Health Care and Medical Devices

1 Scope

1.1 This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.

1.2 This document applies to all types of plume evacuation systems (PESs), including

a) portable;

b) mobile;

c) stationary, including dedicated central pipelines;

d) PESs integrated into other equipment;

e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic).

1.3 This document applies to all healthcare facilities where PESs are used, including, but not limited to

a) surgical facilities;

b) medical offices;

c) cosmetic treatment facilities;

d) medical teaching facilities;

e) dental clinics;

f) veterinary facilities.

1.4 This document provides guidance on the following aspects of PESs:

a) importance;

b) purchasing;

c) design;

d) manufacture;

e) documentation;

f) function;

g) performance;

h) installation;

i) commissioning;

j) testing;

k) training;

l) use;

m) risk assessment;

n) servicing;

o) maintenance.

1.5 This document does not apply to the following:

a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;

b) medical vacuum systems which are covered in ISO 7396-1;

c) heating, ventilation, and air-conditioning (HVAC) systems;

d) aspects of laser safety other than airborne contamination; and

e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

The Canadian Deviations are to replace the terms “female” and “male” when referring to connectors in the ISO standard, as a member flagged this when we last reaffirmed the second edition. As well as adopting the 2019 AMD 1 that provides additional content.

This part of ISO 5356 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessories.

This part of ISO 5356 specifies requirements for the following screw-threaded, weight-bearing conical connectors:
— 22 mm connectors;
— 22 mm/15 mm coaxial connectors.

Requirements for the application of screw-threaded, weight-bearing conical connectors are not included in this part of ISO 5356, but are or will be given in the relevant International Standards for specific medical devices and accessories.

NOTE Requirements on cones and sockets are specified in ISO 5356-1.

1.1    General

The Standard describes essential elements and specific requirements and recommendations for the care of persons living with dementia in home and community care settings. It is intended for use by all persons living with dementia as well as groups and individuals who deliver care to persons living with dementia in those settings, including

a)   home and community care service organizations, whether public, private or non-profit.

b)   Agencies involved in the oversight, education and support of home and community care organizations.

c)   health care professionals, administrators, and support personnel employed by the home and community care organization

d)   Care partners; and

e)   subcontractors.

This Standard includes requirements and recommendations for supporting quality of life through directed living standards for persons living with dementia and care partners with specific attention to:

a)   needs assessment.

b)   the health, safety, and well-being of persons living with dementia, and care partners; and

c)   the health and safety of care personnel.

d)   access to education and training to care partners, about dementia, as well as how to support persons living with dementia

e)   workforce recruitment, training, evaluation, and retention.

f)    organizational structures, management systems, resources, policies, procedures and practices.

g)   measures to support person-centered care (including direct involvement of the person living with dementia in care decisions, consistent with their abilities), equal access to care, and respecting the privacy and dignity for all persons living with dementia.

h)  policies to support equal access to services, and to provide care that respects and responds to an individual’s cultural, national, linguistic, religious, and sexual and gender identity.

i)    building public awareness and education around stigma and myths regarding dementia.

j)    planning, management, provision and ongoing evaluation of individualized care plans

k)   evaluation and continual improvement of system-level services to persons living with dementia; and

l)    Basic modifications to the physical environment to support care, where possible.

1.2   Exclusions

1.2.1

This Standard does not comprise a comprehensive set of requirements for home and community care organizations. The scope of the development of this standard is to address the identified need for dementia-specific care requirements for home and community care. The standard shall be used as a supplement to general home and community care standards, to help ensure that the needs of persons living with dementia within the program population are planned for and properly addressed.  It can be used to support implementation or improvement of services to persons living with dementia in both new and existing programs.

1.2.2

This Standard does not address clinical practice.

1.2.3

This standard was created for home and community care settings exclusive of long-term care (LTC), however many of the principles herein are also applicable to LTC settings.

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 (non-mandatory) to define their application.

1.1 Application
This Standard applies to the safe storage, handling, and use of portable oxygen systems for medical or therapeutic use at the patient bedside. It includes portable oxygen systems which provide medical oxygen in high-pressure oxygen cylinders, liquid oxygen systems, and oxygen concentrators. in residential buildings and health care facilities.

1.2 Inclusions
This Standard includes requirements for maximum aggregate storage quantities of gaseous and liquid oxygen.

1.3 Exclusions
This Standard shall not apply to veterinary hospitals, gas mixes containing oxygen (e.g., 50/50 mix of nitrous oxide and oxygen, M size (22L H2O) or larger high pressure cylinders, and liquid oxygen 65L reservoirs or greater) and the safe storage, use, and handling of portable Oxygen systems which are intended for use on a Medical Gas Pipeline System. See CSA Z7396.1 - Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems for further information.

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; “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 Values
The values given in SI (metric) units are the standard. The values given in parentheses are for information only.