201.1 * Scope, object and related standards 

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: 

NOTE   The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 

201.1.1 Scope 
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by: 

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.  

NOTE 1 Conserving equipment can also be used in professional health care facilities. 

This document is also applicable to conserving equipment that is incorporated with other equipment.  

EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. 

This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.  

This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. 

This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).   

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. 

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. 

NOTE 2 Additional information can be found in IEC 60601-:2005+AMD1:2012, 4.2. 

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information see IEC 80601-2-35;
- INFANT INCUBATORS; for information see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information see IEC 60601-2-20;
- INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50.

SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. 

201.1 Scope, object and related standards 

Clause 1 of the general standard1 applies, except as follows: 

201.1.1 Scope 

Replacement: 

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the 
ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4. 

MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as sources of energy being transferred to the PATIENT or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. 

NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard. 

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME EQUIPMENT and to ME SYSTEMS, as relevant. 

Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. 

NOTE 2 See also 4.2, RISK MANAGEMENT process, of the general standard. 

NOTE 3 If the laser equipment is CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. 

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.

This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information see IEC 80601-2-35;
- INFANT INCUBATORS; for information see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information see IEC 60601-2-21.

Scope, objective and related standards

Clause 1 of the general standard1) applies, except as follows:

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ECG ME EQUIPMENT and ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) as defined in 201.3.211, 201.3.240, and 201.3.222, hereinafter also referred to as ECG ME EQUIPMENT. Additional specific requirements apply to the ECG ME EQUIPMENT based on the INTENDED USE claimed by the MANUFACTURER for equipment intended for ECG PATIENT MONITORING, DIAGNOSTIC, or AMBULATORY use as defined in 201.3.226, 201.3.207 and 201.3.202 respectively. This particular standard applies to ECG ME EQUIPMENT for use in professional healthcare facilities as well as in EMERGENCY MEDICAL SERVICE ENVIRONMENTS and HOME HEALTHCARE ENVIRONMENTS.In addition, clauses may be applied to ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) or a part or parts of an ECG system (e.g AMBULATORY ECG RECORDER).

The scope for each of these types of ECG ME EQUIPMENT are described as follows:

ECG ME EQUIPMENT Any ECG device or system or part of a system that acquires an ECG signal from the body surface of one PATIENT and displays, records, analyzes, or transmits the resultant data for the purpose of diagnosing, treating, or monitoring that PATIENT. This includes any device or system or part of a system that meets the definition of MONITORING, DIAGNOSTIC, or AMBULATORY ECG ME EQUIPMENT as well as any other device that acquires and/or processes an ECG signal for the purpose of diagnosing, treating or monitoring a PATIENT based on the acquired body surface ECG signal. This does not include devices that are used for diagnosing, treating or monitoring PATIENTS based only on other types of cardiac signals such as magnetocardiographic signals or derived from other cardiac signals such as heart rate monitors derived from a photo plethysmograph or phonocardiograps. In addition, ECG ME EQUIPMENT does not include devices that are solely used for health and wellness (e.g. fitness trackers measuring heart rate solely to improve general wellness or athletic performance). However, devices that are part of consumer devices (such as a watch) that acquired an ECG and displays, records, analyzes, and/or transmits the ECG for the purpose of diagnosing, treating or monitoring the PATIENT are included in the scope of an ECG ME EQUIPMENT.This does not include external defibrillators unless they have an INTENDED USE for making a diagnosis, monitoring or treatment from the ECG waveform in addition to the function of delivering a defibrillation shock based on the ECG.

Any ECG ME EQUIPMENT that acquires a 12 LEAD2 ECG signal for the purpose of diagnosis from the interpretation of the cardiac rhythm, conduction, and waveform contour. This includes any device that acquires diagnostic resting ECG as well as any other type of ECG ME EQUIPMENT that claims to have the capability of acquiring a diagnostic 12 LEAD ECG. ECG ME EQUIPMENT that produces a diagnostic 12 LEAD ECG from non-standard electrode positionsis excluded from the scope of DIAGNOSTIC ECG ME EQUIPMENT. Devices which have multiple purposes and include the DIAGNOSTIC ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.

AMBULATORY ECG ME EQUIPMENT

Any ECG ME EQUIPMENT that acquires an ECG signal from an AMBULATORY PATIENT. Examples of AMBULATORY ECG ME EQUIPMENT include Holter systems and continuous long-term AMBULATORY full disclosure recording systems; Holter recorders, mobile cardiac telemetry and long-term AMBULATORY patch recorders, event recorders, and non-continuous loop recorders. Devices which have multiple purposes and include the AMBULATORY ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.

P 123 – 4 New Edition IT Adoptions

P123 – Proposed New Standard IT Adoptions

1.1 General

This Standard applies to frames and covers for maintenance holes and catchbasins.

1.2 Terminology

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.

1.1 General

This Standard assesses the performance of package wastewater treatment plants that are intended to treat either mixed-wastewater or greywater drainage to produce a treated effluent water quality suitable for non-potable water-reuse applications with a treatment capacity of up to 10 000 L/d (2650 gal/d) or less.

