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CGA/GAS - CGA M-16 - GUIDANCE FOR ELECTRONIC RECORDS & SIGNATURES IN THE U.S. & CANADIAN FOOD, DRUG, & MEDICAL DEVICE GAS & GAS EQUIPMENT INDUSTRY - FIRST EDITION Organization: CGA/GAS
Date: 2016-01-01
CSA Z314.0 - MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS - FIRST EDITION; INCORPORATED ERRATA: MARCH 2014 Organization: CSA
Date: 2013-03-01
Description: This Standard does not apply to a) single-use/disposable medical devices; and Note: Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such medical devices is found in such publications as the Canadian Healthcare Association (1996), ECRI Institute (1997), and the Canadian Agency for Drugs and Technologies in Health (CADTH 2011).
CSA Z314.23 - CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS - SECOND EDITION Organization: CSA
Date: 2016-01-01
Description: j) inactivation of chemically resistant parasites and protozoa; k) single-use/disposable medical devices; and l) medical devices that have been used with patients who are known or suspected to have prionrelated diseases (e.g., Creutzfeldt-Jakob Disease).
CSA ISO 11135 - MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION - FIRST EDITION; SUPERSEDES CAN/CSA-Z214.5: 1988 Organization: CSA
Date: 1998-03-01
Description: It supersedes CSA Standard CAN/CSA-Z314.5-88, Industrial Sterilization of Medical Devices by the Ethylene Oxide Process. This Standard is intended to provide guidance for companies in determining minimum requirements for a program of sterility assurance.
CSA Z11135-1 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - FIRST EDITION Organization: CSA
Date: 2009-01-01
Description: Preface This is the first edition of CAN/CSA-Z11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 11135-1 (first edition, 2007-05-01).
DS/ISO/TR 18112 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR PROFESSIONAL USE - SUMMARY OF REGULATORY REQUIREMENTS FOR INFORMATION SUPPLIED BY THE MANUFACTURER Organization: DS
Date: 2006-02-23
Description: This Technical Report summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.
CGA/GAS - CGA C-9 - STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE - FIFTH EDITION Organization: CGA/GAS
Date: 2013-01-01
Description: This standard does not apply to the following: – containers for delivery to foreign countries or to United States military agencies that have established color marking standards that differ from this standard; – containers used in hospitals or other medical institutions for purposes other than medical use; – containers used in industrial applications; – nonportable storage vessels; – containers that are attached to and form a part of any over-the-highway vehicle; – containers when the contents are classified as medical devices or to supplementary medical equipment used with these containers, for example gases or gas mixtures specifically intended for use in calibrating medical equipment; – containers that are filled from home fill oxygen concentrator systems; and – containers that are filled from home fill liquid oxygen systems.
UL 61010-2-040 - UL STANDARD FOR SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE – PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS - SECOND EDITION Organization: UL
Date: 2016-01-15
Description: Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.
CSA C22.2 NO 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY - SECOND EDITION Organization: CSA
Date: 2015-01-01
Description: This Standard covers ME Equipment that is intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
CGSB - CAN/CGSB-106.5-95 - BLOOD GROUPING AND ANTI-HUMAN GLOBULIN REAGENTS Organization: CGSB
Date: 1995-06-01
Description: Consumers' complaints regarding reagents may be directed to the Bureau of Medical Devices, Environmental Health Directorate, Health Canada, Block 1600, Main Statistics Building, Tunney's Pasture, Ottawa, Ontario, K1 A OL2.
CSA Z314.3 - EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS - SIXTH EDITION; INCORPORATES ERTA: JANUARY 2015 Organization: CSA
Date: 2014-01-01
Description: e) single-use/disposable medical devices; or Note: See the Canadian Healthcare Association, the ECRI Institute, and the Canadian Agency for Drugs and Technologies in Health.
CSA Z314.2 - EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS - FIFTH EDITION; UPDATE NO 1: JANUARY 2010; UPDATE NO 2: JULY 2010 Organization: CSA
Date: 2009-03-01
Description: This Standard includes requirements for (a) policies, procedures, and documentation; (b) personnel qualifications and training; (c) quality system; (d) evaluation and purchase of reusable medical devices; (e) work areas and equipment; (f) preparation and packaging of medical devices requiring sterilization; (g) sterilizer loading and operation; (h) aeration following sterilization; (i) storage of sterilized medical devices; (j) sterility assurance, including process challenge device (PCD) construction and use; and (k) maintenance and sterilizer quality assurance.
