BS EN ISO 8536-4 : 2013
Withdrawn
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
Hardcopy , PDF
English
01-01-2013
02-04-2020
1 Scope
2 Normative refere
3 General requirements
4 Designation
5 Materials
6 Physical requirements
7 Chemical requi
8 Biological requ
9 Labelling
10 Packaging
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Describes requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 02/564514 DC (09/2004) Supersedes 06/30160058 DC. (04/2007) 2013 Edition Re-Issued in August 2013 & incorporates AMD 1 2013. Supersedes 12/30255153 DC. (09/2013)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 8536-4:2010 | Identical |
| DIN EN ISO 8536-4:2013-07 | Identical |
| NBN EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| NS EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| NF EN ISO 8536-4 : 2013 | Identical |
| NEN EN ISO 8536-4 : 2013 | Identical |
| I.S. EN ISO 8536-4:2013 | Identical |
| EN ISO 8536-4:2013 | Equivalent |
| UNE-EN ISO 8536-4:2013 | Identical |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 80000-4:2006 | Quantities and units — Part 4: Mechanics |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 291:2008 | Plastics — Standard atmospheres for conditioning and testing |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO/TS 11135-2:2008 | Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
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