Name: AAMI ISO 26782 : 2015
Brand: AAMI

AAMI ISO 26782 : 2015

Superseded

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

Superseded date

13-09-2021

Published date

15-05-2017

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Superseded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	AAMI ISO 26782:2015+COR1:2015

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