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I.S. 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

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
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/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 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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