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BS EN ISO 8536-10:2015

Current
Current

The latest, up-to-date edition.

Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2015

Publisher

British Standards Institution

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.

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.

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

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 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
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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