I.S. EN 13826:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PEAK EXPIRATORY FLOW METERS
Hardcopy , PDF
27-08-2007
English
01-01-2003
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.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Electrical safety
4.2 Mechanical safety
5 Identification, marking and documents
5.1 Marking of the scale or display
5.2 Marking of PEFM or packaging
5.3 Accompanying documents
5.4 Technical description
6 PEFM measurement ranges
7 Performance requirements
7.1 Error of measurement
7.2 Linearity
7.3 Resistance to flow
7.4 Frequency response
8 Dismantling and reassembly
9 Effects of mechanical ageing
10 Effects of dropping hand-held PEFM
Annex A (normative) - Method of determining error, repeatability
and resistance to flow of peak expiratory
flow meter output
A.1 - Principle
A.2 - Apparatus
A.3 - Procedure
A.4 - Calculations
A.5 - Test report
A.6 - Pass/fail criteria
Annex B (normative) - Method of determining frequency response
B.1 - Principle
B.2 - Apparatus
B.3 - Procedure
B.4 - Calculations for frequency response
B.5 - Test report
B.6 - Pass/fail criteria
Annex C (normative) - Test methods for determining the effects of
dismantling, ageing and dropping
C.1 - Principle
C.2 - Apparatus
C.3 - Procedures
C.4 - Calculation of effects
C.5 - Test report
Annex D (informative) - Rationale for tests and examples of test
apparatus
D.1 - Introduction
D.2 - General
D.3 - Apparatus
Annex ZA (informative) - Clauses of this European standard
addressing essential requirements or other
provisions of EU directives
Bibliography
Gives requirements for peak expiratory flow meters (PEFM) intended for the assessment of pulmonary function in spontaneously breathing humans.
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NS EN 13826 : 1ED 2003 | Identical |
| NF EN 13826 : 2003 | Identical |
| BS EN 13826:2003 | Identical |
| UNI EN 13826 : 2004 | Identical |
| SN EN 13826 : 2003 | Identical |
| NBN EN 13826 : 2003 | Identical |
| UNE-EN 13826:2004 | Identical |
| NEN EN 13826 : 2003 | Identical |
| EN 13826 : 2003 | Identical |
| DIN EN 13826:2003-09 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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