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.
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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.
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.
ONORM EN ISO 11607-2:2020
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
This document lays down requirements for the development and validation of packaging processes for medical devices that are sterilized in the final packaging. These processes include the forming, sealing and assembly of prefabricated sterile barrier systems, sterile barrier systems and packaging systems. It applies to industry, healthcare facilities and all other facilities where medical devices are packaged and sterilised. It does not cover all requirements for packaging of aseptically manufactured medical devices. Combinations of medicines and medical devices may require additional requirements.
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.
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.
ONORM EN ISO 14644-4:2001
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) (Austrian Standard)
This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.
Application of this part of ISO 14644 is restricted in the following:
- user requirements are represented by purchaser or specifier;
- specific processes to be accommodated in the cleanroom installation are not specified;
- fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;
- process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
- regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.
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 ...
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.
OVE/ONORM EN ISO 14971:2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
This document defines terminology, principles, and a process for the risk management of medical devices, including software as a medical device and in vitro diagnostics. The process described in this document is designed to help medical device manufacturers identify the risks associated with the medical device, assess and assess the risks involved, manage those risks, and monitor the effectiveness of risk management measures. The requirements of this document apply to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as biocompatibility risks, data and system security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are used in some areas of responsibility .
