UNE-EN ISO 23747:2016
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
Spanish, Castilian, English
20-01-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Safety for PEFMs that utilize electricity
4.2 Mechanical safety for all PEFMs
5 Identification, marking and documents
5.1 Marking of the scale or display
5.2 Marking of PEFM or packaging
5.3 Instructions for use
5.4 Technical description
6 PEFM measurement range
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 a hand-held PEFM
11 Cleaning, sterilization and disinfection
11.1 Re-usable PEFM and parts
11.2 PEFM and parts delivered sterile
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 effects
of dismantling, ageing and dropping
Annex E (informative) Environmental aspects
Annex F (informative) Reference to the essential principals
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements
of EU Directive 93/42/EEC
Bibliography
Defines requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans.
| Committee |
CTN 110
|
| DevelopmentNote |
Supersedes UNE EN 13826. (01/2008)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| 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 |
| EN ISO 23747:2015 | Identical |
| I.S. EN ISO 23747:2015 | Identical |
| BS EN ISO 23747:2015 | Identical |
| NS 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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