Palvelualojen työnantajat PALTA

 

This document specifies dimensional requirements for base-mounted in-line fuel injection pumps and high-pressure supply pumps for common rail fuel injection systems for diesel (compression-ignition) engines.

 

This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

 

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

 

ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following: - oxygen; - nitrous oxide; - medical air; - carbon dioxide; - oxygen/nitrous oxide mixtures (see Note 1); - helium/oxygen mixtures; - (*) oxygen 93; - gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above; - air for driving surgical tools; - nitrogen for driving surgical tools; - vacuum. NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems. NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396-2. This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems. This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to: a) acute care healthcare facilities; b) internal patient continuing care healthcare facilities; c) long-term care facilities; d) community-based providers; e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices). NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities. ISO 7396-1:2016 applies to the following different types of oxygen supply systems: - supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%; - supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%; NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%. ISO 7396-1:2016 also applies to: - extensions of existing pipeline distribution systems; - modifications of existing pipeline distribution systems; - modifications or replacement of supply systems or sources of supply. Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396. NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601-2-69. (*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients. ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry. ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

 

This document establishes a methodology framework for testing metal-made articles in contact with foodstuffs for use in domestic microwave applicators. An experimental method aiming at qualifying this class of articles is proposed. The objectives of the method are two-folds: ensuring a correct eating efficiency considering a standard microwave heating cycle and guarantying the user safety notably regarding the risk of electrical discharge.

 

This document specifies the parameters used on the service interface of the recording equipment. Some of them are specified in detail in this document, while others are given in the ISO 14299 series.

 

This document specifies the CAN-based data communication between the display unit and other devices connected to an SAE J1939-based in-vehicle network. The provided requirements and recommendations cover physical, data link, network, and application layers according to the OSI reference model. Additionally, it specifies the parameter groups, which are supported.

 

This document specifies the CAN-based and K-Line-based communication protocols between recording equipment and service tools for software download and calibration purposes. The requirements and recommendations provided herein address the physical, data link, network, session, and application layers in accordance with the OSI reference model as well as the unified diagnostics services.

 

 

This document specifies the minimum requirements for complete single-vision ready-to-wear near-vision spectacles. These spectacles are not intended for regular use without the approval of an eye-care professional.

 

This document specifies the in-vehicle information (IVI) data structures that are required by different intelligent transport system (ITS) services for exchanging information between ITS stations (ITS-S). A general, extensible data structure is specified, which is split into structures called containers to accommodate current-day information. Transmitted information includes IVI such as contextual speed, road works warnings, vehicle restrictions, lane restrictions, road hazard warnings, location-based services and re-routing. The information in the containers is organized in sub-structures called data frames and data elements, which are described in terms of their content and syntax. The data structures are specified as communications-agnostic. This document does not provide the communication protocols. This document provides scenarios for usage of the data structure, e.g. in case of real time, short-range communications.

 

This document specifies the in-vehicle information (IVI) data structures that are required by different intelligent transport system (ITS) services for exchanging information between ITS stations (ITS-S). A general, extensible data structure is specified, which is split into structures called containers to accommodate current-day information. Transmitted information includes IVI such as contextual speed, road works warnings, vehicle restrictions, lane restrictions, road hazard warnings, location-based services and re-routing. The information in the containers is organized in sub-structures called data frames and data elements, which are described in terms of their content and syntax. The data structures are specified as communications-agnostic. This document does not provide the communication protocols. This document provides scenarios for usage of the data structure, e.g. in case of real time, short-range communications.

 

This document is applicable to helical steel suspension springs used in the suspension of rail vehicles. It deals specially with cylindrical compression springs made from round section steel bars of constant diameter and with constant inclination of coiling. It deals also with helical springs with different shapes (e.g. conical and/or inclination of coiling not constant and/or steel bar with other cross sections, etc.). This document gives guidance for: specification of technical and quality requirements; — the approval procedure and quality assurance of production methods; — the examinations and tests to be carried out; — the delivery conditions.

 

 

This document specifies the SAE J1939-based application layer, the payload of messages, and parameter groups for electronically controlled braking systems, including anti-lock braking systems (ABS), vehicle dynamics control systems (VDC), and running gear equipment, to ensure the interchange of digital information between road vehicles with a maximum authorized total mass greater than 3 500 kg and their towed vehicles, including communication between towed vehicles. Conformance and interoperability test plans are not part of this document.

 

 

This document specifies requirements for underground pipework systems used to transfer liquid fuels and their vapours at petrol filling stations. Minimum performance requirements covering fitness for purpose, safety and environmental protection are given. This document is applicable to pipework made from thermoplastics, which can include some degree of reinforcement, and to flexible metal pipework. It does not apply to fibre reinforced thermosets, commonly referred to as glass fibre reinforced plastic (GRP), nor to rigid metals. This document is applicable to: - delivery pipes from tanks to dispensers, including positive pressure, vacuum suction and siphon modes; - fill pipes from road tankers to tanks; - vapour recovery and vent pipework; - pipework for secondary containment; - fittings. It does not apply to pipework for use with liquefied petroleum gas.

 

This document specifies the communication interface between motion sensor and recording equipment. This includes mechanical, electrical and logical requirements.

 

This document specifies the test method and performance metrics to evaluate the behaviour of a vehicle equipped with rear cross traffic alerting system during several collision scenarios. These collisions occur during straight-line reverse manoeuvres when the vehicle under test (VUT) approaches other vehicles or traffic participants. This document is applicable to M1 category vehicles. NOTE Depending on accidentology, only a part of the scenarios can be used for an evaluation of performance.