PDF Price
$248.00
ADD TO CART
Ventilator and breathing apparatuses standards are published by CSA, ASTM, CGA, and ISO, covering various aspects of medical ventilators, oxygen canisters, and other forms of medical devices designed to assist patients’ breathing. A popular standard listed here is CGA G-4.1, cleaning equipment for oxygen service, which governs the sterilization and cleanliness of oxygen distribution systems. These standards are necessary for those working in the medical field.
This publication describes the cleaning methods and requirements for equipment used in the production, storage, distribution, and use of liquid and gaseous oxygen to reduce the risk of fire, explosion, or promotion of combustion. Cleaning in accordance with this publication is required for all surfaces in contact with a gas or liquid that has an oxygen concentration greater than 23.5%. Examples of such equipment include stationary storage tanks, road tankers, and rail cars; pressure vessels such as heat exchangers and distillation columns; compressors and pumps; and associated piping, valves, and instrumentation. However, the cleaning methods and requirements are not limited to this equipment. With modifications, these methods may be used for cleaning other oxygen and oxidizer (e.g., fluorine, nitrogen trifluoride, nitrous oxide) service equipment such as cylinders, cylinder valves, cylinder regulators, welding torches, and pipelines where regulatory requirements do not specify cleaning methods.
Preface This is the sixth edition of CSA Z180.1, Compressed breathing air and systems. It supersedes the previous editions published in 2013, 2000, 1985, 1978, and 1973. Where appropriate, this Standard has been harmonized with other national and international standards dealing with compressed breathing air and systems, e.g., CSA Z275.2. New to this edition is a compliance checklist (Annex F). This checklist is provided in order to assist users in compliance auditing. It highlights the critical requirements of the Standard that should be regularly checked as part of a respiratory protection program (as detailed in CAN/CSA-Z94.4). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 1.1 This Standard provides the minimum requirements, unless otherwise specified by the authority having jurisdiction, for the purity of compressed breathing air supplied to the service outlet and for breathing air systems required to produce, store, and distribute such air. 1.2 This Standard is limited to compressed breathing air and compressed breathing air systems used in the following applications: a) supplied-air respirators; b) supplied-air suits; c) self-contained breathing apparatus (SCBA) (open circuit); d) ambient air systems; and e) other applications for which qualified persons deem it appropriate to reference the compressed breathing air purity requirements described in this Standard, e.g., vortex tubes used for heating and cooling supplied-air suits. Notes: 1) Implementation of the requirements of this Standard within a respiratory protection program is addressed in CAN/CSA-Z94.4. 2) The manufacturer, the applicable testing agency, and the authority having jurisdiction should be consulted for quality requirements for breathing gas in closed-circuit SCBA. 3) For diving operations, refer to CSA Z275.2. 1.3 This Standard includes requirements applicable to the design, construction, commissioning, calibration, testing, operation, and maintenance of components for compressed breathing air systems. 1.4 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.
This document specifies:
— the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;
— the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
— the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).
This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).
This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests.
This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter.
This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction.
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).
This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 (all parts).
This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.
NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds.
This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.
This document is intended to be read in conjunction with ISO 18562-1.
This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.
This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device.
This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.
Preface This is the fifth edition of CSA C439, Laboratory methods of test for rating the performance of heat/ energy-recovery ventilators. It supersedes the previous editions, published in 2009, 2000, 1988, and 1985. This Standard applies to packaged heat/energy-recovery ventilators. CSA acknowledges that the development of this Standard was made possible, in part, by the financial support of Natural Resources Canada (NRCan), BC Hydro, Manitoba Hydro, Ontario Ministry of Energy and Infrastructure, the Canadian Electricity Association, Independent Electricity System Operator (IESO), Nova Scotia Department of Energy, EfficiencyOne, and Sask Power. This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was prepared by the Subcommittee on Methods of Test for Rating the Performance of Heat/Energy-Recovery Ventilators, under the jurisdiction of the Technical Committee on Heating, Ventilation, Air Conditioning, and Refrigeration and the Strategic Steering Committee on Performance, Energy Efficiency, and Renewables, and has been formally approved by the Technical Committee. It will be submitted to the Standards Council of Canada for approval as a National Standard of Canada. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 1.1 1.1.1 This Standard applies to packaged heat/energy-recovery ventilators (HRVs/ERVs) that consist of factory- assembled elements, including fans or blowers, in which heat or heat and moisture are transferred between two isolated airstreams. 1.1.2 This Standard specifies laboratory methods of test and procedures for rating the apparent effectiveness and heat-recovery efficiency of HRVs/ERVs. Procedures for determining air movement capabilities and the leakage of air from one airstream to another are also included. 1.1.3 Packaged HRVs/ERVs that use a refrigeration cycle or circulating fluid to transfer heat between two isolated airstreams may be rated using this Standard. 1.2 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.
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
1.1This practice provides information that is useful for the medical evaluation of respirator users.
1.2This practice does not deal with medical surveillance or biological exposure monitoring. It is understood that since local circumstances vary, no set of guidelines can cover all situations, and specific programs and procedures should be modified for each individual workplace. Medical evaluation is only one element of a complete respiratory protection program. A complete respiratory protection program is defined in Practice F3387.
1.3Units - The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1.1This guide provides guidance on how to conduct fit testing of tight-fitting respirators and appropriate methods to be used. Fit testing is only one element of a complete respiratory protection program. Examples of complete respiratory protection programs are defined in Practice F3387, 29 CFR 1910.134, and so forth.
1.2Purpose - This guide provides requirements for conducting respirator fit testing and includes:
1.2.1Qualifications for fit test operators,
1.2.2Specific fit test methods,
1.2.3Interpretation of fit test results,
1.2.4Recordkeeping, and
1.2.5Methods to validate new fit test methods.
1.3Should and Shall - The provisions of this guide are mandatory in nature when the word "shall" is used and advisory in nature when the word "should" is used.
1.4Units - The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.