1 Scope

1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers radiation processes employing irradiators using:

a) the radionuclide 60Co or 137Cs;

b) a beam from an electron generator; or

c) a beam from an X-ray generator.

1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.

1.2.1 This document does not specify requirements for designating a medical device as sterile.

NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.

1 Scope

1.1 Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.

1.2 Exclusions

1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12).

1.2.2 This document does not address setting specific endotoxin limit specifications.

1 Scope

1.1 Inclusions

1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.

1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.

NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.

1.2 Exclusions

1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document.

NOTE See ISO 14937 for guidance on validation of such processes.

1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information).

1.2.3 This document does not specify requirements for designating a medical device as sterile. NOTE See for example EN 556–1 or ANSI/AAMI ST67.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment.

NOTE For further information on safety, see examples in the Bibliography. National or regional regulations can also exist.

1.2.5 This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle.

1.2.6 This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces.

NOTE These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.

Draft amendment to C22.1

Draft amendment to C22.1

Draft amendment to C22.1

CSA O80.0:21

1 Scope

1.1 Subjects Covered

The CSA O80 Series of Standards specifies requirements related to the preservation and fire retardance of wood through chemical treatment (pressure and thermal impregnation). The subjects covered include materials and their analysis, pressure and thermal impregnation procedures, and fabrication and installation to put treated wood into service.

1.2 Definitions and differences

This Standard lists reference publications and provides definitions applicable to the entire CSA O80 Series of Standards. This Standard also describes how the CSA O80 Series of Standards differs from related AWPA Standards and addresses the need for preservative registration. Recommendations on the use of the CSA O80 Series of Standards and related AWPA Standards can be found in Annex A.

Note: In Canada, preservative registration is carried out through Health Canada’s Pest Management Regulatory Agency.

1.3 Recommendations

The requirements and recommendations of the CSA O80 Series of Standards are based solely on the treatment efficacy of the chemicals in question. The CSA O80 Series of Standards does not necessarily take all laws and regulations into account.

Note: It is the responsibility of the users of the CSA O80 Series of Standards to ensure that their use of preservatives does not conflict with applicable laws and regulations.

1.4 Language

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

CSA O80.1:21

1 Scope

1.1 Intention

This Standard is intended to help specifiers identify appropriate requirements for specific wood products and end use environments.

Note: The existence of a particular requirement in this Standard does not imply that the permitted combination of preservatives, processes, and/or wood species will be recognized by a regulatory body.

1.2 Language

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

CSA O80.2:21

1 Scope

1.1 Requirements

This Standard specifies minimum requirements for treatment of wood products covered by the CSA O80 Series of Standards, including conditioning for treatment, treatment processes and limitations, end results of treatment, post-treatment handling, and quality control. Treatment practices and results should comply with the CSA O80 Series of Standards as a whole and, subject to Clause 4 of CSA O80.0, the relevant AWPA Standards.

1.2 Language

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

CSA O80.3:21

1 Scope

1.1 Specifications

This Standard specifies preservative requirements not referenced elsewhere.

Note: It is intended that this Standard will be used to accommodate additional preservative formulations (if any) in future editions of the CSA O80 Series of Standards.

1.2 Language

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

CSA O80.5:21

1 Scope

1.1 Specifications

This Standard specifies requirements for preparation and use of CCA preservative/additive combinations for utility poles permitted by CSA O80.1 and CSA O80.2.

1.2 Language

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.