EN ISO 10651-4:2009
Withdrawn
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
04-08-2009
03-21-2010
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
ISO 10651-4:2002 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.ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.Rationale statements are given for ISO 10651-4:2002.
| Committee |
CEN/TC 215
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 10651-4 : 2009 | Identical |
| NS EN ISO 10651-4 : 2009 | Identical |
| NEN EN ISO 10651-4 : 2009 | Identical |
| PN EN ISO 10651-4 : 2009 | Identical |
| NF EN ISO 10651-4 : 2009 | Identical |
| NBN EN ISO 10651-4 : 2009 | Identical |
| I.S. EN ISO 10651-4:2009 | Identical |
| ISO 10651-4:2002 | Identical |
| BS EN ISO 10651-4:2002 | Identical |
| DIN EN ISO 10651-4:2009-08 | Identical |
| BS EN ISO 10651-4:2009 | Equivalent |
| BS EN ISO 10651-4:2009 | Identical |
| UNE-EN ISO 10651-4:2009 | Identical |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| DIN EN 13544-2:2010-01 | Respiratory therapy equipment - Part 2: Tubing and connectors (includes Amendment A1:2009) |
| I.S. EN 13544-2:2002 | RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS |
| 00/563810 DC : DRAFT AUG 2000 | BS EN 13544-2 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS |
| BS EN 13544-2 : 2002 | RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS |
| UNE-EN 13544-2:2003 | Respiratory therapy equipment - Part 2: Tubing and connectors. |
| 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 (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |