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UNI EN ISO 8359 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
Superseded date

13-09-2022

Published date

01-01-2012

Foreword
Section 1 - General
Section 2 - Safety requirements
Section 3 - Protection against electric shock hazards
Section 4 - Protection against mechanical hazards
Section 5 - Protection against hazards from unwanted or
            excessive radiation
Section 6 - Protection against hazards of explosions in
            medically used rooms
Section 7 - Protection against excessive temperatures and
            other safety hazards
Section 8 - Accuracy of operating data and protection against
            hazardous output
Section 9 - Abnormal operation and fault conditions;
            environmental tests
Section 10 - Constructional requirements
Section 11 - Additional clauses
Annexes
Annex N (normative) - Test apparatus
Annex P (informative) - Rationale statement
Annex Q (informative) - Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Defines safety requirements for continuous-flow oxygen concentrators.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
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
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals

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