Quality systems - Medical devices - Particular requirements for the application
of ISO 9002
This National Standard of Canada is equivalent to International Standard ISO
13488:1996.
1 Scope
This International Standard specifies, in conjunction with IS0 9002, the
quality system requirements for the production and, when relevant, installation
and servicing of medical devices.
This International Standard, in conjunction with ISO 9002, is applicable when
there is a need to…
This National Standard of Canada is based on International Standard CEI/IEC 598-2-19:1981 (first edition, 1981), including Amendments 1:1987, and 2:2002.
Note - Amendment No. 2 reaffirmed 2007-03-28.
19.1 Scope
This section of Part 2 of IEC Publication 598 specifies safety requirements for air-handling luminaires for use with a ventilation duct or ventilated space (plenum), for use with…
This National Standard of Canada is equivalent to International Standard ISO 5840:1996.
1 Scope
1.1 This International Standard specifies tests to be performed and
requirements for test apparatus to be used in determining the physical,
biological and mechanical properties of heart valve substitutes of all types,
and of the materials and components of which they are made.
1.2…
Biological evaluation of medical devices - Part 9: Degradation of materials
related to biological te...
The international community has decided to make this standard available only in
the English language version. It has been adopted as a National Standard of
Canada on this basis.
This National Standard of Canada is equivalent to International Standard ISo
10993-9:1994.
1 Scope
This Technical Report aims to facilitate the design of test procedures which
are used to evaluate the biological…
Biological evaluation of medical devices - Part 1: Guidance on selection of
tests
This National Standard of Canada is equivalent to International Standard ISo
10993-1:1992.
1 Scope
This part of ISO 10993 gives guidance on
a) the fundamental principles governing the biological evaluation of medical
devices;
b) the definition of categories of devices based on the nature and duration of
contact with the body;
c) the selection of appropriate tests.
ISO 10993 does not cover…
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This National Standard of Canada is equivalent to International Standard ISO 10993-12:1996.
1 Scope
This part of ISO 10993 specifies requirements and gives guidance on procedures
to be followed in the preparation of samples of medical devices for testing in
biological systems in accordance with one or more other parts of ISO 10993.
These include:
a) test material selectrion;
b)…
Textiles Test Methods - Textiles - Tests for Colourfastness - Part B01:
Colourfastness to Light: Da...
This National Standard of Canada is equivalent to International Standard ISO
105-B01:1994.
1 Scope
This part of ISO 105 specifies a method intended for determining the resistance
of the colour of textiles of all kinds and in all forms to the action of
daylight.
This method allows the use of two different sets of blue wool references. The
results from the two different sets of…
Textiles Test Methods - Textiles - Tests for Colourfastness - Part B02: Colourfastness to Artificial...
This National Standard of Canada is equivalent to International Standard ISO 105-B02:1994.
1 Scope
This part of ISO 105 specifies a method intended for determining the resistance of the colour of textiles of all kinds and in all forms to the action of an artificial light source representative of natural daylight (D65). The method
is also applicable to white (bleached or optically brightened)…
Performance Packagings for Transportation of Dangerous Goods
1. Scope
1.1 This standard contains design, manufacturing and use requirements for
non-bulk UN specification packagings of no more than 400 kg or 450 l
for the transportation of dangerous goods (other than those classed as
gases, infectious or radioactive).
1.1.1 Part I of this standard applies to classes 1 to 9 excluding classes 2,
6.2 and 7. It…
1 Domaine d'application
1.1 Cette norme s'applique aux tubes électriques non métalliques ondulés (TEN),
ainsi qu'à leurs raccords fixés mécaniquement, destinés à être utilisés dans
des emplacements non dangereux conformément au Code canadien de l'électricité,
Première partie, et à la norme ANSI/NFPA 70, National Electrical Code (NEC).
Ces exigences visent également les…
