BS EN ISO 8536-10:2015
Current
The latest, up-to-date edition.
Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment
Hardcopy , PDF
English
30-06-2015
Foreword
1 Scope
2 Normative references
3 Materials
4 Physical requirements
5 Chemical requirements
6 Biological requirements
7 Packaging
8 Labelling
9 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical devices
Bibliography
Pertains to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
Committee |
CH/212
|
DevelopmentNote |
Supersedes 02/564517 DC. (01/2005) Supersedes 13/30284773 DC. (06/2015)
|
DocumentType |
Standard
|
Pages |
22
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. This part of ISO 8536 includes the following: two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. units with injection site or check valve; stoppers or adapters. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Standards | Relationship |
NF EN ISO 8536-10 : 2015 | Identical |
NEN EN ISO 8536-10 : 2015 | Identical |
ISO 8536-10:2015 | Identical |
NS EN ISO 8536-10 : 2004 | Identical |
EN ISO 8536-10:2015 | Identical |
I.S. EN ISO 8536-10:2015 | Identical |
DIN EN ISO 8536-10:2015-11 | Identical |
UNI EN ISO 8536-10 : 2005 | Identical |
NBN EN ISO 8536-10 : 2015 | Identical |
UNE-EN ISO 8536-10:2015 | Identical |
SN EN ISO 8536-10 : 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 8536-12:2007 | Infusion equipment for medical use Part 12: Check valves |
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 8536-8:2015 | Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus |
EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
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 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
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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