I.S. EN ISO 80601-2-13:2012

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)

Available format(s)

Hardcopy , PDF

Superseded date

17-12-2019

Language(s)

English

Published date

01-01-2012

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
        and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
        HAZARDS
201.11 Protection against excessive temperatures and other
        HAZARDS
201.12 Accuracy of controls and instruments and protection
        against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME
        SYSTEMS
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY
        SYSTEMS
201.102 Additional requirements for an ANAESTHETIC BREATHING
        SYSTEM
201.103 Additional requirements for an ANAESTHETIC GAS
        SCAVENGING SYSTEM
201.104 Additional requirements for an ANAESTHETIC VAPOUR
        DELIVERY SYSTEM
201.105 Additional requirements for an ANAESTHETIC VENTILATOR
        pause
201.106 Display loops
201.107 Clinical evaluation
202 Electromagnetic compatibility - Requirements and tests
203 General requirements for radiation protection in
        diagnostic X-ray equipment
206 Usability
208 General requirements, tests and guidance for ALARM
        SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS
209 Requirements for environmentally conscious design
210 PROCESS requirements for the development of physiologic
        closed-loop controllers
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS used in the home healthcare
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS or their
        parts
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Test for flammability of anaesthetic
         agent
Annex CC (informative) - Environmental aspects
Annex DD (informative) - Reference to the essential principles
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography
Alphabetized index of defined terms used in this particular
standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional OPERATOR.

DevelopmentNote	Supersedes I.S. EN ISO 8835-2, I.S. EN ISO 8835-3, I.S. EN ISO 8835-4, I.S. EN ISO 8835-5 & I.S. EN 60601-2-13. (02/2013)
DocumentType	Standard
Pages	119
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN ISO 80601-2-13:2012/A2:2019 I.S. EN ISO 80601-2-13:2022
Supersedes	I.S. EN ISO 8835-5:2009 I.S. EN ISO 8835-3:2009 I.S. EN ISO 8835-2:2009 I.S. EN ISO 8835-4:2009 I.S. EN 60601-2-13:2006

Standards	Relationship
ISO 80601-2-13:2011	Identical
EN ISO 80601-2-13:2012	Identical

ISO 8836:2014	Suction catheters for use in the respiratory tract
ISO 5360:2016	Anaesthetic vaporizers Agent-specific filling systems
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60083:2015	Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
BS 4272-3:1989	Anaesthetic and analgesic machines Specification for continuous flow anaesthetic machines
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 9170-2:2008	Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
ISO 10651-4:2002	Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
IEC 60601-1-10:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
ISO 8835-7:2011	Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
ISO/TR 14969:2004	Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
IEC 60079-20-1:2010	Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 7396-2:2007	Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
ISO 5145:2014	Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
ISO 5356-2:2012	Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 10079-1:2015	Medical suction equipment Part 1: Electrically powered suction equipment
ISO 5367:2014	Anaesthetic and respiratory equipment — Breathing sets and connectors
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 5359:2014	Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
ISO 5362:2006	Anaesthetic reservoir bags
IEC 60079-11:2011	Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
ISO 8185:2007	Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
IEC 62304:2006+AMD1:2015 CSV	Medical device software - Software life cycle processes
ISO 3746:2010	Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
ASTM F 2761 : 2009 : R2013	Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
IEC 60601-1-3:2008+AMD1:2013 CSV	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
ISO 2878:2017	Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
ISO 80601-2-55:2011	Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 10079-3:2014	Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 407:2004	Small medical gas cylinders Pin-index yoke-type valve connections
ISO 5358:1992	Anaesthetic machines for use with humans
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 9170-1:2017	Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
ISO 10524-1:2006	Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-9:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 7396-1:2016	Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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I.S. EN ISO 80601-2-13:2012

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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