This Standard also covers site-assembled components included in package wastewater treatment plants.

Notes:

1) In this Standard package wastewater treatment plants intended to produce a reuse water quality suitable for authorized non-potable water applications from either mixed-wastewater or greywater drainage are also referred to as package plants.

2) This Standard is not intended to limit the use of multiple package plants to achieve an aggregate treatment capacity greater than 10 000 L/d (2650 gal/d) or as determined by the authority having jurisdiction.

3) This Standard does not cover custom-engineered wastewater treatment systems. For such systems, the authority having jurisdiction should be consulted.

4) Greywater diverters are covered in ASME A112.18.2/CSA B125.2.

5) See Annex F for information on design, warranty, and service policy.

1.2 Test methods

This Standard specifies test methods for evaluating the performance of package plants and minimum requirements with regard to

a) materials;

b) design and construction;

c) operation and treatment performance;

d) markings; and

e) instructions and other documentation.

1.3 Terminology

In CSA standards, “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 (nonmandatory) to define their application.

1.4 Units of measure

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only. All references to gallons are to US gallons.

1.Application

This Standard specifies requirements pertaining to the quality and uniformity of softwood lumber and establishes the designation “Canadian Standard Lumber” for lumber that meets the requirements of this Standard (see Clause 4). 

This Standard covers the following topics:

a) accreditation board and agency responsibilities (Clause 5);

b) measurement (Clause 6)

c) standard sizes (Clause 7);

d) grading rule requirements (Clause 8);

f) identification (grade stamps and certificates) (Clause 9); and

g) determination of design properties (Clause 10).

This Standard applies to lumber produced and consumed in and exported from Canada, and for lumber imported into Canada.

This Standard provides for the grading of structural lumber by both visual and mechanical means.

This Standard also includes detailed Annexes covering lumber terminology and lumber industry abbreviations.

This Standard does not cover trade practices, grades (other than grading rules and identification), the details of accreditation board and grading agency inspection procedures, or strength and related properties.

The provisions of this Standard apply to species when the species is included in rules approved by the accreditation board.  Although this Standard applies to softwood lumber, it may be applied to hardwood lumber used in applications that ordinarily use softwood lumber.

2.Terminology

In CSA Standards,

a) “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;

b) “should” is used to express a recommendation or that which is advised but not required;

c) “may” is used to express an option or that which is permissible within the limits of the standard; and

d) “can” is used to express possibility or capability.

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.

3.Units

In keeping with the practice of lumber manufacturers throughout North America, sizes in this Standard are given in board measure units, which are expressed in yard/pound units (see Section 6.1). Equivalent SI (metric) sizes, rounded to the nearest millimeter, are given in parentheses for the sake of convenience in use and in commercial transactions.  The values given in yard/pound units are the standard. The values given in parentheses are for information only.  See Annex E for a discussion of how metric dimensions have been calculated for this Standard.

1.1 Overview

This Standard covers enamelled cast iron and enamelled steel plumbing fixtures, and specifies requirements for materials, construction, performance, testing, and markings.

1.2 Inclusions

This Standard covers the following plumbing fixtures:

a) bathtubs;

b) drinking fountains and water coolers;

c) lavatories;

d) shower bases; and

e) sinks:

i) bar sinks;

ii) clinic sinks;

iii) kitchen sinks;

iv) laboratory sinks;

v) laundry sinks;

vi) service sinks; and

vii) utility sinks.

1.3 Terminology

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; “may” is used to express an option or that which is permissible within the limits of the standard; and “can” is used to express possibility or capability.

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.

1.4 Units

SI units are the units of record in Canada. In this Standard, the yard/pound units are shown in parentheses. The values stated in each measurement system are equivalent in application; however, each system is to be used independently. Combining values from the two measurement systems can result in non-conformance with this Standard.

All references to gallons are to U.S. gallons.

For information on the unit conversion criteria used in this Standard, see Annex A.

1.1 Inclusion

This Standard establishes methods of testing and rating for constant volume and/or variable refrigerant flow gas-fired, heat pumps for space-conditioning performance. The procedures apply to factory-made, space-conditioning, unitary heat pumps which utilize gas as the primary fuel. This includes engine-driven heat pumps, absorption-cycle heat pumps, desiccant type heat pumps, and other gas-fired heat pumps. The heat source/sink for the heat pumps may be outdoor air, ground water, or closed-loop water/brine. The heat pumps may provide the functions of year-round space conditioning either by direct heating and cooling of air or indirectly by the production of heated and chilled water.

Rationale: Explicitly inclusive of variable refrigerant flow-type gas-fired heat pumps. Further changes are clarifications, not a change in scope.

