
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS. 23
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 23
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT . 23

8.3.2 * Ingress of water or particulate matter into ME SYSTEMS . 23
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM . 23
8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 24
8.5.1 * Indication of state . 24
8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 25
9 Accuracy of controls and instruments and protection against hazardous outputs . 25
10 Construction of ME EQUIPMENT . 25
10.1 * Additional requirements for mechanical strength . 25
10.1.1 General requirements for mechanical strength . 25
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT . 27
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT . 28
10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 29
11 * Protection against strangulation or asphyxiation . 30
12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and
ME SYSTEMS . 30
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 30
13.1 * Additional requirement for generation of ALARM SIGNALS . 30
13.2 * Additional requirement for ALARM SIGNAL volume . 30
Annex A (informative) General guidance and rationale . 31
A.1 General guidance . 31
A.2 Rationale for particular clauses and subclauses . 32
A
...

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ISO 18562-1:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

This document specifies: — the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments; — the general categorization of gas pathways based on the nature and duration of their contact with the gas stream; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the gas pathway; — the assessment of the biological safety of the gas pathway. This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage. The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances. This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient. This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use). This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).

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ISO
ISO 80601-2-84:2023(Main)
Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13. ¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80. ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾ user-powered resuscitators, which are given in ISO 10651‐4. ¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾ high‐frequency oscillatory ventilators (HFOVs) REF _Ref69393406 \r \h \* MERGEFORMAT [44] 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F00520065006600360039003300390033003400300036000000 , which are given in ISO 80601-2-87. NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾ oxygen therapy constant flow ME equipment. ¾ cuirass or “iron‐lung” ventilators.

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ISO
ISO 80601-2-12:2023(Main)
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

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: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾ intended to be operated by a healthcare professional operator; and ¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high-frequency ventilators, which are given in ISO 80601‑2‑87; NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90; NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing p

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ISO
ISO 80601-2-72:2023(Main)
Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

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