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14/30292011 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
Available format(s)

Hardcopy , PDF

Superseded date

08-31-2015

Language(s)

English

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Superseded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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