EN ISO 23747:2015
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
08-19-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 PEFM measurement range
7 Performance requirements
8 Dismantling and reassembly
9 Effects of mechanical ageing
10 Effects of dropping a hand-held PEFM
11 Cleaning, sterilization, and disinfection
12 Compatibility with substances
13 Biocompatibility
Annex A (informative) - Rationale for tests and examples
of test apparatus
Annex B (normative) - Determination of error, repeatability,
and resistance to PEFM output
Annex C (normative) - Determination of frequency response
Annex D (normative) - Test methods for determination of the
effectsof dismantling, ageing and dropping
Annex E (informative) - Environmental aspects
Annex F (informative) - Reference to the Essential
Principles
Annex G (informative) - Terminology - Alphabetized index of
defined terms
Bibliography
Annex ZA (informative) - Relationship between this
Document and the Essential Requirements of
EU Directive 93/42/EEC
ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device.Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.NOTE Additional aspects of environmental impact are addressed in ISO 14971.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 13826. (08/2007) Supersedes PREN ISO 23747. (05/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 23747:2015 | Identical |
| DIN EN ISO 23747:2015-12 | Identical |
| NEN EN ISO 23747 : 2015 | Identical |
| UNI EN ISO 23747 : 2009 | Identical |
| NF EN ISO 23747 : 2015 | Identical |
| UNI EN ISO 23747:2015 | Identical |
| ISO 23747:2015 | Identical |
| NBN EN ISO 23747 : 2015 | Identical |
| I.S. EN ISO 23747:2015 | Identical |
| BS EN ISO 23747:2015 | Identical |
| UNE-EN ISO 23747:2016 | Identical |
| PN EN ISO 23747 : 2015 | Identical |
| NS EN ISO 23747 : 2015 | Identical |
| SS-EN ISO 23747:2015 | Identical |
| ISO 128-40:2001 | Technical drawings General principles of presentation Part 40: Basic conventions for cuts and sections |
| ISO/IEC TR 10000-1:1998 | Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework |
| ISO 10241:1992 | International terminology standards Preparation and layout |
| ISO 690:2010 | Information and documentation Guidelines for bibliographic references and citations to information resources |
| ISO 128-34:2001 | Technical drawings General principles of presentation Part 34: Views on mechanical engineering drawings |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 690-2:1997 | Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 128-44:2001 | Technical drawings General principles of presentation Part 44: Sections on mechanical engineering drawings |
| ISO 128-30:2001 | Technical drawings General principles of presentation Part 30: Basic conventions for views |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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