1 Scope

This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

— extracorporeal blood circuits;

— plasmafilters;

— haemoperfusion devices;

— vascular access devices;

— blood pumps;

— systems to prepare, maintain or monitor dialysis fluid;

— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

— reprocessing procedures and equipment.

NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

1 Scope

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.

This document does not apply to:

— haemodialysers, haemodiafilters or haemofilters;

— plasmafilters;

— haemoperfusion devices;

— vascular access devices.

NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.

NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

1 Scope

This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.

The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces). NOTE of the two. Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination

This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.

Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.

1 Scope

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This Standard applies to hoists and body-support units (assistive devices) used to transfer, typically by
suspending from above, persons between beds, chairs, stretchers, bathtubs, pools, or other similar
destinations or standing positions, or for supporting portions of the body. For example, this Standard applies to hoists and body-support units often referred to as ceiling lifts, portable lifts, floor lifts, sit-to-stand lifts, bathtub-chair lifts, pool lifts, and their slings and accessories, etc.

[Replace the fourth paragraph with the following]

This Standard does not apply to devices that transport persons between two levels (floors) of a building
(e.g., elevators, escalators, stair lifts, etc.). Similarly, this Standard does not apply to beds, stretchers,
powered lift chairs, wheeled-chairs, or other devices that can be used to transport people short
distances between locations.

[Replace the fifth paragraph with the following]

It does not include methods for the determination of ageing or corrosion of such hoists and body support units.

[Replace the sixth paragraph with the following]

It does not include methods to qualify individual body support units prior to use.

[Add the following note]

Note: This standard specifies requirements and test methods associated with design and manufacturing specifications of hoists and body supports. Please refer to Z10535.2 for safety requirements for lifts for the transfer of persons and related practices, including:
a) installation;
b) commissioning

c) inspection;
d) maintenance;
e) testing (performance-verification);
f) care and use; and
g) cleaning and infection control.

1 Scope

1.1 General

1.1.1 Application

This Standard deals with the following subjects:

a) electrical safety associated with health care provision; and

b) essential electrical systems for health care facilities.

Note: See Clause 3 for the definition of “health care facility”.

1.1.2 Exclusions

1.1.2.1 Veterinary facilities

This Standard is not intended to apply to veterinary facilities, although its electrical safety principles could prove useful in the design, construction, and operation of such facilities.

1.1.2.2 Uninterruptible power systems

Uninterruptible power systems (UPS), which may be used for specific critical applications, are not covered by this Standard.

Note: If a UPS is used within a health care facility, refer to Annex K for more information.

1.1.3 Relationship to the Canadian Electrical Code

Provisions of this Standard are supplementary to the installation requirements specified in Sections 24 and 52 of CSA C22.1, Canadian Electrical Code, Part I, and require compliance with Canadian Electrical Code, Part II standards.

1.2 Electrical safety

1.2.1 Areas

This Standard applies to

a) patient care areas (PCA) of Class A, Class B, and Class C health care facilities; and

b) areas outside health care facilities that are intended for patient diagnosis, treatment, or care involving intentional electrical contact of any kind between patients and medical electrical equipment.

1.2.2 Electrical equipment

This Standard applies to

a) medical electrical equipment;

b) health-care-facility-owned non-medical electrical equipment;

c) patient-owned electrical devices; and

d) the use and management of the equipment and installations in patient care areas.

The electrical equipment described in Items a) to c) can be portable or permanently connected.

1.2.3 Aspects of electrical safety

This Standard deals principally with safety from the hazards of electric shock (see Annex A). Other aspects of electrical safety, such as fires and interference with proper operation, are also addressed.

Note: The Canadian Electrical Code, Part I, specifies the minimum requirements for a safe building electrical installation for supplying utilization equipment in patient care areas, but does not specify requirements for the number, arrangement, and circuit loading of branch circuits and receptacles required for the procedures to be performed. Neither does it state requirements for the use and maintenance of such installations. This Standard builds on the requirements of the Canadian Electrical Code, Part I, and provides this additional information.

1.2.4 Medical risks or benefits

The medical purposes, risks, or benefits of procedures or equipment are the professional responsibility of health care practitioners and, therefore, are beyond the scope of this Standard, which provides general guidelines to ensure the safe use of electrically operated equipment.

1.3 Building electrical installations

This Standard applies to electrical installations in patient care areas of health care facilities.

1.4 Essential electrical systems

Clause 6 applies to the design, installation, operation, and maintenance of the normal and emergency supply required to provide electrical power to those portions of a health care facility’s electrical system in which the interruption of the normal supply can jeopardize effective and safe patient care, the safety of health care facility staff, and public safety. Aspects of emergency electrical power supply systems not covered by Clause 6 are covered by CSA C282.

UPS units are not considered an emergency supply source in accordance with Clause 6 of this Standard and in accordance with Rule 24-306 of the Canadian Electrical Code, Part I.

Note: Some health care facilities have added, or are considering adding, UPS to essential electrical systems to provide improved supply continuity for specific areas or equipment. Annex K describes factors that should be considered by health care facility administration for use of UPS.

1.5 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.