CAN/CSA-Z10651-4-08 (R2018)
Current
The latest, up-to-date edition.
Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations)
Hardcopy , PDF
English, French
01-01-2008
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Connectors
5 Operational requirements
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
Preface This is the first edition of CAN/CSA-Z10651-4, Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10651-4 (first edition, 2002-03-01). This CSA Standard, and CAN/CSA-Z10651-5-08, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators, replace CAN/CSA-Z8382-94, Resuscitators Intended for Use with Humans. Scope This European Standard specifies 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. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. Electrically- and gas-powered resuscitators are not covered by this European Standard. NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marked with R) after their number.
| DevelopmentNote |
Together with CSA Z10651-5, it supersedes CSA Z8382. (04/2008)
|
| DocumentType |
Standard
|
| ISBN |
978-1-54436-666-8
|
| Pages |
0
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Current
|
| Supersedes |
Preface This is the first edition of CAN/CSA-Z10651-4, Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10651-4 (first edition, 2002-03-01). This CSA Standard, and CAN/CSA-Z10651-5-08, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators, replace CAN/CSA-Z8382-94, Resuscitators Intended for Use with Humans. Scope This European Standard specifies 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. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. Electrically- and gas-powered resuscitators are not covered by this European Standard. NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marked with R) after their number.
| 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 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 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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