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DS/EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT Organization: DS
Date: 2009-11-04
Description: This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.
SNV - SN EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT Organization: SNV
Date: 2010-03-01
Description: This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.
DS/EN 738-4/A1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT Organization: DS
Date: 2002-06-12
Description: This standard applies to low-pressure regulators suitable for inlet pressures between 280 kPa and 600 kPa, supplied and packaged as for use in medical equipment intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: Oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; N0/N2 mixtures (N0 <= 1000 µl/l).
DS/EN 738-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT Organization: DS
Date: 1999-02-02
Description: This part of the standard applies to low-pressure regulators suitable for inlet pressures between 280 kPa and 600 kPa, supplied and packaged as for use in medical equipment intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: Oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above.
TSE - TS EN 738-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT Organization: TSE
Date: 2003-04-30
Description: This European standard applies to low-pressure regulatorssuitable for inlet pressures between 280 kPa and 600 kPa suppliedand packaged as for use in medical equipment intented for theanministration of medical gases in the treatment, manegement,diagnostic evalation and care of parients for use with thefollowing medical gases:oxygen, nitrous oxide, air for breathing,helium, carbon dioxcide, xenon, specified mixtures of the gaseslisted above
CSA Z314.22 - MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES - THIRD EDITION Organization: CSA
Date: 2016-01-01
Description:   This Standard does not address: a) decontamination of reusable medical devices (see CSA Z314.8); b) sterilization of medical devices (see CSA Z314.3 and CSA Z314.23); c) packaging of medical devices (see CSA Z314.14); d) storage of medical devices (see CSA Z314.15); e) single-use medical devices that accompany loaned, reusable medical devices; and f) non-critical equipment (e.g., light source) accompanying critical and semi critical devices.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: ., human factors engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers); c) Medical researchers and other interested clinicians; and d) Marketers and other business professionals in the medical device industry.
MODUK - DEF STAN 81-41: PART 1 - PACKAGING OF DEFENCE MATERIEL PART: 1 : INTRODUCTION TO DEFENCE PACKAGING REQUIREMENTS - ISSUE 9: 12/2016 Organization: MODUK
Date: 2016-12-14
Description: This Part of the Defence Standard provides the package designer with information about the MOD requirement for packaging items of equipment and spares, defines the various types and levels of packaging used and outlines the requirements for packaging premises, transport, handling and storage Defence Standard 81-041 (Part 1) does not apply to the packaging of ammunition and explosives except when used in conjunction with Def Stan 00-088 Packaging of Ammunition and Explosives and Def Stan 00-810 Marking of Ammunition and Explosives and related standards.
DS/EN 50332-1 - SOUND SYSTEM EQUIPMENT: HEADPHONES AND EARPHONES ASSOCIATED WITH PERSONAL MUSIC PLAYERS - MAXIMUM SOUND PRESSURE LEVEL MEASUREMENT METHODOLOGY - PART 1: GENERAL METHOD FOR "ONE PACKAGE EQUIPMENT" Organization: DS
Date: 2013-11-12
Description: .¿ And finally, it is desirable to establish a global measuring procedure, including each component in the chain:Portable set + specific test signal + associated headphone or earphone.The standard is split into two parts:¿ Part 1 deals with sets provided as a package equipment by the manufacturer. In this case, "Personal music players" means the association of one set (compact cassette player, FM radio receiver, digital media player, streaming audio player...) with supplied headphones or earphones.¿ Part 2 gives guidelines to associate portable audio sets (FM radio receiver, digital media player, streaming audio player...) with headphones or earphones provided separately by any source.
CENELEC - EN 50332-1 - SOUND SYSTEM EQUIPMENT: HEADPHONES AND EARPHONES ASSOCIATED WITH PERSONAL MUSIC PLAYERS - MAXIMUM SOUND PRESSURE LEVEL MEASUREMENT METHODOLOGY - PART 1: GENERAL METHOD FOR "ONE PACKAGE EQUIPMENT" Organization: CENELEC
Date: 2013-10-01
Description: The standard is split into two parts: − Part 1 deals with sets provided as a package equipment by the manufacturer. In this case, "Personal music players" means the association of one set (compact cassette player, FM radio receiver, digital media player, streaming audio player...) with supplied headphones or earphones.
CSA Z314.23 - CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS - SECOND EDITION Organization: CSA
Date: 2016-01-01
Description: This Standard includes chemical sterilization specific requirements for a) work areas and equipment; b) preparation and packaging of medical devices; c) sterilizer loading, unloading, and operation; d) procedures that might be required following sterilization, to minimize sterilant residuals; e) sterility assurance, including process challenge device (PCD) and use; f) sterilizer maintenance and quality assurance; and g) occupational health and safety (OHS) issues specifically related to chemical sterilization systems.
CSA Z17664 - STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES - FIRST EDITION Organization: CSA
Date: 2006-01-01
Description: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.
AAMI ST81 - STERILIZATION OF MEDICAL DEVICES-INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES Organization: AAMI
Date: 2004-01-01
Description: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor.
DSF/EN 13795-1/PRA1 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS Organization: DS
Description: This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures.
DS/EN 13795-1 + A1 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS Organization: DS
Date: 2009-10-06
Description: Requirements for medical gloves are given in the EN 455 series of European Standards and packaging materials are covered by the EN 868 series.
ASTM F3127 - STANDARD GUIDE FOR VALIDATING CLEANING PROCESSES USED DURING THE MANUFACTURE OF MEDICAL DEVICES Organization: ASTM
Date: 2016-04-01
Description: Inclusions: This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging. Exclusions: Reusable medical devices.
DS/EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS Organization: DS
Date: 2014-06-18
Description: This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
ASTM F2020 - STANDARD PRACTICE FOR DESIGN, CONSTRUCTION, AND PROCUREMENT OF EMERGENCY MEDICAL SERVICES SYSTEMS (EMSS) AMBULANCES Organization: ASTM
Date: 2002-10-10
Description: Transporting essential personnel and equipment to and from the site of a multiple medical emergency or a triage site and transporting appropriately triaged patients to designated medical facilities.
DIN EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS Organization: DIN
Date: 2014-08-01
Description: This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: — the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; — the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
DS/EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: DS
Date: 2014-09-12
Description: They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.

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