CSA Z32 - ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES - FOURTH EDITION Organization: CSA
Date: 2015-01-01
Description: Relationship to the Canadian Electrical Code Provisions of this Standard are supplementary to the installation requirements specified in Sections 24 and 52 of the Canadian Electrical Code, Part I and require compliance with Canadian Electrical Code, Part II standards.
CSA C22.2 NO 114 - DIAGNOSTIC IMAGING AND RADIATION THERAPY EQUIPMENT - THIRD EDITION; GENERAL INSTRUCTION NO 1 Organization: CSA
Date: 1990-05-01
Description: This Standard applies to diagnostic imaging and radiation therapy equipment designed to be (a) installed and used in accordance with the Canadian Electrical Code, Part I while connected to supply circuits with nominal system voltages of 750 V and less; and (b) battery powered, insofar as the requirements are applicable.
CSA Z900.1 - CELLS, TISSUES, AND ORGANS FOR TRANSPLANTATION: GENERAL REQUIREMENTS - SECOND EDITION; UPDATE 1: APRIL 2013 Organization: CSA
Date: 2012-12-01
Description: Two specific topics covered by this Standard that are not within the current scope of Health Canada's Safety of Human Cells, Tissues and Organs for Transplantation Regulations are (a) tissues such as heart valves and dura mater, which are classified by Health Canada as a medical device and are subject to the requirements of the Medical Devices Regulations.
CSA C22.2 NO 227.3 - MECHANICAL PROTECTION TUBING (MPT) AND FITTINGS - FOURTH EDITION Organization: CSA
Date: 2015-01-01
Description: The MPT, fittings, and clamps are intended to be used to interconnect separate component assemblies or consoles of electrical devices, such as robotics, medical or X-ray equipment. The mechanical protection afforded the internal wiring contained within the tubing is considered equivalent to the protection provided by a type SJT flexible cord.
UL 1696 - UL STANDARD FOR SAFETY MECHANICAL PROTECTION TUBING (MPT) AND FITTINGS - SECOND EDITION Organization: UL
Date: 2015-01-09
Description: The MPT, fittings, and clamps are intended to be used to interconnect separate component assemblies or consoles of electrical devices, such as robotics, medical or X-ray equipment. The mechanical protection afforded the internal wiring contained within the tubing is considered equivalent to the protection provided by a type SJT flexible cord.
CSA SPE-1000 - MODEL CODE FOR THE FIELD EVALUATION OF ELECTRICAL EQUIPMENT - FOURTH EDITION Organization: CSA
Date: 2013-05-01
Description: This Model Code does not apply to the field evaluation of a) wire and cable products; b) wiring devices; c) equipment for use in hazardous locations; d) medical electrical equipment and systems; e) components* that will require further evaluation as part of a complete assembly, such as switches, relays, and timers; f) equipment connected to line voltage in excess of 46 kV; g) manlifts, elevators, climb assists and similar systems (other than their associated control panels); and h) any equipment that is not permitted to be field evaluated as directed by an AHJ (such as air-cleaning equipment that intentionally produces ozone).
UL 61010A-2-010 - UL STANDARD FOR SAFETY ELECTRICAL EQUIPMENT FOR LABORATORY USE; PART 2: PARTICULAR REQUIREMENTS FOR LABORATORY EQUIPMENT FOR THE HEATING OF MATERIALS - FIRST EDITION Organization: UL
Date: 2002-03-13
Description: This standard applies to equipment to be employed in accordance with ANSI/NFPA 70, National Electrical Code® (NEC); designed to be installed in accordance with the Canadian Electrical Code (CEC), Part I, CSA C22.1, and CSA C22.2 No. 0; or designed to comply with both the NEC and CEC.
SNZ AS/NZS 62841.3.1 - ELECTRIC MOTOR-OPERATED HAND-HELD TOOLS, TRANSPORTABLE TOOLS AND LAWN AND GARDEN MACHINERY – SAFETY – PART 3.1: PARTICULAR REQUIREMENTS FOR TRANSPORTABLE TABLE SAWS Organization: SNZ
Date: 2015-06-30
Description: NOTE 6 In Canada, the following conditions apply: This standard deals with tools used in non-hazardous locations in accordance with the Canadian Electric Code, Part 1, CSA C22.1, and General Requirements – Canadian Electrical Code, Part II, CAN/CSA-C22.2 No. 0.

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