AAMI ISO 26782 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
09-13-2021
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Superseded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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