Name: EN ISO 23747:2015
Brand: CEN

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)

Published date

19-08-2015

Publisher

Comite Europeen de Normalisation

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	PREN ISO 23747 : DRAFT 2008 EN 13826 : 2003

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