I.S. EN ISO 8536-8:2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
11 Disposal
Annex A (normative) - Physical tests
Annex B (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
Provides users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 8536-8 : 2015 | Identical |
| NBN EN ISO 8536-8 : 2015 | Identical |
| NS EN ISO 8536-8 : 2004 | Identical |
| DIN EN ISO 8536-8:2015-11 | Identical |
| NF EN ISO 8536-8 : 2015 | Identical |
| EN ISO 8536-8:2015 | Identical |
| BS EN ISO 8536-8:2015 | Identical |
| ISO 8536-8:2015 | Identical |
| UNE-EN ISO 8536-8:2015 | 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 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 8536-9:2015 | Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment |
| 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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