I.S. 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
01-01-2009
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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.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 26782:2009 | 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/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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