This Standard specifies requirements for sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g., scalpel blades, trocars, hypodermic needles, and syringes.

This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.

This Standard includes design and functionality requirements; performance testing for single-use and reusable sharps containers; lifespan simulation; cleaning and decontamination; microbiological validation; and quality monitoring for reusable sharps containers.

This Standard is not applicable to outer containers used in the transportation of filled single-use sharps containers. 

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

[Replace the second paragraph with the following]

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.