The heat pump may include other functions. Appropriate portions of this Standard may be applied to heat pumps which have a gas input that varies so that the output matches the cooling or heating load, to heat pumps which have a single level gas input which varies as a function of ambient conditions, and to heat pumps which have a constant gas input regardless of load or ambient conditions, and to heat pumps with several discrete levels of gas input. In addition to applying to heat pumps which provide year-round space conditioning, portions of this Standard may be applied to heat pumps which provide space cooling only or space heating only. Service hot water output from heat pumps, solely or in addition to space conditioning, is covered under ANSI/ASHRAE 118.1 and ANSI/ASHRAE 118.2. Also, procedures are provided for testing and rating water-cooled air conditioners and water-cooled chillers which reject condenser heat with a cooling tower, air and water-cooled condensing units, and desiccant ventilation-air dehumidifiers.

Rationale: Clarification, not a change in scope.

Clause 2 lists the references used in developing the Standard.

Clause 3 lists definitions of terms used in this Standard.

Clause 4 lists the thermal testing that is required for each class of appliance. The type of test and the levels of gas input are prescribed. For air-source/sink appliances, the outdoor temperature conditions are specified, and for water-source/sink appliances, the entering source/sink water temperatures are specified.

Clause 5 identifies additional conditions at which the thermal tests specified in Clause 4 are to be conducted. This includes the voltage of auxiliary electric input, indoor air quantities, return air temperatures, water flow rates, and return water temperatures.

Clause 6 outlines the procedures to be followed when thermal testing. This includes steady-state tests and cyclic tests for the cooling mode, and steady-state tests, cyclic tests, and frost accumulation tests for the heating mode.

Clause 7 covers calculation procedures for determining steady-state capacity and input ratings for the appliance operating in the cooling mode. Appropriate adjustments are made to the input and output values determined by the tests to normalize the impacts of auxiliary electric inputs.

Clause 8 covers calculation procedures for determining steady-state capacity and input ratings for the appliance operating in the heating mode. Appropriate adjustments are made to the input and output values determined by the tests to normalize the impacts of auxiliary electric inputs. The next four sections of the standard cover calculation procedures for determining seasonal and annual performance parameters for residential and commercial applications.

Clause 9 covers calculation procedures for determining cooling-mode seasonal output and energy consumption ratings for appliances suitable for installation in residential applications. The steady-state cooling ratings from Clause 7 are required as inputs for these determinations. A sample calculation is provided in Annex A.

Clause 10 covers calculation procedures for determining heating-mode seasonal output and energy consumption ratings for appliances suitable for installation in residential applications. The steady-state heating ratings from Clause 8 are required as inputs for these determinations. A sample calculation is provided in Annex B.

Clause 11 covers calculation procedures for determining annual energy consumption for appliances suitable for installation in residential applications. The seasonal energy consumption data determined in Clauses 9 and 10 are required as inputs for these calculations.

Clause 12 covers calculation procedures for determining cooling-mode average hourly output and energy consumption ratings for appliances suitable for installation in commercial applications. The steady-state cooling ratings from Clause 7 are required as inputs for these determinations. A sample calculation is provided in Annex C.

Clause 13 covers procedures for determining outdoor sound power level ratings for air-source appliances.

Annex A: An informative sample calculation of cooling seasonal performance parameters for residential air-source appliances

Annex B: An informative sample calculation of heating seasonal performance parameters for residential air-source appliances

Annex C:  Covers an informative sample calculation of cooling integrated part load value parameters for commercial appliances

Annex D: Informative list of Harmonized Appliances

Annex E: Informative methods of determining efficiency ratings and operating costs of gas-fired, heat pumps for space-conditioning performance

Annex F: Informative bibliography

1.2 Units of Measure

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.

1.3 Terminology

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 (nonmandatory) to define their application.

1.1 General

This Standard is designed to be used with related occupational or technical standards. It is intended to be referenced by other standards as the primary set of requirements for health and safety management of work in confined spaces.

This Standard is designed for voluntary application in Canadian workplaces. However, the principles established in this Standard are based on best practices recognized internationally. As such they can be applied to any workplace.

Note: At the time of publication, confined space legislation differs from jurisdiction to jurisdiction in Canada. It is the user’s responsibility to determine how applicable legislative requirements relate to this Standard.

1.2 Applications

This Standard specifies requirements for

establishing and maintaining a confined space management program in accordance with OHSMS principles;

the roles and responsibilities of management, the entry team, and the emergency response team;

identification and designation of confined spaces;

design and engineering of confined spaces;

hazard identification and risk assessment relating to work in confined spaces;

management and control of hazards and risks associated with work in confined spaces;

personal protective equipment (PPE) and other equipment used for work in confined spaces;

general safety procedures for confined spaces;

remote monitoring;

training for work in confined spaces;

determining worker capability of performing assigned duties within confined spaces;

emergency plans for rescuing workers in confined spaces;

management of external service providers; and

documentation.

1.3 Exclusions

This Standard does not address safety management of

a) enclosures or structures designed and constructed for continuous human occupancy; or

b) underwater enclosures.

Note: For underwater enclosures, see the requirements for penetration diving specified in CSA Z275.2.

1.4 Terminology

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.

1.5 Units of measure

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.