Name: EN ISO 26782:2009/AC:2009
Brand: CEN

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)

Amendment of

EN ISO 26782:2009

Published date

15-11-2009

Publisher

Comite Europeen de Normalisation

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.

Committee	CEN/TC 215
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
ISO 26782:2009/Cor 1:2009	Identical
NF EN ISO 26782 : 2009	Identical
I.S. EN ISO 26782:2009	Identical
ISO 26782:2009	Identical
DIN EN ISO 26782:2010-02	Identical
PN EN ISO 26782 : 2009 AC 2010	Identical
SN EN ISO 26782 : 2010 CORR 2010	Identical
BS EN ISO 26782:2009	Identical
NEN EN ISO 26782 : 2009 C1 2009	Identical
NBN EN ISO 26782 : 2009 COR 2009	Identical
UNI EN ISO 26782 : 2009	Identical
NS EN ISO 26782 : 2009 AC 2009	Identical
UNE-EN ISO 26782:2010	Identical
SN EN ISO 26782:2010	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