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TSE - TS 13071 - WORK PLACES-SALE AND SERVICE PLACES FOR GAS WITH CYLINDERS - GENERAL RULES Organization: TSE
Date: 2004-03-02
Description: This standard includes, general rules for management, physical characteristics, technical equipment and personnel of competent services for sele and services places of LPG, acetylen, industries oxygen, hydrogen, medical oxgyen, narcosis, dried air and special gases used in laboratory and calibration process and mixtures of these in the state of cryogenic gas, continuously gas, liqueded gas under pressure saled in the cylenders the water capasity of that up to 300 litres (300 litres include) and cylinders palettes.
JSA - JIS T 7208-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS Organization: JSA
Date: 2012-03-01
Description: ISO 10079-1: 1999 Medical suction equipment-Part 1: Electrically powered suction equipment-Safety requirements (MOD) In addition, symbols, which denote the degree of correspondence in the contents between the relevant International Standard and JIS, are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/lEC Guide 21-1.
IEC 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT – PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE – COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT - EDITION 2.0 Organization: IEC
Date: 2015-01-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
IEC 60601-1-11 REDLINE - MEDICAL ELECTRICAL EQUIPMENT – PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE – COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT - EDITION 2.0 Organization: IEC
Date: 2015-01-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
CEI - EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT Organization: CEI
Date: 2016-01-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
AAMI HA60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT - FDA RECOGNIZED Organization: AAMI
Date: 2015-01-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
CENELEC - EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT Organization: CENELEC
Date: 2015-05-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
DS/EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT Organization: DS
Date: 2015-06-04
Description: IEC 60601-1-11:201 5 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.
DS/EN 62464-1 - MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS Organization: DS
Date: 2007-06-26
Description: This international standard specifies measurement procedures for the determination of many essential medical MR EQUIPMENT image quality parameters. Measurement procedures as addressed in this standard are suitable for:- quality assessment in the ACCEPTANCE TEST;- quality assurance in the CONSTANCY TEST.
IEEE 139 - RECOMMENDED PRACTICE FOR THE MEASUREMENT OF RADIO FREQUENCY EMISSION FROM INDUSTRIAL, SCIENTIFIC, AND MEDICAL (ISM) EQUIPMENT INSTALLED ON USER'S PREMISES Organization: IEEE
Date: 1988-06-09
Description: This document describes equipment inspection and radio frequency (rf) electromagnetic field measurement procedures for evaluation of rf industrial, scientific, and medical (ISM) equipment installed in the user's facility. The term, "ISM equipment," as used here, includes equipment that generates rf energy for purposes other than radio communications, to cause physical, chemical, or biological changes; for example, industrial heaters (dielectric and induction), medical diathermy, ultrasonic equipment, rf plasma devices, and rf stabilized welders.
DS/EN 60601-2-1 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV Organization: DS
Date: 2016-08-25
Description: Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment.
ISO 25424 - STERILIZATION OF MEDICAL DEVICES — LOW TEMPERATURE STEAM AND FORMALDEHYDE — REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - FIRST EDITION Organization: ISO
Date: 2009-09-01
Description: This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
CEN - EN ISO 25424 - STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: CEN
Date: 2011-06-01
Description: This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
SNV - SN EN ISO 25424 - STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: SNV
Date: 2011-09-01
Description: This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
IEC 60364-7-710 - ELECTRICAL INSTALLATIONS OF BUILDINGS PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS MEDICAL LOCATIONS - EDITION 1.0 Organization: IEC
Date: 2002-11-01
Description: The requirements of this part do not apply to medical electrical equipment.NOTE 3 For medical electrical equipment, refer to the IEC 60601 series.
DS/HD 60364-7-710 - LOW-VOLTAGE ELECTRICAL INSTALLATIONS – PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS – MEDICAL LOCATIONS Organization: DS
Date: 2015-09-10
Description: These requirements, in the main, refer to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place. The requirements of this part do not apply to ME equipment. This part also applies to electrical installations in locations designed for medical research.
AAMI RD62 - WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS - FDA RECOGNIZED; INCORPORATES AMENDMENT 1: 2009 Organization: AAMI
Date: 2006-01-01
Description: The physician in charge of dialysis also is responsible for maintaining the performance of that system after control of the system has been transferred formally from the installer to the physician. Generally, this transfer takes place after the installer of the system has demonstrated that the performance of the system meets the requirements of this standard.
DS/EN ISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: DS
Date: 2009-10-26
Description: NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products. 1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 1.1.3 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4 This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.
ISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - SECOND EDITION Organization: ISO
Date: 2009-10-15
Description: This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
AAMI 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2009-01-01
Description: This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.

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