UNI CEI EN 15546-1 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
03-03-2011
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for small bore connectors
5 Small bore connector requirements for specific
medical applications
6 Procedure to assess proposed new small bore
connector for inclusion in this series of Standards
6.1 General
6.2 Procedure to be carried out by proposer of new
small bore connector to assess the noninterchangeability
with existing small bore connectors
6.3 Design review
Annex A (informative) - Rationale for this Standard
Annex B (informative) - Overview of small bore connector
allocation
Annex C (informative) - Small bore connectors for vascular
systems applications
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC Medical devices
Bibliography
Describes general requirements for small bore connectors used in specific medical applications to convey liquids or gases to or from a patient or via intermediate systems.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 15546-1 : 2008 | Identical |
| EN 15546-1:2008 | Identical |
| ISO 3040:2016 | Geometrical product specifications (GPS) Dimensioning and tolerancing Cones |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 13014:2000/AC:2002 | CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT |
| EN 1707:1996 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - 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 |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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