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DS/ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE – PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: DS
Date: 2017-06-19
Description: ISO/TR 80002-2:2017 applies to – software used in the quality management system, – software used in production and service provision, and – software used for the monitoring and measurement of requirements.
ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS - FIRST EDITION Organization: ISO
Date: 2017-06-01
Description: This document applies to — software used in the quality management system, — software used in production and service provision, and — software used for the monitoring and measurement of requirements.
AAMI TIR80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: AAMI
Date: 2017-01-01
Description: This document applies to — software used in the quality management system, — software used in production and service provision, and — software used for the monitoring and measurement of requirements.
ASSE/SAFE - ANSI ASSE Z9.9 - PORTABLE VENTILATION SYSTEMS Organization: ASSE/SAFE
Date: 2010-01-01
Description: This Standard establishes minimum requirements for the design, construction, and labeling of portable ventilation equipment and systems. This Standard also establishes fundamental requirements for the application, management, operation, maintenance, performance validation, and testing of portable ventilation equipment and systems to ensure satisfactory performance over their lifetime.
AISC - 420 - CERTIFICATION STANDARD FOR SHOP APPLICATION OF COMPLEX PROTECTIVE COATING SYSTEMS Organization: AISC
Date: 2010-09-23
Description: The requirements of this Standard are applied to the quality management system of a certified Firm independent of individual project requirement for Certification to this Standard.
CENELEC - EN 62974-1 - MONITORING AND MEASURING SYSTEMS USED FOR DATA COLLECTION, GATHERING AND ANALYSIS - PART 1: DEVICE REQUIREMENTS Organization: CENELEC
Date: 2017-07-01
Description: Automatic analysis can include calculation of energy baselines or energy performance indicators as requested for the energy management system required by ISO 50001, or can be used during energy audits as defined in ISO 50002, or can be used for monitoring an installation complying with IEC 60364-8-1.
IEC 62974-1 - MONITORING AND MEASURING SYSTEMS USED FOR DATA COLLECTION, GATHERING AND ANALYSIS - PART 1: DEVICE REQUIREMENTS - EDITION 1.0 Organization: IEC
Date: 2017-05-01
Description: Automatic analysis can include calculation of energy baselines or energy performance indicators as requested for the energy management system required by ISO 50001, or can be used during energy audits as defined in ISO 50002, or can be used for monitoring an installation complying with IEC 60364-8-1.
CSA Z314.14 - SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS - FIFTH EDITION Organization: CSA
Date: 2015-01-01
Description: Note: CSA Z314.0 provides requirements for quality management systems. CSA Z314.3 and CSA Z314.23 provide requirements for steam sterilization and chemical sterilization in healthcare settings.
ASABE S613-4 - TRACTORS AND SELF-PROPELLED MACHINERY FOR AGRICULTURE - AIR QUALITY SYSTEMS FOR CABS - PART 4: PERFORMANCE TEST OF A CAB Organization: ASABE
Date: 2017-08-01
Description: This part of the S613 standard series defines a performance test for a cab for use in a risk management program in contaminated environments as part of an Occupational Health and Safety Management System (OHSMS). This document is intended to be a guide for engineers and field technicians who are responsible for cabs in agricultural applications.
IEEE C57.12.35 - BAR CODING FOR DISTRIBUTION TRANSFORMERS AND STEP-VOLTAGE REGULATORS Organization: IEEE
Date: 2013-08-23
Description: Included herein are requirements for data content, symbology, label layout, print quality, and label life expectancy. This standard assumes the existence of central transformer databases within utility companies so that bar-code labels need only carry basic transformer identification data.
DS/ISO/TS 19930 - GUIDANCE ON ASPECTS OF A RISK-BASED APPROACH TO ASSURING STERILITY OF TERMINALLY STERILIZED, SINGLE-USE HEALTH CARE PRODUCT THAT IS UNABLE TO WITHSTAND PROCESSING TO ACHIEVE MAXIMALLY A STERILITY ASSURANCE LEVEL OF 10-6 Organization: DS
Date: 2017-11-27
Description: NOTE – It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.
ISO TS 19930 - GUIDANCE ON ASPECTS OF A RISK-BASED APPROACH TO ASSURING STERILITY OF TERMINALLY STERILIZED, SINGLE-USE HEALTH CARE PRODUCT THAT IS UNABLE TO WITHSTAND PROCESSING TO ACHIEVE MAXIMALLY A STERILITY ASSURANCE LEVEL OF 10−6 - FIRST EDITION Organization: ISO
Date: 2017-12-01
Description: NOTE It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.
CLSI POCT17 - USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS - VOL 36; NO 4 Organization: CLSI
Date: 2016-03-01
Description: The contents of this white paper represent the opinions of CLSI volunteers, and each organization using blood glucose meters should determine whether it is practicing offlabel use and collaborate with its internal quality and regulatory departments to develop an appropriate plan to manage this off-label use. Alternatively, organizations should be advised to review their management plan with the Centers for Medicare & Medicaid Services and US Food and Drug Administration (FDA) representatives, if necessary.
DESTECH - THARP AND YOUNG ON ICE CR - THARP AND YOUNG ON ICE CREAM: AN ENCYCLOPEDIC GUIDE - 1ST EDITION Organization: DESTECH
Date: 2012-06-15
Description: Besides providing a definitive introduction to the applied science of frozen desserts, the book explains key management concepts from cost-reduction strategies to yield improvement, marketing, and regulatory compliance in formulation and labeling.
DS/CEN/TS 17073 - POSTAL SERVICES – INTERFACES FOR CROSS BORDER PARCELS Organization: DS
Date: 2017-06-26
Description: The interface is composed on two items: - the physical label stuck on the postal item: contents, sizes, minimum requirements to guarantee the quality and efficiency of the logistic process (sorting, delivery)
CEN/TS 17073 - POSTAL SERVICES - INTERFACES FOR CROSS BORDER PARCELS Organization: CEN
Date: 2017-06-01
Description: The interface is composed on two items: — the physical label attached on the postal item: contents, sizes, minimum requirements to guarantee the quality and efficiency of the logistic process (sorting, delivery).
AAMI TIR36 - VALIDATION OF SOFTWARE FOR REGULATED PROCESSES Organization: AAMI
Date: 2007-01-01
Description: Specific training or experience in medical device quality management systems and the regulations governing these systems is recommended.
PACKT - OPENSTACK FOR ARCHITECTS - OPENSTACK FOR ARCHITECTS Organization: PACKT
Date: 2017-02-06
Description: The huge amount of investment from these organizations, industry giants such as IBM and HP, as well as open source leaders such as Red Hat have led analysts to label OpenStack as the most important open source technology since the Linux operating system. Because of its ambitious scope, OpenStack is a complex and fast-evolving open source project that requires a diverse skill-set to design and implement it.
IEC TR 62366-2 - MEDICAL DEVICES – PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES - EDITION 1.0 Organization: IEC
Date: 2016-04-01
Description: This technical report discusses the business benefits of USABILITY ENGINEERING, the basics of applicable analysis and design techniques, MEDICAL DEVICE USABILITY EVALUATION approaches, efficient ways to address USABILITY ENGINEERING project implementation issues (e.g. integration into a quality management system) and provides a list of useful USABILITY ENGINEERING resources.
API RP 970 - CORROSION CONTROL DOCUMENTS - FIRST EDITION Organization: API
Date: 2017-12-01
Description: Section 5 contains key points for establishing a site procedure that documents the CCD work process. NOTE Even though CCDs are labeled “Documents” for the purposes of this RP, it is recognized that much of the suggested content of a CCD may, in fact, reside in separate folders and electronic information storage sites.

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