1 Scope
1.1 General
This Standard is intended to form the basis of a QMS within a health care or home setting for the purpose of providing safe, reliable kidney dialysis treatments.
Note: A comprehensive QMS can be achieved when this Standard is used in combination with the following related Standards:
a)
CAN/CSA-C22.2 No. 60601-1;
b)
CAN/CSA-C22.2 No. 60601-2-16;
c)
CAN/CSA-C22.2 No.…
Medical electrical equipment — Part 2-83: Particular requirements for the basic safety and essential...
Scope
This part of IEC 60601 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME
LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME
LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.
The scope of this document includes all light sources except laser.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT…
Purpose
This standard provides LTC home teams, leaders, and governing bodies with criteria and guidelines for delivering resident-centred, high-quality care, enabled by a healthy and competent workforce.
Applicability
This standard applies to teams, leaders, and governing bodies of LTC homes. LTC homes, also referred to as continuing care, personal care, or nursing homes, are settings where…
1 Scope
1.1 Aim
This Standard describes energy model QA and QC rules and procedures to help standardize modelling requirements based on the energy model use case, in order to improve confidence in and consistency of modelling results.
1.2 Methodology
This Standard provides a methodology for classifying energy model use cases.
1.3 Application
This Standard supports the consistent application…
1 Scope
1.1 Application
This Standard can be used in the design and construction of new homes, or in alterations to existing housing, as it pertains to accessibility. This includes the design, construction, and alteration of built environments leading up to, into, and throughout accessible dwellings.
The requirements in this Standard are suitable for permanent dwellings, short-term dwellings…
Canadian medical device reprocessing in all health care settings
1 Scope
1.1 Standard addresses
This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical
devices at each phase of the reprocessing workflow, including
a) establishing a QMS for the MDRA, including
i) key performance indicators;
ii) policies and procedures;
iii) documentation;
iv) roles and responsibilities;
v) management review;
vi) planning…
Data Governance – Part 4: Scalable Remote Access Infrastructure
This standard presents a set of requirements to help organizations mitigate security risks associated
with, and scalability demands upon, enterprise technologies used for remote access.
The standard also provides guidance to organizations needing to react to unprecedented and unplanned
shifts in their workforce to support work-from-home mandates.
This standard applies to all organizations,…
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential...
IEC 60601-2-83:2019+AMD1:2022 CSV is applicable to the basic safety and essential performance of home light therapy equipment, intended for use in the home healthcare environment. Home light therapy equipment is typically used by a lay operator. The scope of this document includes all light sources except laser.
Long-term care home operations and infection prevention and control
1 Scope
1.1 General
This Standard provides guidance on safe operating practices, design, and IPAC in LTCHs while
incorporating a person-centred approach. The Standard takes into consideration what is required during
both normal, day-to-day circumstances and catastrophic events (e.g., outbreaks, epidemics, pandemics,
fires, earthquakes, loss of power). The Standard considers factors such as…