CEI EN 60601-2-13 : 2007
Withdrawn
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
Hardcopy , PDF
English - Italian
11-01-2007
08-01-2020
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Withdrawn
|
| Supersedes |
| 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 |