CEI EN 60601-2-13 : 2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
Hardcopy , PDF
01-07-2020
English - Italian
01-01-2007
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INTRODUCTION
SECTION ONE - GENERAL
SECTION TWO - 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
SECTION EIGHT - ACCURACY OF OPERATING
DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION
AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
SECTION 101 - ADDITIONAL CLAUSES
SPECIFIC TO ANAESTHETIC
GAS DELIVERY SYSTEMS
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
Bibliography
Index of defined terms
Annex ZA (normative) - Normative
references to international
publications with their
corresponding European
publications
Annex ZZ (informative) - Coverage
of Essential Requirements
of EC Directives
Specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM as well as individual devices designed for use in an ANAESTHETIC SYSTEM.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-142. (12/2006)
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Withdrawn
|
| Standards | Relationship |
| IEC 60601-2-13:2003+AMD1:2006 CSV | Identical |
| EN 60601-2-13 : 2006 AMD 1 2007 | Identical |
| 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 |
| 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 |
| 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 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| 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 8835-4:2004 | Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
| 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 |
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