Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in
vitro methods
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…
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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…
Cardiac pacemakers - Part 1: Implantable pacemakers
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…
Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system fo...
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…
Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable
pacemakers
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…
Petroleum products and lubricants — Determination of rust-prevention characteristics of lubricating ...
This International Standard specifies a method for the determination of the rust-prevention characteristics of lubricating grease in the presence of an aqueous test fluid.
Cinematography — Care and preservation of magnetic audio recordings for motion pictures and televisi...
This International Standard recommends storage conditions for stabilization and preservation of magnetic audio recordings for motion-picture and television production.
It recommends the desirable storage conditions for magnetic audio recordings, as they may remain in library or vault storage between periods of intermittent reproduction or duplication.
It describes the care and handling of…
Vehicles, motorboats and spark-ignited engine-driven devices - Radio disturbance characteristics - L...
Applies to the emission of broadband and narrowband electromagnetic energy which may cause interference to radio reception and which is emitted from: a) vehicles propelled by an internal combustion engine, electrical means, or both; b) motor boats propelled by an internal combustion engine, electrical means, or both; c) devices equipped with spark-ignited internal combustion engines. This…
Biological evaluation of medical devices - Part 2: Animal welfare requirements
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…
Gas-Fired, Work Activated Air-Conditioning and Heat Pump Appliances (Internal Combustion)
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…