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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.
NBN - EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT Organization: NBN
Date: 2009-12-16
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.
NBN - EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT Organization: NBN
Date: 2009-12-16
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.
NBN - EN 738-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT Organization: NBN
Date: 1998-12-09
Description: 1.1 This European 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. 1.2 This European Standard does not apply to pressure regulators supplied as spare parts for a specific application. 1.3 This European Standard does not apply to pressure regulators for use with suction services (see EN ISO 10079-3).
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 regulators suitable for inlet pressures between 280 kPa and 600 kPa supplied and packaged as for use in medical equipment intented for the anministration of medical gases in the treatment, manegement, diagnostic evalation and care of parients for use with the following medical gases:oxygen, nitrous oxide, air for breathing, helium, carbon dioxcide, xenon, specified mixtures of the gases listed 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.
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.
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.
ISO 17664 - STERILIZATION OF MEDICAL DEVICES INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES - FIRST EDITION Organization: ISO
Date: 2004-03-01
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.
DS/EN 13795-1 - 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: 2002-12-20
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.
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.

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