I.S. 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)
Hardcopy , PDF
English
01-01-2015
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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National Foreword
European foreword
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.
| DevelopmentNote |
Supersedes I.S. EN 13826. (09/2007)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| 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 |
| BS 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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