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AS+: Austrian Standards International
AS+, the Austrian Standards Institute, is a nonprofit organization that develops and publishes standards on a wide variety of topics. Headquartered in Vienna, Austria, ON is Austria's national standards organization and its representative in the European CEN and the international ISO and IEC. With nearly 6,000 experts organized into over 350 groups, ON presides over nearly 23,000 standards. Standards from AS+ are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: [email protected] or 1-212-642-4980 or Request Proposal Price.
Below are AS+'s best-selling standards. To find additional standards, please use the search bar above.
OVE EN 60204-1:2019
Safety of machinery - Electrical equipment of machines -- Part 1: General requirements (IEC 60204-1:2016, modified) (english version)
This part of IEC 60204 applies to electrical, electronic and programmable electronic equipment and systems for machines that are not carried by hand while working, including a group of machines that work in concert. The equipment covered by this part of IEC 60204 starts at the mains connection point of the electrical equipment of the machine (see 5.1). This part of IEC 60204 applies to electrical equipment or parts of electrical equipment that operate at rated voltages up to and including AC 1 000 V or up to and including DC 1 500 V and rated frequencies up to and including 200 Hz.
ONORM EN ISO 19011:2018
Guidelines for auditing management systems (ISO 19011:2018)
This document provides a guide to the audit of management systems, including the Auditprinzipien, the control of audit program and the conduct of audits of management systems, as well as to assess the competence of those in the applicable are included. These activities relate to the person (s) that controls the audit programme (tax), auditors, and audit. It is applicable to all organizations that need to plan internal or external audits of management systems and perform or control an audit programme. The application of this document to other types of audits is possible, provided, special attention is attached to the special expertise required.
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OVE EN 50155:2018
Railway applications - Rolling stock - Electronic equipment (english version)
This European Standard applies to all electronic equipment for control, regulation, protection, diagnostics, energy supply, etc., installed on rail vehicles.áAn electronic equipment within the meaning of this European Standard is defined as a resource that is mainly composed of semiconductor devices and commonly associated components.áThese components are mainly mounted on circuit boards.áSensors (current, voltage, speed, etc.) and power semiconductor (SDU) control units for power electronic devices are covered by this standard.áComplete control units for power semiconductors (SDU) and power converters are included in EN 61287-1.áThis European Standard covers the operating conditions, the design requirements,áthe documentation and testing of the electronic equipment as well as the basic hardware and software requirements deemed necessary for a powerful, reliable resource.áSpecial requirements regarding measures to ensure defined levels of functional safety are ensured in accordance with the relevant safety standards for railways.áThe requirements for the software for the equipment on rolling stock are specified in EN 50657.áSpecial requirements regarding measures to ensure defined levels of functional safety are ensured in accordance with the relevant safety standards for railways.áThe requirements for the software for the equipment on rolling stock are specified in EN 50657.áSpecial requirements regarding measures to ensure defined levels of functional safety are ensured in accordance with the relevant safety standards for railways.áThe requirements for the software for the equipment on rolling stock are specified in EN 50657.
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ONORM EN ISO 11607-2:2022
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)
This document determines requirements for the development and validation of packaging processes for medical devices that are sterilized in the final packaging. These methods include shaping, sealing and compiling ready-made sterile barrier systems, sterile barrier systems and packaging systems. It applies to industry, health care facilities and for all other facilities in which medical devices are packed and sterilized. It does not cover all the requirements for packaging aseptically produced medical devices. Additional requirements may be required for combinations of medication and medical devices.
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ONORM EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
This document lays down the general criteria for testing the sterility of medical devices undergoing sterilising treatment, which has been reduced compared to that expected to be used in routine sterilization procedures. These tests are provided for when a sterilisation process is defined, validated or maintained. This document shall not apply to: (a) the sterility test for the routine release of a product that has undergone a sterilisation procedure; (b) carrying out a sterility test; (c) checking sterility or testing for sterility to demonstrate the shelf life and stability of the product and/or the integrity of the packaging; and (d) the cultivation of biological indicators or infused products.
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ONORM EN ISO 14644-2:2016
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015) (Austrian Standard)
This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration. This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 ªm to 5 ªm. Concentrations of ultrafine particles (particles smaller than 0,1ªm) are addressed in ISO 14644-12.
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ONORM EN ISO 14644-4:2023
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)
This document determines the process of creating a clean room from the requirements for planning and execution to initial commissioning. It can be used for new, modernized or converted clean room systems. It does not prescribe any specific technical or contractual measures to achieve these requirements. It is intended for users, project managers, planners, clients, suppliers, builders and performance auditors of clean room systems. The most important aspect of clean rooms is the concentration of the air -borne particles. For the requirements, the planning, execution and initial commissioning, detailed test subjects are given, the performance parameters to be taken into account. Planning approaches regarding energy management to support energy -efficient clean room planning are determined. Instructions for execution including the requirements for initial commissioning and verification are given. A fundamental part of this document is to consider the aspects (including maintenance) that will help ensure continuous and satisfactory operation throughout the use of the clean room. The following topics are addressed in this document, but not dealt with: - Special operational activities, processes and process facilities to be integrated in the clean room system; - Fire protection and safety regulations; - Ongoing operating, cleaning and maintenance activities dealt with in ISO 14644-5.
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ONORM EN ISO 22301:2020
Security and resilience - Business continuity management systems - Requirements (ISO 22301:2019)
This document lays down requirements to implement, maintain and improve a management system to protect against disruptions, reduce the likelihood of their occurrence, prepare for them, respond to them and recover from them whenever they occur. The requirements set out in this document are of a general nature and are intended to apply to all organisations or parts of them, regardless of their nature, size or nature. The scope of application of these requirements depends on the operational environment and complexity of each organization. This document applies to all types and sizes of organisations wishing to: (a) implement, maintain and improve a BCMS; (b) to ensure consistency with the declared policy of maintaining operational capability; (c) need the ability to supply products and services ...
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ONORM EN ISO 80601-2-61:2019
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, corrected version 2018-02)
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT and the EMERGENCY MEDICAL SERVICES ENVIRONMENT. This document is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. This document can also be applied to ME EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This document is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the PATIENT ENVIRONMENT. This document is applicable to PULSE OXIMETER EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply PULSE OXIMETER EQUIPMENT for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.
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OVE/ONORM EN ISO 14971:2022
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated version)
This document determines terminology, principles and a process for risk management of medical devices, enclosed software as a medical device and in-vitro diagnostics. The process described in this document serves to support manufacturers of medical devices, to identify the risk associated with the medical device, to assess and evaluate the associated risks, to master these risks and to monitor the effectiveness of measures to undermine risk. The requirements of this document are to be applied for all phases of the life cycle of a medical device. The process described in this document is to be applied to risks in connection with a medical device, such as risks regarding biocompatibility, data and system security, electricity, moving parts, radiation and usability. The process described in this document can also be applied to products that are not necessarily considered medical devices in some areas of responsibility and it can also be used by others involved in the life cycle of a medical device. This document cannot be applied for: - Decisions on the application of a medical device in connection with a specific clinical procedure; Or - management of business risks. This document requires manufacturers to determine objective criteria for the acceptance of risk, but it does not determine any acceptable risk areas. Risk management can be part of a quality management system. However, this document does not require that the manufacturer has a quality management system.
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