AAMI ISO 10651-5 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
Hardcopy , PDF
15-06-2020
English
01-01-2006
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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
Bibliography
Describes the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders.
| Committee |
ISO/TC 121/SC 3
|
| DevelopmentNote |
Issued by AAMI in January 2015. (01/2015)
|
| DocumentType |
Standard
|
| ISBN |
157020540X
|
| Pages |
55
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10651-5:2006 | Identical |
| 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 |
| 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 |
| 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 |
| CGA C 9 : 2013 | STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| 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 |
| 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 |
| 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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