I.S. EN ISO 8359:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS (ISO 8359:1996)
Hardcopy , PDF
08-02-2014
English
01-01-2009
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.
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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Superseded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 |
| Standards | Relationship |
| UNE-EN ISO 8359:2009 | Identical |
| SN EN ISO 8359 : 2009 AMD 1 2012 | Identical |
| NEN EN ISO 8359 : 2009 AMD 1 2012 | Identical |
| UNI EN ISO 8359 : 2012 | Identical |
| DIN EN ISO 8359:2009-08 | Identical |
| ISO 8359:1996 | Identical |
| NBN EN ISO 8359 : 2009 AMD 1 2012 | Identical |
| NF EN ISO 8359 : 2009 AMD 1 2012 | Identical |
| BS EN ISO 8359 : 2009 | Identical |
| NS EN ISO 8359 : 2009 AMD 1 2012 | Identical |
| 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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