• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

EN 60601-2-13 : 2006 AMD 1 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
Superseded date

01-12-2012

Published date

12-01-2013

INTRODUCTION
SECTION ONE - GENERAL
  1 Scope and object
  2 Terminology and definitions
  3 General requirements
  4 General requirements for tests
  6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
  10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
                HAZARDS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM
               UNWANTED OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
              OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE
                TEMPERATURES AND OTHER SAFETY HAZARDS
  43 Fire prevention
  44 Overflow, spillage, leakage, humidity, ingress
       of liquids, cleaning, sterilization and disinfection
  49 Interruption of the POWER SUPPLY
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
  51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS
               ENVIRONMENTAL TESTS
  52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
  54 General
  56 Components and general assembly
  57 MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS
              DELIVERY SYSTEMS
  101 Medical gas supply
  102 Medical gas pipeline inlet connections
  103 Medical gas supply pressure monitoring
  104 Medical gas supply PRESSURE REGULATORs
  105 Anaesthetic gas delivery system piping
  106 Gas flow metering
  107 Gas mixer
  108 Oxygen flush
  109 Fresh gas outlet
  110 Checklist
Annex AA (informative) - Guidance and rationale for
         particular clauses and subclauses in this
         particular standard
Annex BB (informative) - MONITORING DEVICES, ALARM
         SYSTEM(S) and PROTECTION DEVICES
Annex CC (informative) - Separate devices of an ANAESTHETIC
         SYSTEM
Annex DD (normative) - Test for flammability of anaesthetic
         agent
Annex EE (informative) - Clauses of this International
         Standard Addressing the essential requirements
         or other provisions of EU directives
Annex ZA (normative) - Normative references to international
                       publications with their
                       corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements
                         of EC Directives
Bibliography
Index of defined terms

Specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM as well as individual devices designed for use in an ANAESTHETIC SYSTEM.

Committee
TC 62
DevelopmentNote
Together with EN ISO 8835-2, EN ISO 8835-3, EN ISO 8835-4 and EN ISO 8835-5 supersedes EN 740. (12/2007)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 9703-3:1998 Anaesthesia and respiratory care alarm signals Part 3: Guidance on application of alarms
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
ISO 9918:1993 Capnometers for use with humans Requirements
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 32:1977 Gas cylinders for medical use — Marking for identification of content
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 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
ISO 10524:1995 Pressure regulators and pressure regulators with flow-metering devices for medical gas systems
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.