EN 12598 : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
01-11-2004
12-01-2013
Foreword
1 General
1.1 R Scope and object
1.2 Normative references
1.3 Definitions and terminology
1.4 General requirements and requirements for test
1.5 Classification
1.6 Identification, marking and documents
1.7 Power input
2 Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 R Environmental conditions
2.4 Clause 11 of the general standard does not apply
2.5 Clause 12 of the general standard does not apply
3 Protection against electric shock hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 R Separation
3.6 Protective earthing, functional earthing and
potential equalization
3.7 R Continuous leakage currents and patient auxiliary
currents
3.8 Dielectric strength
4 Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surfaces, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
5 Protection against hazards from unwanted or excessive
radiation
5.1 X-radiation
5.2 Alpha, beta, gamma, neutron radiation and other
particle radiation
5.3 Microwave radiation
5.4 Light radiation (including lasers)
5.5 Infrared radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility
6 Protection against hazards of ignition of flammable
anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 R Common requirements for category AP and category
APG equipment
6.4 Requirements and tests for category AP equipment,
parts and components thereof
7 Protection against excessive temperatures and other
safety hazards
7.1 Excessive temperatures
7.2 R Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human errors
7.6 Electrostatic charges
7.7 Biocompatibility
7.8 Interruption of the power supply
8 Accuracy of operating data and protection against
hazardous output
8.1 Accuracy of operating data
8.2 Protection against hazardous output
9 Fault conditions causing overheating and/or mechanical
damage; environmental tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
10 Constructional requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Main parts, components and layout
10.5 Protective earthing - terminals and connections
10.6 Construction and layout
11 Additional requirements
11.1 R Interfering gas and vapour effects
11.2 Contamination of breathing systems
11.3 R Gas leakage and sampling loss
11.4 Connections
11.5 Rise time
Annex AA (informative) Rationale
Annex BB (informative) Bibliography
Annex CC (normative) Test method for anaesthetic agents
for non-flammability
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
Gives particular requirements for oxygen monitors, meant for use for determination of the oxygen level in gas mixtures. Includes both diverting and non-diverting oxygen monitors.
Committee |
CEN/TC 215
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
Standards | Relationship |
UNI EN 12598 : 2002 | Identical |
UNE-EN 12598:1999 | Identical |
NF EN 12598 : 2000 | Identical |
BS EN 12598:1999 | Identical |
NEN EN 12598 : 1999 | Identical |
NBN EN 12598 : 1999 | Identical |
DIN EN 12598:1999-06 | Identical |
I.S. EN 12598:1999 | Identical |
SN EN 12598 : 1999 | Identical |
NS EN 12598 : 1ED 1999 | Identical |
CEN/TS 14507-1:2003 | Inhalational nitric oxide systems - Part 1: Delivery systems |
EN ISO 21647:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) |
DD CEN/TS 14507-1:2003 | Inhalational nitric oxide systems Delivery systems |
02/564924 DC : DRAFT NOV 2002 | ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA Z21647 : 2007 : R2012 : FR | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
09/30197590 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
I.S. CEN/TS 14507-1:2003 | INHALATIONAL NITRIC OXIDE SYSTEMS - PART 1: DELIVERY SYSTEMS |
UNI EN ISO 21647 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
I.S. EN ISO 21647:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
PREN ISO 80601-2-55 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA Z21647:2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
UNI EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
CSA Z21647 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
BS EN ISO 21647:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors |
EN 475 : 1995 | MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS |
EN 1281-2 : 1995 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS |
EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
IEC 60079-3:1990 | Electrical apparatus for explosive gas atmospheres - Part 3: Spark-test apparatus for intrinsically-safe circuits |
EN 1281-1:1997/A1:1998 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS |
EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
EN 980:2008 | Symbols for use in the labelling of medical devices |
EN 60801-2 : 1993 | ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991) |
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