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I.S. EN ISO 8359:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 8359:1996)
Available format(s)

Hardcopy , PDF

Superseded date

08-02-2014

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Describes safety requirements for continuous-flow oxygen concentrators.

DocumentType
Standard
Pages
53
PublisherName
National Standards Authority of Ireland
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Superseded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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