STN EN ISO 11608-1
| Name: | STN EN ISO 11608-1 |
| Validity: | Valid |
| Number of pages: | 84 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Injekčné systémy na báze ihiel na zdravotnícke použitie. Požiadavky a skúšobné metódy. Časť 1: Injekčné systémy na báze ihiel (ISO 11608-1: 2022) |
| English title | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) |
| Release Date: | 01. 08. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.25 |
| Sorting character/National clasification code | 85 5930 |
| Level of incorporation: | idt EN ISO 11608-1:2022, idt ISO 11608-1:2022 |
| Official Journal | 07/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 11608-1:2015-07 (85 5930) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). |
| Preview: | Náhľad normy (PDF) |