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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 Z314.8 - DECONTAMINATION OF REUSABLE MEDICAL DEVICES - FOURTH EDITION Organization: CSA
Date: 2014-01-01
Description:   This Standard includes requirements for a) decontamination areas and equipment; b) immediate handling of contaminated medical devices at the point of use; c) transport of contaminated medical devices; and d) decontamination policies and procedures (in general, as related to reusable diagnostic and therapeutic medical devices, and specifically, as related to reusable respiratory/anaesthesia devices, flexible fibre optic endoscopes, ultrasound transducer probes, and electronic patient-applied devices).
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).
CRC - NE11545 - MEDICAL DEVICE REGULATORY PRACTICES : AN INTERNATIONAL PERSPECTIVE Organization: CRC
Date: 2015-08-03
Description: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies.
CRC - KE15972 - DESIGN CONTROLS FOR THE MEDICAL DEVICE INDUSTRY, SECOND EDITION Organization: CRC
Date: 2013-11-12
Description: The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.
CSA PLUS 9001MD - ISO 9000 AND 13485 ESSENTIALS FOR MEDICAL DEVICE MANUFACTURERS - 2ND EDITION Organization: CSA
Date: 1998-02-01
Description: Quality System Requirements) contains the actual text of IS0 9001:94 and ISO 13485196 guidance made up of excerpts from CAN/CSA-ISO 9000-1-94, CAN/CSAQ 10001-94, and ISO 9000-2:97; from the Global Harmonization Task Force guidance; fiom the ISO/FDIS 14969:97 draft guidance prepared by IS0 Technical Committee 210; and from guidance developed by the Medical Devices Bureau of Canada. definitions from the vocabulary CAN/CSA-ISO 8402-94, and from IS0 13485:96 (which are specific for medical devices) typical self-diagnostic and audit questions where applicable, interpretations provided by the CSA Technical Committee on Quality Management The standard ISO 9000-2:97 issued on June 15,1997, is an update of ISO 9000-2:1993 and is based on the 1994 edition of ISO 9001 and 9002.
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 Z10524 - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES FOR MEDICAL GAS SYSTEMS - FIRST EDITION Organization: CSA
Date: 2002-03-01
Description: CSA Preface This is the first edition of CSA Standard CAN/CSA-Z10524, Pressure regulators and pressure regulators with flow-metering devices for medical gas systems, which is an adoption, with Canadian deviations, of the identically titled I S 0 (International Organization for Standardization) Standard 10524 (first edition, 1995-1 2-01), including Technical Corrigendum 1 :1996.
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.
CSA PLUS 13485 - THE ISO 13485 ESSENTIALS A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 13485 STANDARD FOR MANUFACTURERS OF MEDICAL DEVICES Organization: CSA
Date: 2006-02-01
Description: Preface The primary objective of this Handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 13485 as it relates to their quality management system (QMS). The Canadian National Standard CAN/CSA-ISO 13485:03 is identical to its international counterpart, ISO 13485:03.
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.
CRC - KE38255 - INTRODUCTION TO BIOMEDICAL ENGINEERING TECHNOLOGY, THIRD EDITION Organization: CRC
Date: 2016-09-19
Description: This new edition provides major revisions to a text that is suitable for the introduction to biomedical engineering technology course offered in a number of technical institutes and colleges in Canada and the US. Each chapter has been thoroughly updated with new photos and illustrations which depict the most modern equipment available in medical technology.
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 - CAN/CSA-Z168.5.1-97 - ANAESTHESIA VENTILATORS - SECOND EDITION; GENERAL INSTRUCTION NO 1; UPDATE NO. 2 Organization: CSA
Date: 1997-03-01
Description: Scope and object This Clause of the General Standard applies except as follows: Replacement: This Standard applies to anaesthesia ventilators as defined in Clause 2.13.5, designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I. Other medical equipment such as devices for monitoring, which can be incorporated in or mounted on anaesthesia ventilators, are not covered by this Standard.
CSA Z168.5.1 - ANAESTHESIA VENTILATORS - SECOND EDITION; GENERAL INSTRUCTION NO 1; UPDATE NO. 2 Organization: CSA
Date: 1997-03-01
Description: Scope and object This Clause of the General Standard applies except as follows: Replacement: This Standard applies to anaesthesia ventilators as defined in Clause 2.13.5, designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I. Other medical equipment such as devices for monitoring, which can be incorporated in or mounted on anaesthesia ventilators, are not covered by this Standard.

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