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CSA Z10651-5 : 2008 : INC : UPD 1 : 2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS

Available format(s)

Hardcopy , PDF

Superseded date

18-02-2018

Language(s)

English

Published date

01-01-2018

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Constructional requirements
6 Operational requirements
7 Performance
8 Identification, marking and documents
Annex A (informative) - Rationale
Annex B (normative) - Test methods
Annex C (informative) - Relationship between this part of
        ISO 10651 and cardiopulmonary resuscitation guidelines
Annex D (informative) - Clauses of this part of ISO 10651
        addressing the essential principles
Annex E (informative) - Terminology - Index of defined terms
Annex EA (normative) - Use of resuscitators in industrial
         environments
Bibliography

Specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders.

DevelopmentNote
Together with CSA Z10651-4, it supersedes CSA Z8382. (04/2008)
DocumentType
Standard
Pages
78
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded

ISO/IEC TR 10000-1:1998 Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework
ISO 10241:1992 International terminology standards Preparation and layout
CSA C22.2 No. 25 : 1966 ENCLOSURES FOR USE IN CLASS 2, DIVISION 1, GROUPS E, F, AND G HAZARDOUS LOCATIONS
ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
CSA ISO 11137 : 1998 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
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
CSA ISO 11134 : 0 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
CSA Z10651.3 : 0 LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
CSA ISO 11135 : 1998:R2003 MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 690-2:1997 Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof
ISO 10297:2014 Gas cylinders — Cylinder valves — Specification and type testing
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
CSA Z180.1 : 2013 COMPRESSED BREATHING AIR AND SYSTEMS
CSA C22.2 No. 60529 : 2016 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE)
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC 60027-3:2002 Letter symbols to be used in electrical technology - Part 3: Logarithmic and related quantities, and their units
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
IEC 60027-2:2005 Letter symbols to be used in electrical technology - Part 2: Telecommunications and electronics
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
IEC 60027-4:2006 Letter symbols to be used in electrical technology - Part 4: Rotating electric machines
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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