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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s):

Superseded date: 13-09-2021

Language(s):

Published date: 15-05-2017

Publisher: Association for the Advancement of Medical Instrumentation

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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

Abstract - (Show below) - (Hide below)

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

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Development Note	2015 edition incorporates COR 1 2015. (05/2017)
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	AAMI ISO 26782:2015+COR1:2015

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 26782:2009	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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