Kvalitet

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 16 dec 2019
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This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.

NOTE 1 The Luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.

This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are specified in other documents:

— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);

— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);

— infusion system closure piercing connectors (ISO 8536-4).

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

NOTE 3 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this part of ISO 80369.

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This document provides guidance based on ISO/IEC 27002:2013 applied to process control systems used by the energy utility industry for controlling and monitoring the production or generation, transmission, storage and distribution of electric power, gas, oil and heat, and for the control of associated supporting processes. This includes in particular the following:

— central and distributed process control, monitoring and automation technology as well as information systems used for their operation, such as programming and parameterization devices;

— digital controllers and automation components such as control and field devices or Programmable Logic Controllers (PLCs), including digital sensor and actuator elements;

— all further supporting information systems used in the process control domain, e.g. for supplementary data visualization tasks and for controlling, monitoring, data archiving, historian logging, reporting and documentation purposes;

— communication technology used in the process control domain, e.g. networks, telemetry, telecontrol applications and remote control technology;

— Advanced Metering Infrastructure (AMI) components, e.g. smart meters;

— measurement devices, e.g. for emission values;

— digital protection and safety systems, e.g. protection relays, safety PLCs, emergency governor mechanisms;

— energy management systems, e.g. of Distributed Energy Resources (DER), electric charging infrastructures, in private households, residential buildings or industrial customer installations;

— distributed components of smart grid environments, e.g. in energy grids, in private households, residential buildings or industrial customer installations;

— all software, firmware and applications installed on above-mentioned systems, e.g. DMS (Distribution Management System) applications or OMS (Outage Management System);

— any premises housing the above-mentioned equipment and systems;

— remote maintenance systems for above-mentioned systems.

This document does not apply to the process control domain of nuclear facilities. This domain is covered by IEC 62645.

This document also includes a requirement to adapt the risk assessment and treatment processes described in ISO/IEC 27001:2013 to the energy utility industry-sector–specific guidance provided in this document.