Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-base...
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…
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers ...
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are…
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated f...
This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).
General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d)…
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body del...
This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
NOTE 1 …
Émaux vitrifiés — Libération depuis les articles émaillés en contact avec les aliments — Méthode d&#...
Le présent document spécifie une méthode d’essai de simulation pour la détermination de la libération d’ions métalliques depuis les articles émaillés destinés à entrer en contact avec les denrées alimentaires.
Le présent document spécifie également les limites relatives à la libération d’ions métalliques depuis les articles émaillés destinés à entrer en contact avec les denrées alimentaires.
Le…
Vitreous and porcelain enamels — Release from enamelled articles in contact with food — Methods of t...
This document specifies a simulating method of test for determination of the release of metal-ions from enamelled articles, which are intended to come into contact with food.
This document also specifies limits for the release of metal-ions from enamelled articles, which are intended to come into contact with food.
This document is applicable to enamelled articles, including tanks and vessels,…
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d’essai — Partie 4: ...
Le présent document spécifie les exigences et les méthodes d'essai pour les systèmes d'injection à aiguille (NIS) contenant de l'électronique avec ou sans logiciel (NIS-E).
Le système d'injection à aiguille contenant de l'électronique peut être à usage unique ou réutilisable et peut fonctionner avec ou sans connexions électriques/conductrices à d'autres dispositifs.…
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-base...
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-…
Standard test method for assessing the ignition propensity of cigarettes
This document specifies a test method for testing the capability of a cigarette, positioned on one of three standard substrates, to extinguish or to generate sufficient heat to continue burning, and thus potentially cause ignition of bedding or upholstered furniture. This document is only applicable to factory-made cigarettes that burn along the length of a tobacco column.
This is a performance-…
