AAMI ISO 10651-4 : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
Hardcopy , PDF
English
01-01-1999
30-08-2021
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Connectors
5 Operational requirements
6 Ventilatory requirements
7 Storage and operating conditions
8 Requirements for resuscitator,
or parts, supplied sterile
9 Marking
10 Information to be provided by the manufacturer
in operating and maintenance instructions
Annex A (normative) - Test methods
Annex B (informative) - Rationale
Bibliography
Defines requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate.
| DevelopmentNote |
Issued by AAMI in January 2015. (01/2015)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10651-4:2002 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
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