Rechercher

This National Standard of Canada is equivalent to International Standard ISO 10993-3:1992. 1 Scope This part of ISO 10993 specifies tests for the following biological aspects: - genotoxicity, - carcinogenicity, and - reproductive and developmental toxicity. These are relevant in the biological evaluation of some categories of medical devices (see note 1). Guidance on selection…

This National Standard of Canada is equivalent to International Standard ISO 10993-4:1992. 1 Scope This part of ISO 10993 gives guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical and dental devices that are intended for use in contact with blood, based…

This National Standard of Canada is equivalent to International Standard ISO 10993-5:1992. 1 Scope This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. NOTE 1 The term medical devices corresponds to the definition given in ISo 10993-1 and covers medical materials as well as dental material and devices. The definition is in accordance…

This National Standard of Canada is equivalent to International Standard ISO 10993-6:1994. 1 Scope This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the…

This National Standard of Canada is equivalent to International Standard ISO 5841-1:1989. 1 Scope and field of application 1.1 This part of ISO 5841 establishes basic terminology and definitions, and specifies requirements for marking implantable cardiac pacemakers and their packaging. Minimum requirements for the ability of pacemaker pulse generators to withstand environmental…

This National Standard of Canada is equivalent to International Standard ISo 10012-1:1992. 1 Scope 1.1 This part of ISO 10012 contains quality assurance requirements for a Supplier to ensure that measurements are made with the intended accuracy. It also contains guidance on the implementation of the requirements. 1.2 This part of ISO 10012 specifies the main features of the…

This National Standard of Canada is equivalent to International Standard ISO 5841-3:1992. 1 Scope This part of ISO 5841 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements are specified together with appropriate test methods. Other connector features such as…

This National Standard of Canada is equivalent to International Standard ISO 10993-2:1992. 1 Scope This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended a) to establish guidelines which allow the scientist to respect life in general; b) to reduce the number of animal experiments and the number…

1.1 SCOPE 1.1.1 This standard applies to newly produced, gas-fired, work activated, air conditioning and heat pumping appliances, hereinafter referred to as appliances, constructed entirely of new, unused parts and materials, which are designed to supply conditioned air; heated and/or cooled liquid; or refrigerants, gases, solids, or liquids to spaces remote from or adjacent to the…

This National Standard of Canada is equivalent to International Standard ISO/IEC 10164-11:1994. 1 Scope This Recommendation | International Standard defines the metric objects and attributes function. The metric objects and attributes function is a systems management function which may be used by an application process in a centralised or decentralised management environment to…