09/30173644 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
31-07-2011
English
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for small-bore connectors
5 Requirements for small-bore connectors for
specific applications
5.1 Small-bore connector incompatibility
5.2 Intravascular or hypodermic applications
5.3 Breathing systems and driving gases applications
5.4 Enteral applications
5.5 Urethral and urinary applications
5.6 Limb cuff inflation applications
5.7 Neuraxial applications
5.8 Alternative small-bore connectors
6 Procedure to assess a proposed new design of
small-bore connector for inclusion in this
series of Standards
6.1 General
6.2 Proposal initiation
6.3 Procedure to assess acceptability and
non-interconnectable characteristics
6.3.1 Design
6.3.2 Design realization
6.3.3 Design verification
6.3.4 Design validation
6.4 Design review
6.5 Subsequent parts of this series of Standards
Annex A (informative) - Rationale
Annex B (normative) - Mechanical tests for verifying
non-interconnectable characteristics
Annex C (informative) - Applications of small-bore connectors
Annex D (informative) - Reference to the Essential Principles
Annex ZA (informative) - Relationship between this Document
and the Essential Requirements of EU Directive
93/42/EEC
Bibliography
Terminology - Alphabetized index of defined terms
BS EN ISO 80369-1
| Committee |
CH/84/-/1
|
| DocumentType |
Draft
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 80369-1 : DRAFT 2009 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
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