CEI EN 80369-5 : 1ED 2017
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
17-04-2017
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for sphygmomanometer and cuff
SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for the
limb cuff inflation APPLICATION
Annex C (normative) - Reference CONNECTORS
Annex D (informative) - Assessment of MEDICAL DEVICES and
their attributes with CONNECTIONS within this
APPLICATION
Annex E (informative) - Summary of the usability requirements
for SMALL-BORE CONNECTORS for limb cuff
inflation APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
design requirements for limb cuff inflation APPLICATIONS
Annex G (informative) - Summary of assessment of the design of
the CONNECTORS for limb cuff inflation APPLICATION
Annex H (informative) - Obsolete limb cuff inflation CONNECTOR
Annex I (informative) - Air leakage by pressure decay TEST METHOD
Annex J (informative) - Resistance to separation from axial load
TEST METHOD
Annex K (informative) - Reference to the essential principles
Index of defined terms
Bibliography
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Relationship between this European
standard and the essential requirements of Directive
93/42/EEC [OJ L 169] aimed to be covered
Defines dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-251. (04/2017) New child AC 2022 is added
|
| DocumentType |
Standard
|
| ProductNote |
New child AC 2022 is added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| EN ISO 5356-1:2015 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015) |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| EN ISO 5356-2:2012 | Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012) |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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