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BS EN ISO 26782:2009

Current
Current

The latest, up-to-date edition.

Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2010

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.

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.

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

Standards Relationship
EN ISO 26782:2009/AC:2009 Identical
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 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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