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EN 12598 : 1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

01-11-2004

Published date

12-01-2013

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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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