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I.S. EN ISO 10651-4:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
Available format(s)

Hardcopy , PDF

Superseded date

04-06-2023

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Connectors
5 Operational requirement
6 Ventilatory requirement
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
Annex ZA (Informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Describes 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.

DocumentType
Standard
Pages
38
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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
EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
EN 980:2008 Symbols for use in the labelling of medical devices

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