BS 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
Hardcopy , PDF
English
08-31-2015
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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
Describes requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans.
| Committee |
CH/121/9
|
| DevelopmentNote |
Supersedes BS EN 13826 and 06/30136646 DC. (08/2007) Supersedes 08/30192545 DC. (04/2009) Supersedes 14/30292011 DC. (08/2015)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard 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 AnnexE. NOTE Additional aspects of environmental impact are addressed in ISO14971.
| Standards | Relationship |
| SN EN ISO 23747:2015 | Identical |
| DIN EN ISO 23747:2015-12 | Identical |
| NEN EN ISO 23747 : 2015 | Identical |
| NF EN ISO 23747 : 2015 | Identical |
| ISO 23747:2015 | Identical |
| NBN EN ISO 23747 : 2015 | Identical |
| I.S. EN ISO 23747:2015 | Identical |
| UNE-EN ISO 23747:2016 | Identical |
| NS EN ISO 23747 : 2015 | Identical |
| 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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