BS EN ISO 8536-9:2015
Current
The latest, up-to-date edition.
Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment
Hardcopy , PDF
English
30-06-2015
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Packaging
9 Labelling
10 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Storage volume
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EC Directive 93/42/EEC on medical devices
Bibliography
Pertains to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 02/564516 DC. (01/2005) Supersedes 13/30284770 DC. (06/2015)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: syringe pump lines (SPL); connecting lines (CL); lines with integrated injection cannula (LIC). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
| Standards | Relationship |
| NBN EN ISO 8536-9 : 2015 | Identical |
| NS EN ISO 8536-9 : 2004 | Identical |
| I.S. EN ISO 8536-9:2015 | Identical |
| NF EN ISO 8536-9 : 2015 | Identical |
| DIN EN ISO 8536-9:2015-11 | Identical |
| NEN EN ISO 8536-9 : 2015 | Identical |
| ISO 8536-9:2015 | Identical |
| EN ISO 8536-9:2015 | Identical |
| UNE-EN ISO 8536-9:2015 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 8536-8:2015 | Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus |
| EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
| ISO 8536-11:2015 | Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 8536-4:2010 | Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
| ISO 8536-10:2015 | Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment |
| 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 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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