I.S. EN ISO 7864:2016
Current
The latest, up-to-date edition.
STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
Hardcopy , PDF
English
01-01-2016
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.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Packaging
6 Information supplied by the manufacturer
Annex A (normative) - Method for preparation
of extracts
Annex B (informative) - Fragmentation test for
medical needles
Annex C (informative) - Determination of flow
rate through the needle
Annex D (informative) - Test method for measuring
the penetration force and drag force for needles
Annex E (informative) - Needle bonding strength
test method
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC [OJ L 169] aimed to be
covered
Defines requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 7864 : 2016 | Identical |
| NS EN ISO 7864 : 1995 | Identical |
| NEN EN ISO 7864 : 2016 | Identical |
| BS EN ISO 7864:2016 | Identical |
| EN ISO 7864:2016 | Identical |
| NF EN ISO 7864 : 1996 | Identical |
| ISO 7864:2016 | Identical |
| DIN EN ISO 7864:2015-01 (Draft) | Identical |
| DIN EN ISO 7864:2016-12 | Equivalent |
| UNE-EN ISO 7864:2017 | Identical |
| ISO 8362-7:2006 | Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part |
| EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO/TR 19244:2014 | Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| EN ISO 6009:2016 | Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) |
| ISO 8362-4:2011 | Injection containers and accessories — Part 4: Injection vials made of moulded glass |
| ISO 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| ISO 8362-3:2001 | Injection containers and accessories — Part 3: Aluminium caps for injection vials |
| ISO 8362-6:2010 | Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials |
| ISO 8362-5:2016 | Injection containers and accessories — Part 5: Freeze drying closures for injection vials |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 8362-1:2009 | Injection containers and accessories — Part 1: Injection vials made of glass tubing |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| 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 6009:2016 | Hypodermic needles for single use — Colour coding for identification |
| EN 1707:1996 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
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