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VA 11 71 01 - MEDICAL WASHING AND STERILIZING EQUIPMENT Organization: VA
Date: 2011-02-01
Description: DESCRIPTIONS This section specifies Medical Reprocessing and Sterilization Equipment including washer disinfectors, cart washers, ultrasonic cleaners, automated endoscope re-processors, steam sterilizers, ethylene oxide (EtO) sterilizer/aerator combination units, ethylene oxide (EtO) abators, plasma sterilizers, ethylene oxide (EtO) monitoring stations, liquid chemical sterilizers, drying cabinets, detergent dispensing units, water treatment systems, steam guns, and endoscope preprocessing sinks.
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.
NBN - EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS Organization: NBN
Date: 2014-07-25
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.
NBN - EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS Organization: NBN
Date: 2014-07-25
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.
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.
CSA Z314.1 - ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES - FIFTH EDITION Organization: CSA
Date: 2009-01-01
Description: This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that (a) the environment in the sterilizing chamber is effective in sterilizing products; and (b) personnel using the equipment are protected from hazards associated with ethylene oxide. This Standard does not provide requirements for the following: (a) pre- or post-sterilization procedures; (b) machine operators; (c) venting of waste gases used in the sterilization process; and (d) tests to indicate the probability of product sterility.
AAMI TIR20 - PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION - CITED BY FDA AS "RELEVANT GUIDANCE" FOR ANSI/AAMI/ISO 11135: 1994 Organization: AAMI
Date: 2001-01-01
Description: This technical information report (TIR) presents the rationale and approach necessary for the implementation of parametric release for product sterilized by ethylene oxide (EO). Additionally, this report highlights the importance and inter-relationship of other process factors (i.e., load configuration and equipment performance) that ultimately influence EO sterilization reproducibility.
DS/CEN/CR 13903 - GENERAL GUIDANCE ON THE EQUIPMENT USED FOR INHALED NITRIC OXIDE THERAPY Organization: DS
Date: 2001-01-10
Description: This CEN Report gives information on the properties and medical uses of nitric oxide and guidance on medical equipment through which this gas passes before and after administration to the patient.
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: 1.1 Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
AAMI 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2014-01-01
Description: Inclusions This International Standard specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
CEN - 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: CEN
Date: 2014-07-01
Description: Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - SECOND EDITION Organization: ISO
Date: 2014-07-15
Description: Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
DIN 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 (ISO 11135:2014) Organization: DIN
Date: 2014-10-01
Description: Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
SNV - SN 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: SNV
Date: 2014-10-01
Description: Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
VA - FED H-08-1 SEC 15491 - MEDICAL GAS AND VACUUM SYSTEMS Organization: VA
Date: 2005-04-01
Description: DESCRIPTIONCentral Medical Gas and Vacuum Systems: Consisting of oxygen, nitrous oxide, nitrogen, compressed air, vacuum and anesthesia evacuation services; complete, ready for operation, including all necessary piping, fittings, valves, cabinets, station outlets and inlets, rough-ins, ceiling services, gages, alarms including low voltage wiring, nitrogen control panels, cylinder manifolds, air compressors, vacuum pumps, electric motors and starters, receivers, air dryers, filters, pressure regulators, dew point, carbon monoxide monitors and all necessary parts, accessories, connections and equipment. 
CSA Z7396.1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS - THIRD EDITION Organization: CSA
Date: 2012-12-01
Description: This Standard applies to pipeline systems for (a) medical gases or medical gas mixtures, including (i) oxygen USP; (ii) oxygen 93 USP; (iii) medical air USP; (iv) nitrous oxide USP; (v) carbon dioxide USP; (vi) helium USP; (vii) oxygen USP/nitrous oxide USP mixtures; (viii) helium USP/oxygen USP mixtures; and (ix)* other medical gases; (b)* medical support gases, including (i) instrument air; and (ii) nitrogen NF; (c) medical vacuum; and (d) anaesthetic gas scavenging systems (AGSSs).
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

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