EN ISO 7864:2016
Current
The latest, up-to-date edition.
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
31-08-2016
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
ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN ISO 7864:2016 | Identical |
| DIN EN ISO 7864:2016-12 | Identical |
| NS EN ISO 7864 : 1995 | Identical |
| NEN EN ISO 7864 : 2016 | Identical |
| NF EN ISO 7864 : 1996 | Identical |
| ISO 7864:2016 | Identical |
| DIN EN ISO 7864:2015-01 (Draft) | Identical |
| NBN EN ISO 7864 : 2016 | Identical |
| SS-EN ISO 7864 : 2016 | Identical |
| NF EN ISO 7864 : 2016 | Identical |
| BS EN ISO 7864:2016 | Identical |
| PN EN ISO 7864 : 2016 | Identical |
| UNE-EN ISO 7864:2017 | Identical |