Health Care and Medical Devices

This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.

It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.

The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).

While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.

This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.

This document does not apply to the design, development and industrial production of commercially used IVD medical devices.

This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189.
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document provides requirements and recommendations for supervisors and operators of point-of-
care testing (POCT) services where POCT is performed without medical laboratory training, supervision or 
support. It includes the key components that should be considered to provide safe and reliable POCT results.
Self-testing is excluded from this document.

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.