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AAMI ISO 26782 : 2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS

Superseded date

09-13-2021

Published date

05-15-2017

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI
adoption of ISO 26782:2009
and ISO 26782:2009/Cor.1:2009
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

Describes requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg.

DevelopmentNote
2015 edition incorporates COR 1 2015. (05/2017)
DocumentType
Standard
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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 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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