14/30292011 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
Hardcopy , PDF
English
31-08-2015
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
effects of dismantling, ageing and dropping
Annex E (informative) - Environmental aspects
Annex F (informative) - Reference to the Essential
Principles
Bibliography
Alphabetized index of defined terms used in this standard
Annex ZA (informative) - Relationship between this
Document and the Essential Requirements
Of EU Directive 93/42/EEC
BS EN ISO 23747.
| Committee |
CH/121/5
|
| DocumentType |
Draft
|
| Pages |
35
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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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