Sterilization of health care products — Chemical indicators — Part 1: General requirements
1 Scope
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure
to sterilization processes by means of physical and/or chemical change of substances, and which are
used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization
process. They are not dependent for their action on the presence or absence of a…
Stérilisation des produits de santé — Indicateurs chimiques — Partie 1 : Exigences générales
La présente partie de l’ISO 11140 spécifie les exigences générales et les méthodes d’essai relatives aux
indicateurs qui révèlent l’exposition à des procédés de stérilisation par modification physique et/ou
chimique de substances, et qui sont utilisés pour contrôler l’obtention d’un ou de plusieurs paramètres
spécifiés pour un procédé de stérilisation. Leur action ne dépend pas de la présence ou…
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, s...
1 Scope
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging
medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of
preformed sterile barrier systems, sterile barrier systems and packaging systems.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever…
Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2 : Exigences de validatio...
1 Domaine d'application
La présente partie de l'ISO 11607 spécifie les exigences pour la mise au point et la validation des procédés
d’emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le
formage, le scellage et l’assemblage de systèmes de barrière stérile préformés, de systèmes de barrière
stérile et de systèmes d’emballage.
La…
Systems for evacuation of plume generated by medical devices
1.1 This International Standard specifies requirements and guidelines for the design, manufacture,
installation, function, performance, maintenance, servicing, documentation, testing, and commissioning
of equipment for evacuation of plume generated by medical devices.
NOTE A plume evacuation system (PES) can be a functionally independent component of a medical device
that has other functions.
1.2…
Spécification visant les fondations permanentes en bois pour les maisons et petits bâtiments
1.1
Cette norme vise le choix des matériaux, la fabrication et l’installation des fondations permanentes en bois.
1.2
La norme fournit des détails de construction particuliers pour les bâtiments d’une hauteur maximale de trois étages à partir du dessus des fondations et d’une superficie maximale de 600 m2.
1.3
La norme traite des composants pouvant faire partie intégrante des fondations…
Information technology - Security techniques - Blind digital signatures - Part 2: Discrete logarithm...
ISO/IEC 18370-2:2016 specifies blind digital signature mechanisms, together with mechanisms for three variants of blind digital signatures. The variants are blind digital signature mechanisms with partial disclosure, blind digital signature mechanisms with selective disclosure and traceable blind digital signature mechanisms. The security of all the mechanisms in ISO/IEC 18370-2:2016 is based on…
Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for ent...
ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories. NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. It does not specify the dimensions…
Medical suction equipment — Part 1: Electrically powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for electrically powered medical
and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals,
for domiciliary care of patients and for field and transport use.
This part of ISO 10079 does not apply to the following:
a) central power supply (by vacuum/compressed air…
