BS EN ISO 8536-4 : 2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
Hardcopy , PDF
04-02-2020
English
01-01-2013
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Withdrawn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 |
| SN EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| NF EN ISO 8536-4 : 2013 | Identical |
| NEN EN ISO 8536-4 : 2013 | Identical |
| UNI EN ISO 8536-4 : 2013 | Identical |
| I.S. EN ISO 8536-4:2013 | Identical |
| 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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