BS EN ISO 26782:2009
Current
The latest, up-to-date edition.
Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans
Hardcopy , PDF
English
30-04-2010
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 Measurement range
7 Performance requirements
8 Constructional requirements
9 Cleaning, sterilization and disinfection
10 Biocompatibility
Annex A (informative) - Rationale
Annex B (normative) - Testing accuracy, linearity and
impedance of spirometers
Annex C (normative) - Defined test profiles
Annex D (informative) - Environmental aspects
Annex E (informative) - Reference to the essential principals
Bibliography
Alphabetized index of defined terms used in this
International Standard
Annex ZA (informative) - Relationship between this standard
and the Essential Requirements of
EU Directive 93/42/EEC
Defines requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg.
| Committee |
CH/121/9
|
| DevelopmentNote |
To be read in conjunction with BS EN 60601-1. Supersedes 07/30157348 DC. (10/2009)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10kg. This International Standard applies to a spirometer that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. Devices intended for continuously monitoring patients are outside the scope of this International Standard.
| Standards | Relationship |
| ISO 26782:2009 | Identical |
| ISO 26782:2009/Cor 1:2009 | Identical |
| EN ISO 26782:2009/AC:2009 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 23747:2015 | Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| 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/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| PD 6461-1:1995 | General metrology Basic and general terms (VIM) |
| 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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