• BS EN ISO 80601-2-13:2012+A2:2019

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation

    Available format(s):  Hardcopy, PDF

    Superseded date:  17-06-2022

    Language(s):  English

    Published date:  11-01-2020

    Publisher:  British Standards Institution

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    Scope - (Show below) - (Hide below)

    IEC60601‑1:2005+A1:2012, Clause1 applies, except as follows: 201.1.1 *Scope Replacement: This International Standard is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This International Standard specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system;anaesthetic breathing system;anaesthetic gas scavenging system;anaesthetic vapour delivery system;anaesthetic ventilator;monitoring equipment;alarm system;protection device. NOTE1 Monitoring equipment, alarm systems and protection devices are summarized in TableAA.1. An anaesthetic workstation supplied complete and its individual components are considered as me equipment or me systems with regard to the general standard. NOTE2 The applicability of this International Standard is indicated in TableAA.2. This International Standard is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components 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 an anaesthetic workstation and its individual components, as relevant. hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of this International Standard are not covered by specific requirements in this International Standard except in 7.2.13 and 8.4.1 of the general standard. NOTE3 See also 4.2 of the general standard. This International Standard is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by AnnexBB. 201.1.2 Object Replacement: The object of this particular standard is to establish particular basic safety and essential performance requirements for an anaesthetic workstation and its individual components designed for use in the anaesthetic workstation (as defined in 201.3.211) and its accessories. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause2 of the general standard and Clause201.2 of this particular standard. IEC60601‑1‑3:2008, IEC60601‑1‑9:2007+AMD1:2013 and IEC60601‑1‑11:2010 do not apply. 201.1.4 Particular standards Replacement: In the IEC60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards, as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC60601‑1:2005+A1:2012 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause4 of the IEC60601‑1‑2 collateral standard, 206.4 in this particular standard addresses the content of Clause4 of the IEC60601‑1‑6 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 to 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC60601‑1‑2, 206 for IEC60601‑1‑6, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. If an anaesthetic workstation is supplied with physiological monitoring, having more than one applied part on the patient, then IEC60601‑2‑49 applies. Measured parameters related to the inherent function of an anaesthetic workstation (i.e. airway pressure, ventilation volume, oxygen concentration, volatile anaesthetic agent concentration, CO2/N2O), including derived and related parameters such as spontaneous ventilation volume or CO2 production, are not considered to be a physiological monitoring unit as per IEC60601‑2‑49.

    General Product Information - (Show below) - (Hide below)

    Committee CH/121
    Document Type Standard
    Product Note Implementation of ISO amendment 2:2019 with CEN endorsement A2:2019
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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