Lyhenteet

- A / A +

Takaisin

SFS-EN ISO 7886-4:2019:en

Sterile hypodermic syringes for single use. Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)

Tuote ladattavissa heti Toimitusaika on noin 1 - 2 työpäivää Toimitusaika on 3 - 5 työpäivää.
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document.
NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Sidokset
Velvoittavat viittaukset
ASTM D 5276:1998 Standard Test Method for Drop Test of Loaded Containers by Free Fall
ASTM D 999:2001 Standard Test Methods for Vibration Testing of Shipping Containers
ISO 3696:1987 Water for analytical laboratory use -- Specification and test methods
Direktiivi
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet

http://ec.europa.eu »
Vahvistuspäivä
15.03.2019
Julkaisupäivä
19.03.2019
Painos
3
Sivumäärä
17
Julkaisun kieli
englanti

Takaisin